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The Universe of Pre-filled Syringes & Injection Devices
The Parenteral Drug Association presents:
2017 PDA Europe Conference, Exhibition
7–8 November 2017 Austria Center
Vienna | Austriapda.org/EU-UPS2017
Improving Patient Outcomes with Innovative Drug Delivery
14th The Universe of Pre-filled Syringes & Injection DevicesThe Parenteral Drug Association warmly invites you to join the 14th edition of The Universe of Pre-filled
Syringes and Injection Devices!
Since its first edition in 2004, the conference has become a fixture in the calendar for the pharmaceutical
industry, and a must-attend event for everyone working in the fields related to parenteral drug and device
development.
For its 14th year, the European event once again returns to Vienna, one of Europe’s most vibrant cities.
The Austrian capital perfectly integrates tradition and innovation, with an overwhelming cultural offer of the
arts and the sciences.
Geographically situated between central and southeastern Europe, with its many neighboring countries,
Vienna holds great potential for interaction, exchange of expertise and networking.
By coming to Vienna, you will become part of this cultural melting pot, with unlimited potential for getting
involved in the vast professional network of PDA members, speakers and special guests.
Another impressive opportunity to gain access to key decision makers from the pharmaceutical industry as
well as government representatives, service providers and manufacturers awaits you!
Join us this fall in Vienna and be part of the world’s largest event on this subject.
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Introduction 4
Activities at a Glance 4
Pre-Conference Workshops 5
Venue 11
Main Event 12
Letter from the Chairs 13
Conference 14
Conference Agenda 14
Exhibition Floor Plan 20
PDA Education Program 23
Training Course Agendas 23
General Information 33
Registration Form 34
VENUEAustria Center ViennaBruno-Kreisky-Platz 11220 Vienna | Austriawww.acv.at
ORGANIZERPDA EuropeAm Borsigturm 6013507 Berlin | GermanyTel: +49(0) 30 43 65 50 80Fax: +49(0) 30 436 55 08 66info-europe@pda.org
MEDIA PARTNER
International Pharmaceutical Industry Supporting the industry through communication
IN
TERNATIONAL PHA
RM
ACEUTICAL IN
DU
STRY
TABLE OF CONTENTS
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ACTIVITIES AT A GLANCE
7:00 – 16:30The Universe of Pre-filled Syringes &
Injection Devices
9:00 – 16:00Exhibition, Live Demos &
Poster Session
CONFERENCE
7:30 – 18:00Registration
9:00 – 18:30The Universe of Pre-filled
Syringes & Injection Devices
9:00 – 18:30Exhibition, Live Demos &Poster Session
18:30 – 21:30Color the NightNetworking Event
Tuesday, 7 November
6:30 – 18:00Registration
Wednesday, 8 November
PRE- CONFERENCE WORK SHOPS
8:00 – 18:00Registration
10:00 – 18:00Workshop
Innovative Drug Delivery Systems/Combination Products
10:00 – 18:00WorkshopImpact of Pre-filled Syringe
Packaging Components on Biopharmaceuticals
10:00 – 17:30Workshop
Connected Health & Drug Delivery
Monday, 6 November
PDA EUROPE EDUC ATION PROGR A M
8:00 – 18:00Registration
8:00 – 12:30Registration
9:00 – 17:00Workshop
Drug Delivery Systems: Global
Technical, Regu-latory and Quality
Challenges
9:00 - 16:00Workshop
Drug Delivery Systems: Global
Technical, Regu-latory and Quality
Challenges
9:00 – 18:00Training Course
Best Practices and Points to
Consider in Aseptic
Processing
9:00 – 17:30Training Course
Container Closure Integrity
Testing
9:00 – 16:30Training Course
Container Closure Integrity
Testing
9:00 – 18:00Training Course
Rapid Microbiological
Methods
9:00 – 18:00Training Course
Development and
Manufacturing of Pre-filled
Syringes
9:00 – 17:00Training Course
Container Closure Development
9:00 – 17:00Training Course
Development and
Manufacturing of Pre-filled
Syringes
9:00 – 16:30Training Course
Rapid Microbiological
Methods
9:00 – 16:30Training Course
Best Practices and Points to
Consider in Aseptic
Processing
Thursday, 9 November
Friday, 10 November
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6 November 2017Innovative Drug Delivery Systems / Combination ProductsOne-Day Workshop
6 November 2017Impact of Pre-filled Syringe Packaging Components on BiopharmaceuticalsOne-Day Workshop
6 November 2017Connected Health & Drug DeliveryOne-Day Workshop
Pre-Conference Workshops
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PRE-CONFERENCE WORKSHOP
Innovative Drug Delivery Systems/Combination ProductsFrom Project Initiation to Life Cycle Management
Workshop DescriptionIncreasingly, parenteral products are injected using devices like pen-injectors, auto injectors and wearable pumps. Typically, the primary containers are pre-filled syringes and cartridges. The materials are glass or polymer. Special applications have treated surfaces or coated materials.
Starting with a key note presentation describing the needs of the pharmaceutical and biopharmaceutical industry, this workshop will give an overview of currently used devices. Technical aspects, handling and training, as well as regulations will be highlighted. Device companies will present their products and focus on the most current drug delivery requirements such as:
• Mixing technology for liquid/liquid or lyo/liquid formulation combinations
• Large Volume• High Viscosity• High Precision Dosing
Challenges in development impeding a life cycle approach will be one of the themes of the workshop.
Learn from suppliers’ solutions, and hear guest speakers and facilitators share approval and life-cycle management experiences from developing their drug delivery combination products.
Listen to the latest trends in final assembly during drug product manufacturing and what the benefits of target-focused training for users and health care professionals can be. Learn which activities succeeded and hear about the lessons learned. Interact with other participants and speakers during panel discussions and exchange on all issues vital for ensuring success of your product.
Who Should Attend:The target audience for this workshop is from departments like Device Development, Compliance, Operations, Regulatory Affairs, Manufacturing, Pharmaceutical Formulation and Process Development, Business Development, Marketing, Procurement, CMC, Distribution, Packaging, Quality Assurance/Con-trol, Clinical Affairs.
Learning Objectives:Upon participation of this workshop you will be able to:• Use combination products to gain market differentiation• Identify to best possible and innovative drug delivery solution for your drug product• Understand the latest trends in drug delivery technology• Implement world class training solutions to prepare for a smooth market entrance • Understand best in class assembly concepts
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WORKSHOP AGENDA
Thomas Schoenknecht, PhD, PDA IG Leader Combination Products, SHL
Thomas Schönknecht is currently Executive Director, Business Development at SHL Group, with responsibility for global Business Development, Key Account Management and new Technology Evaluation within SHL’s Medical division. Thomas has over 20 years of experience in pharmaceutical industry in various leading roles in project management, research & development and business development. He received his Ph.D. in Biophysical Chemistry from the Max-Planck-Society and the University Goettingen, Germany and a Master’s
degree in Chemistry from the University Goettingen. He is currently active as PDA interest group leader combination products in Europe. In addition he had been active as member in various DIN ISO committees regarding primary packaging materials and drug delivery devices.
Workshop Chair
2 Nov 2017
Monday, 6 November 2017 10:00 – 18:00
10:00 Welcome and Introduction Thomas Schoenknecht, SHL
10:15 Data-driven Discovery: Knowledge Management for Drug Delivery Technologies
Jeffrey Schacherl, Amgen Christian Marc Schmidt, Schema Design
10:45 Device Companies Presentation Overview of Devices by• Becton Dickinson • Bespak
• BIOCORP • Dali Medical Devices
• Haselmeier• Ypsomed
12:30 Lunch Break
13:30 Device Companies Presentation (cont.)Overview of Devices by• Sensile • SHL • Oval Medical • West
14:30 Panel Discussion:Drivers of Life Cycle Management in Pharmaceutical Companies
15:30 Coffee Break
16:00 A Novel Autoinjector for High Volume, High Viscosity, and Outstanding Usability
Avi Eliahu, Genentech
16:30 Device Training for Patients & Healthcare Providers Joe Reynolds, Noble
17:00 Considerations on Lifecycle Management in Scope of the Changing Regulatory Landscape• Recent changes on standards and regulatory expectations/requirements• Considerations on legacy products in light of changing standards
Rosemary Gonzalez, SHL
17:30 Q&A on Real Cases, Discussion
18:00 End of Pre-Conference Workshop
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PRE-CONFERENCE WORKSHOP
Impact of Pre-filled Syringe Packaging Components on Biopharmaceuticals
Workshop DescriptionParenteral drug delivery using pre-filled syringes and cartridges in combination with devices is of great importance, especially for the application of biopharmaceutical products.
The development of such delivery systems is complex and therefore it is important to consider critical aspects early on in development. This workshop considers the potential influences of primary packaging components on the quality, in particular for biopharmaceuticals. The most relevant aspects are the quality and the chemical and physical interactions of the packaging material with the product. Special considerations are given to the influence of particles, extractables and leachables, silicon oil and handling on the product quality, e.g. aggregation, degradation routes and stability. Experts from academia, the pharmaceutical industry and suppliers of packaging components will share their experiences. There will be plenty of time for discussion, interaction and questions you may have.
Who Should Attend:• Professionals in pharma dealing with development and manufacturing of biopharmaceuticals, con-
tainer and device development, quality and regulatory functions
Workshop Co-Chairs
John Carpenter, University of Colorado
John F. Carpenter is Professor of Pharmaceutical Sciences at the University of Colorado (CU) and Co-Director of the CU Center for Pharmaceutical Biotechnology. His research focuses on mechanisms for protein degradation and stabilization. John has published >270 peer-reviewed papers and holds more than 30 patents. He is an Editor for Journal of Pharmaceutical Sciences and serves on several Editorial Advisory Boards. He has received The Ebert Prize and the American Association of Pharmaceutical Scientists (AAPS) Research Achievement
Award in Biotechnology. He is a Fellow of the American Association for Advancement of Science, the AAPS and the National Academy of Inventors.
William Dierick, Terumo
William Dierick is Fellow - Science & Technology of TERUMO, a global research & development company, offering a wide range of innovative products related to drug delivery devices and injection technology, cardiology and cardiovascular systems, transfusion, patient monitoring and clinical systems. With extensive experience in the Medical and Pharma sector for more than 40 years, William has held various positions in Terumo, covering quality assurance, manufacturing, product development & engineering, project management, marketing,
corporate planning and business development. He serves as expert of ISO/TC76 and ISO/TC84 and is an active member of Eucomed (MedTech Europe) and volunteer of PDA.
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WORKSHOP AGENDA
2 Nov 2017
Monday, 6 November 2017 10:00 – 18:00
10:00 Welcome William Dierick, TERUMO
John Carpenter, University of Colorado
KEYNOTE PRESENTATIONS
10:10 Aggregates, Particles and Patient Immunogenicity with Biopharmaceuticals
John Carpenter, University of Colorado
10:40 Factors Affecting Stabilities of Biopharmaceuticals in Pre-filled Syringes
Susumu Uchiyama, Osaka University
11:10 Packaging Components and Biopharmaceuticals: Quality Aspects from Industry Perspective
Hanns-Christian Mahler, Lonza
11:40 Q&A - Discussion
12:00 Lunch Break
Session 1 Aggregation Phenomena
13:00 Protein – Device Compatibility Flora Felsovalyi, Roche
13:30 Characterization of Particles and Practical Implications Linda O. Narhi, Amgen
14:00 Ex-Vivo Risk Assessment of Immunogenicity Mark Fogg, Abzena
14:30 Q&A – Discussion
15:00 Coffee Break
Session 2 Particles
15:30 Particulates in Sterile Drug Products: Testing, Contributions and Mitigation from Packaging Components
Fran DeGrazio, West
16:00 Particles in Packaging Components: Numbers and Chemical Composition Markus Lankers, Rap.ID
16:30 Q&A - Discussion
Session 3 Extractables & Leachables
16:45 Extractables and Leachables: Impact of Packaging Components on Biopharmaceuticals
Piet Christiaens, Toxikon
Session 4 Functionality
17:15 Needle Clogging of Staked-In-Needle PFS with High Concentration Protein Therapeutics
Monica De Bardi, Roche
17:45 Q&A - Discussion
17:55 Closing Remarks by Co-Chairs
18:00 End of Workshop
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PRE-CONFERENCE WORKSHOP
Connected Health & Drug Delivery Improved patient convenience and adherence through new technologies
Workshop DescriptionMeanwhile there are a number of technical solutions for smart devices and connected health. In this workshop we will focus on the patient s perspective. How do patients accept smart devices and what might be challenges for implementation? Patients will talk about their experiences and companies will present approaches they took to get patient s acceptance.
Who Should Attend:
• Professionals from pharmaceutical and supplier companies involved in functions such as clinical, pharmaceutical and container development, as well as business development and marketing, but also people dealing with regulatory issues.
Markus Bauss, Managing Director, SHL Connect
Markus has over 10 years' experience in the area of pharmaceutical packaging in various leading roles such as global key account management, research & innovation and business development. Looking at upcoming new technologies such as smart phones, mobile apps and connectivity, Markus started his technology Start-Up company ConnectMeSmart GmbH in 2013. In 2015, SHL Group and ConnectMeSmart partnered up in the Joint Venture SHL Connect to investigate the market for connectivity, emerging technologies and explore their
potential application within each of SHL Group’s companies. From 2004 to 2014, Markus was working for Schreiner MediPharm, a leading supplier of advanced labeling solutions. Working in the U.S. and Europe, Markus contributed with innovative products, such as Needle-Trap, a label integrated needle stick prevention solution. Markus studied process engineering at the Technical University of Clausthal and started his career in environmental & recycling technology at RWE in Germany in 1997, prior to moving to the pharmaceutical area.
Workshop Chair
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WORKSHOP AGENDA
2 Nov 2017
Monday, 6 November 2017 10:00 – 17:30
10:00 Welcome Markus Bauss, SHL Connect
10:30 The Patient s Perspective• Expectations of the patient about technology - Two diabetes patients
share their experiences
11:00 Products by Patients for Patients • Experiences, key success factors and lessons learned establishing a mo-
bile health platform for diabetes care
Fredrik Debong, mysugr
11:30 Injection Devices – How do YOU do it ? • User centric drug delivery device development • Applying new technology in design process and usability testing to en-
sure patient convenience
Markus Bauss, SHL Connect
Jez Clements, Cambridge Design Partnership
12:00 Discussion
12:30 Lunch Break
TECHNOLOGY & DIGITAL HEALTH PLATFORMS
13:30 The Evolving Perspective of Digital Health Cliff Lee, Flex
14:00 The Internet of Health• Wireless sensors for prevention, cure and care
Chris van Hoof, Imec
14:30 The Move to Connected Devices• Key elements to consider in product design
Chris McKenzie, Batelle
15:00 Why Make Your Existing auto-injector “smart”• Comparison of benefits of different accessory form factors and integra-
tion into a connected health platform
Brian Lynch, West
15:30 Coffee Break
APPLICATIONS IN SPECIFIC THERAPIES
16:00 Connected Health & Rare Diseases • Opportunities through new technology
Sujit Basu, Shire
16:30 Creating a Digital Ecosystem to Support Repatha Patients• The potential to support patients before and after the prescription of
drug products through complementary digital technologies
Shawn Davis, Amgen
17:00 Panel Discussion
17:30 End of Pre-Conference Workshop
PRE-CONFERENCE – EXHIBITION FLOOR PLAN
Workshop Rooms
1
10
9
4
5 876
Teru
mo
IWAT
A
Table Top 2 m x 2,5 m (5 m2)
Buffet/Coffee Station
TO EXHIBIT:PDA meetings and conferences are a great opportunity for your company to gain on-site exposure in front of highly-qualified, upper-level professionals in the pharmaceutical and biopharmaceutical industry. Exhibition and Sponsorship Opportunities are available. A basic exhibition package for this event is priced 1.995 Euro net. For more information please contact expo-europe@pda.org
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C a r e f u l l y C r a f t e d
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World leader in integrated containment and delivery systemsPatient Focus: Sharing our partners’ goals of improving patient health
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EXHIBITION HALL
CONFERENCE AREA
ENTRANCE
TRACK A
TRACK B TRACK C
Access to Parking
D
KG
PDA Registration
Smart Phone Loading Stations
Speakers Ready Room(Room 2.31)
DemoBooth 1
DemoBooth 2
DemoBooth 3
DemoBooth 4
DemoBooth 8
DemoBooth 7
DemoBooth 6
DemoBooth 5
WC
WC
POSTER SESSION
E X HIB I T H A L LC AT ER IN G A R E A
EXHIBITION ARE A
Austria Center ViennaLevel -2 (Brown Level)
DETAILED CONFERENCE EXHIBITION FLOOR PLAN ON PAGES 22–23
VENUE
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MAIN EVENT
Join our Welcome Party at the Highest Point of Vienna
6 November 2017 19:30 - 22:30Meliá Hotel | BAR 57Donau City Strasse 71220 Vienna
proudly provided by
Included in full Conference and Exhibition Registration Fee. First come first served. See details on Registration Form.
7–8 November 2017
The Universe of Pre-filled Syringes and Injection Devices
7 November 2017
7:30 Registration | Welcome Coffee & Exhibition
8 November 2017
6:45 Registration | Welcome Coffee & Exhibition
Conference
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Dear Colleagues,
During the last decade, PDA’s Universe of Pre-filled Syringes and Injection Devices has become the must-attend meeting for everyone working in the field, and is now the world’s largest conference on this subject. We are looking forward to welcoming you to the 14th edition of this event, to be held 7–8 November 2017 at the Austria Center Vienna.
There is a continued process in the pharmaceutical and biopharmaceutical industry to improve the application of injectables. Starting from primary packaging solutions to devices with increased functionalities, new concepts are being developed to better serve the patient needs. Innovations cover a broad range like new materials, new devices, smart devices, special application systems for challenging formulations. Together with these innovations new manufacturing, handling and testing requirements need to be developed. Furthermore, regulatory demands are constantly changing as well, posing challenges to everyone involved in pharmaceutical science, technology and manufacturing of parenterals.
The Universe of Pre-filled Syringes and Injection Devices brings together industry and regulatory experts annually to share their experiences, new developments, regulatory considerations, trends and best practices. Do not miss the opportunity to gain access to and network with key decision makers from the pharmaceutical industry as well as suppliers and manufacturers.
The Austria Center in Vienna has proven to be the ideal location for PDA Europe‘s largest event, offering seemingly endless space and possibilities to create a very unique atmosphere, thereby contributing to the event‘s tremendous success in 2015. Austria‘s largest conference centre is located in the heart of the United Nations’ City Department of Vienna, only a few minutes from the center of one of Europe’s most vibrant cities. Join us there, the perfect place to explore and get immersed in the pre-filled syringes universe!
Sincerely, the Co-Chairs
LETTER FROM THE CO-CHAIRS
SCIENTIFIC PROGR AM PL ANNING COMMIT TEE
Mathias Romacker, Conference Co-Chair, Pfizer
Hanns-Christian Mahler, Conference Co-Chair, Lonza
Markus Bauss, SHL Group
Michael Betz, Roche/Genentech
Christina Braden-Moore, BD Medical
William Dierick, Terumo
Olivia Henderson, Amgen
Laurent Jeanmart, GlaxoSmithKline
Lei Li, Eli Lilly & Co.
Manfred Maeder, Novartis
Brigitte Reutter-Härle, Vetter
Mike Schäfers, West
Michael Selzer, Regeneron
Ian Thompson, Ypsomed
Georg Roessling, PDA Europe
Sylvia Becker, PDA Europe
Hanns-Christian Mahler, PhD Conference Co-Chair, Lonza
Mathias Romacker, PhD Conference Co-Chair, Pfizer
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CONFERENCE AGENDA
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Tuesday, 7 November
9:00 Welcome: Opening Remarks & Introduction Georg Roessling, PDA Europe
Mathias Romacker, PfizerHanns-Christian Mahler, LONZA, Conference Co-Chairs
Opening Plenary: Current Trends & Future Outlook
Moderator: Mathias Romacker, Pfizer
Our conference on Pre-filled Syringes and Injection Devices aims to highlight future technology and regulatory trends of all aspects related to application device technology. At the center of our Universe of Pre-filled Syringes and Injection Devices, however, is the patient. Working in the pharmaceutical industry, regulatory agencies or industries supplying and enabling us to develop and to market these cutting-edge pharmaceutical products and delivery systems, we all are committed to serving patients both in developing countries as well as industrial nations. Safe and efficient application of complex biologics, whether to merely reduce fear of needle and pain, or to increase patient s adherence, improve compliance, reduce waste, etc., are our core goals. Smart devices and connected technologies will open up new horizons in our healthcare universe, providing patients with easier, safer and more effective solutions of drug administration. This and more key drivers for advancing the development of pre-filled syringes and injection devices will be presented over the course of these two days!
KEYNOTE PRESENTATIONS
9:15 The Evolving Perspective of the Pharma Company on Devices and Connectivity
Simon Wilson, Pfizer
9:50 Finding the Right Solution for the Patient: Using Novel Devices to Deliver Molecules from an Increasingly Complex Pipeline
Sheldon Moberg, Amgen
10:25 Coffee Break, Poster Session & ExhibitionFeaturing live Demo OPTIMA Machinery Booth #1
11:10 Device Development for Biosimilars Florian Turk, Sandoz Biopharmaceuticals
11:45 Smart Devices - How to Unlock their Potential in the Real World Tobias Handschuh, Ernst & Young
12:20 Discussion, Q&A
12:45 Lunch Break, Poster Session & ExhibitionFeaturing live Demos
13:45 Transition to Parallel Tracks
Hal
l D
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CONFERENCE AGENDA
P A R A L L E L T R A C K S
Hall D Hall G Hall K
TRACK A TRACK B TRACK CPatient-Device Interface Manufacturing and Technology Marketing and Business
Development
Session 1 New Applications & Challenges Development Marketing & Lifecycle Management
Moderator: Janice Adkins, BD Hanns-Christian Mahler, LONZA Manfred Maeder, Novartis
14:00 Foundational Research on Subcutaneous Injection Physiology to Improve Biologics Delivery Systems and Patient Experience
Michael W Harrison, Eli LillyGraham Jones, Tufts Medical School
Formulation & Administration of Ocular Dosage Forms – Requirements and Challenges
Dhanajay Jere, Lonza AG
Syringe Auto Injector Portfolio Commercialization Development – Challenges and Opportunities
Chris Mitchener, Eli Lilly
14:25 Advances in Intradermal Drug Delivery - From Vaccines to Immunotherapy and Beyond
Gal Admati, NanoPass Technologies
High Volume Injectors: Case Study of an Assessment & Compatibility Test with a Biologic Drug Product
Pierre Goldbach, Roche
Wearable Injectors – Would The Real Driver Stand Up Please
James Blakemore,Cambridge Consultants
14:50 Lucentis Pre-filled Syringe – Challenges and Opportunities
Marie Picci, Novartis
Control Strategy for Combination Products
Christof Golla, Novartis
Commercial Success of a 3rd Generation Digital-Auto Injector: Commercialization, Sustain ability and Environmental Impact
Steven Lynum, Panasonic-Healthcare Takashi Hanada, JCR Pharmaceuticals
15:15 Q&A, Discussion Q&A, Discussion Q&A, Discussion
15:30 Coffee Break, Poster Session & ExhibitionFeaturing live Demo OPTIMA Machinery Booth #1
16:15 Transition to Parallel Tracks
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CONFERENCE AGENDA
P A R A L L E L T R A C K S
Hall D Hall G Hall K
TRACK A TRACK B TRACK CPatient-Device Interface Manufacturing and Technology Marketing and Business
Development
Session 2 Smart Devices Manufacturing Investment
Moderator: Markus Bauss, SHL Connect Mike Selzer, Regeneron Mathias Romacker, Pfizer
16:30 Highlights of Smart Devices Pre-Conference Workshop
Markus Bauss, SHL Connect
Challenges in the Filling of Drug Product Formulations
Simon Hanslip, GSK Vaccines
Pharma Perspective on Device and Development Models and Investment
Nic Bowman, Pfizer
16:55 The Changing Diabetes Landscape – Linking Diagnostics with Injection
Aileen Kinsella, WEST
Building a Flexible Robotic Small Scale Filling Line
Martin Bultmann, AbbVie
Technical Integration of Device Systems and Associated Business Process to Accelerate Innovation
Justin Wright, Eli LillyMarty Coyne, Matchstick
17:20 Smart Drug Delivery Devices for Home Use
Martin Koch, Roche
Clinical Manufacturing Flexibility
Susanne Resatz, Vetter
Funding and Building a Business that Provides Pharma Innovations in Drug Delivery
John Merhige, Credence MedSystems
17:45 Improving Patient Outcomes with Mixed Reality and Artificial Intelligence Technologies
Kai Worrell, WorrellMatt Gottschalk, Worrell
Pre-fillable Syringe Selection Criteria for Vaccine: Technical Comparison of Several Syringe Types
Laurent Jeanmart, GSKNicolas Eon, SCHOTT
Case for Re-Usable Autoinjector
Björn Knud Andersen, Medicom
18:10 Q&A, Discussion Q&A, Discussion Q&A, Discussion
18:30 Networking Event Color the Night
I n c l u d e d i n f u l l C o n f e r e n c e a n d E x h i b i t i o n R e g i s t r a t i o n F e e . F i r s t c o m e f i r s t s e r v e d . S e e d e t a i l s o n R e g i s t r a t i o n F o r m .
NETWORKING EVENT
7 NOVEMBER 2017
18:30 - 21:30 ■ Hall X1
VIENNA AUSTRIA CENTER
DRESS CODE: CASUAL COLORFUL ATTIRE
CONFERENCE AGENDA
Wednesday, 8 NovemberHall D Hall X
7:30 Morning SessionModerator: Georg Roessling, PDASpeakers: Tony Stauffer, ptiChristopher Bureau, Stevanato Group Jack Auld, Altaviz
PDA Interest Group Meeting Packaging ScienceJoin us for discussion of selected technologies and posters!Moderators:Derek Duncan, LIGHTHOUSEBettine Boltres, WEST
8:45 Welcome Coffee, Poster Session & Exhibition
P A R A L L E L T R A C K S
Hall D Hall G Hall K
TRACK A TRACK B TRACK CPatient-Device Interface Manufacturing and Technology Marketing and Business
Development
Session 3 Clinical Needs Processing & Assembly Market Trends & Reimbursement
Moderator: Mike Schäfers, WEST Michael Betz, Roche Brigitte Reutter-Haerle, Vetter
9:00 Future of Parenteral Drug Delivery - Wearable Injector: Latest Trends Development and Innovation
Sudeshna Dutta Ray, Amgen
Injectable Drug Delivery - Rethinking Best Practice in Manufacturing based on Smart Objects & Intelligent Machinery
Markus Bauss, SHL ConnectEgmont Semmler, Groninger
Market Trends & Developments
Brigitte Reutter-Haerle, Vetter
9:30 De-risking Clinical Trial Outcomes through Preclinical In-Vivo Models for Large Volume Subcutaneous Injections
Natasha Bolick, BD Medical
Finished Pre-filled Syringes Integrity Testing: Method Development, Validation and 100% in-line High Speed Solution
Giovanni Golinelli, Bonfiglioli Engineering
Influence of Outcomes-based Reimbursement on Drug Delivery Technologies
Scott Gibson, Amgen
10:00 Assessing the Pain in Different Injection Sites
Chris Muenzer, Roche
Device Assembly: Best Practices and Lessons Learned for Successful Device Assembly Execution and Industrialization
Jovo Dragicevic, AbbVie
Payer Perspectives on the Drug Delivery Device Value Proposition: Opportunities, Challenges and Implications
Max Cambras, LEK
10:30 Coffee Break, Poster Session & Exhibition Featuring live Demo Booths
11:00 Transition to Parallel Tracks
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P A R A L L E L T R A C K S
Hall D Hall G Hall K
TRACK A TRACK B TRACK CPatient-Device Interface Manufacturing and Technology Marketing and Business
Development
Session 4 Human Factors Inspection Business Strategies
Moderator: Ian Thompson, Ypsomed Hanns-Christian Mahler, LONZA William Dierick, Terumo
11:15 New Methods of Measuring Device Usability: Bridging The Gap Between Human Factors and Clinical Studies
Vladimir Matejak, Pfizer
High Speed Automated Inspection with Container Closure Integrity Testing for Pre-filled Syringes
Wes Maharas, Eli Lilly Rene de Munk, Seidenader
The Crossroads of Pharma Lifecycle Management - How Best Practices Determine Winners and Pitfalls
Christian Herget, BD Medical
11:35 An Actual-Use Human Factors Study for an Autoinjector
Florian Wildenhahn, Roche
A Case Study for Mitigation of Visual Particulate in Glass Syringe Manufacturing
Luis Baez, Amgen Anthony Vico, OMPI
The Furosemide Story: Transforming a Heart Failure Drug from IV to SC On-body Injection
Gerhard Mayer, Sensile-Medical John Mohr, SCPharmaceuticals
11:55 Application of Eye-Tracking for the Development of New Self-Injection Systems: Insights from the SmartPilot Case Study
Andreas Schneider, Ypsomed
A New Option: Silicone-Free Plunger and Bare Glass Barrel
Russell Hornung, WL GoreJohn Holcombe, WL Gore
Autoinjector Selection Process for a Pharmaceutical Drug Product
Jörg Sielemann, Roche
12:15 Q&A, Discussion Q&A, Discussion Q&A, Discussion
12:30 Lunch Break, Poster Session & Exhibition – Featuring live Demo OPTIMA Machinery Booth #1
Closing Plenary Moderator: Georg Roessling, PDA Europe
13:45 Manufacturing Highlights: Syringe Filling, Device Manufacturing
Jerry Cacia, Roche
14:15 Evolution of UPFS - From Little Beginnings to a Vastly Extended Universe
Mathias Romacker, PfizerHanns-Christian Mahler, LONZA
14:30 Coffee Break, Poster Session & Exhibition – Featuring live Demo Booths
15:00 The Future of Parenteral Drug Delivery in a Connected Health Ecosystem
Divakar Ramakrishnan, Eli Lilly
15:30 Closing Panel Discussion: Improving Patient Outcomes with Innovative Drug Delivery - Expectations for the Future
Moderators:Manfred Maeder, NovartisLaurent Jeanmart, GSK
16:30 Closing Remarks & End of the Conference Georg Roessling, PDA Europe
Hal
l DCONFERENCE AGENDA
22 pda.org/EU-UPS2017
l Data Communication via NFC (Injection History, Temperature, All data log)
l Whole Device stored in the fridgel Guidance for next step by LCDl Reminder Message by LCDl Build-in Thermometer
l Handy and Needle Hidden for kidsl Data Communication with server via NFCl Dosing Volume Control by Remote
Controllerl Animation and Music during Injectionl Stable Injection by Large Positioning End
CE Mark PendingDemonstration purpose OnlyConcept Design
Not for Salesin Europe
Panasonic Healthcare’s Digital Injectors
Mr. Rentaro Nakaya2-38-5 Nishishimbashi, Minato-ku, Tokyo105-8433, Japan
In April 2018, Panasonic Healthcare Co., Ltd will be renamed PHC Corporation
T : +81-70-1457-2273E : nakaya.rentaro@panasonic-healthcare.comW : https://www.panasonic-healthcare.com/
Come Join us!Tuesday, November 7th14:50 Hall K, Track C
Commercial Success of a 3rd Generation Digital-Auto Injector:Commercialization, Sustainability and Environmental Impact
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For more information visit www.ypsomed.com/yds Ypsomed AG // Brunnmattstrasse 6 // 3401 Burgdorf // Switzerland T +41 34 424 41 11 // info@ypsomed.com
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ypsomed_PDA_ups.pdf 1 26.09.17 10:20
E X H I B I TO R Booth
3p Innovation X113
Afton Scientific Y42
altaviz G8
Apex Aseptic Products X40
Aptar Pharma X48 + X49
Atec Sterile Technology Y51
Balda X60 + X61
Batelle Memorial Insititute X123
Baumann Medical X27
Bausch Advanced Technologies X06
Bausch + Ströbel X15 + X16 + X17
BD Medical X81 + X89
Bespak X80
BioCorp X90 & G10
Bosch X09
Brevetti Angela X105
Brevetti CEA X102 + X103
Bühler Motor X32
Cambridge Consultants X62
Cambridge Design Partnership X92
CAS Clean-Air-Service Y33
CC Biotechnology Corporation X66
Cook Pharmica X50 + X51
Copernicus X26
Credence MedSystems X11
CSS - Connecticut Spring & Stamping Y44 + Y45
Dali Medical Devices X65
Dara Pharmaceutical Packaging X84
Datwyler Pharma Packaging X97
DuoJect Medical Systems X115 + X116
Dymax X124
E3D Elcam X44
Enable Injections X 120
Eveon X111
Fareva X01
Fargo Automation X53
Flextronics Medical X21
Fresenius Kabi X104
Früh X121
Gateway Analytical X87
Gerresheimer X93 + X94
Getinge Y46
Gore X108 + X119
Groninger X85
Harro Höfliger X15 + X16 + X17
Haselmeier X35
Heuft X04
IGS GeboJagema X37
IMA Life Y35
Insight Product Development X63
Insulet X99 + X112
Kahle Automation X98
Lighthouse Instruments X07
Lonza X79
Lyophilization Technology X106
Medicom Innovation Partner X68 + X69
Medtech Y35
Merck X34
MGC Mitsubishi Gas Chemical Company X76
Mikron Automation X47
Multivac X55
Nemera X 45
Nipro Europe X12 + X13 + X14
Noble X41+X42
OMPI X60 + X61 & G3
One World X46
OPTIMA Machinery Booth 1
Owen Mumford X86
Panasonic Healthcare X43
PDA Europe Y48
Phillips Medisize X68 + X69
100
X01
X50
X51
X52
X53
X55
X56
X57
X58
X02 X03 X04 X05 X06 X07 X08 X09 X11 X12 X13 X14 X15 X16 X17 X18
X21 X22 X23 X24 X25 X26 X27 X28 X29 X30 X31
X59 X60 X61 X60 X61 X62 X63 X64 X65 X66 X67
X70 X75 X76 X71 X72 X73 X74 X75 X76
X88 X89 X90 X91 X92 X93 X94
X82 X83 X84 X85
X36 X37 X38 X39 X40 X41 X42 X43 X44 X45
X32 X33 X34 X35
X46 X47 X48 X49
X68 X69
X78
X95
X98 X99 X100
X112
X101 X102 X103 X104 X105 X106 X107
X121 X122 X123 X124 X125 X128 X129
X113 X114 X115 X116 X117 X118
X109 X110 X111
X119 X120
X87 X79 X80 X81 X86
X108 X97
1MACHINERY
BOOTH BOOTH
3
Exhibition AreaX
Conference Area
WC
WC
CATERING
OWEN MUMFORDWORKING LOUNGE
VETTER WORKING LOUNGE
DATWYLERWORKING LOUNGE
BESPAKWORKING LOUNGE
CATERING
ROCHE LOUNGE
H H
H H
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Halle:
EXPOXX MESSEBAU GmbHMesseplatz 1, Postfach 277, A-1021 WienT: +43 (0) 1 / 727 20-6101F: +43 (0) 1 / 720 19-6109info@expoxx.at - UID-Nr.: ATU 37633003
Messe:Auftragsnr.:
Kunde:
Standnr.:
M: Blatt:
Benennung:
Projektleiter:
Bearbeiter:
Alle Angebotsunterlagen bleiben Eigentum der Expoxx Messebau GmbH und können jederzeit zurückverlangt werden. Sie dürfen nicht vervielfältigt oder Dritten zugänglich gemacht werden.
Datum:
1:
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A0 PHACV
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POSTER SESSION
P DA Lo u n geY 4 8
COMMUNICATIONS CORNER
Y36 Y37
Y46 Y47 Y51
Y62
G2 G3 G4 G5
G8 G9 G10
Y30 Y31 Y33 Y34 Y35
Y41 Y42 Y44 Y45
INNOVATION GALLERY
NOBLE WORKING LOUNGE
CATE
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MAIN ENTRANCE
PDA REGISTRATION
WARDROBE
E X H I B I T I O N F L O O R P L A N
Machinery BoothLounge Area
Poster SessionCatering Area
Sponsor
Emergency Exit
Hydrant
Innovation Gallery
26 pda.org/EU-UPS2017
Plas-Tech Engineering Y36
Portal Instruments G5
Preh IMA Automation X109 + X110
Primequal Y31
PTI X24
rap.ID Particle Systems X88
Raumedic X08
Roche Roche Lounge
Rommelag X03
Rovi CM X36
Sartorius X70
Scherdel Medtec X128
SCHOTT X82 + X83
Schreiner Medipharm X107 + X118
SCS Specialty Coating Systems X05
Sensile X71 + X72
SHL Group X73 + X74 + X75
SiO2 Medical Products X64
SKAN X15 + X16 + X17
Smart Skin Technologies G2
Smithers Rapra & Smithers Pira X117
Sonceboz X78
SMC & Oval Medical Technologies X100 + X101
Steriline X39
Steris X18
Sumitomo Rubber Industries X59
TASI Test X91
Team Consulting X38
teamtechnik Maschinen & Anlagen X28 + X29
Terumo Booth 3
Topas X129
Transcoject X95
Toxikon X58
TriboGlide - IVEK X114
TTP The Technology Partnership X122
Vanrx Pharmasystems X33
Vetter X56 + X57 & G4
Weidmann Medical Technology AG X125
West X67 & G9
Whitehouse Labs X25
Wilco X15 +X16 + X17
YPSOMED X30 + X31
Yukon Medical X52
Zahoranski X02
Zebrasci Inc Y62
Zenius Y30
Zeon Y37
Zwick X22 + X23
I N N O VAT I O N G A L L ER Y Booth
altaviz G8
BioCorp G10
OMPI G3
Portal Instruments G5
Smart Skin Technologies G5
Vetter G4
West G9
100
X01
X50
X51
X52
X53
X55
X56
X57
X58
X02 X03 X04 X05 X06 X07 X08 X09 X11 X12 X13 X14 X15 X16 X17 X18
X21 X22 X23 X24 X25 X26 X27 X28 X29 X30 X31
X59 X60 X61 X60 X61 X62 X63 X64 X65 X66 X67
X70 X75 X76 X71 X72 X73 X74 X75 X76
X88 X89 X90 X91 X92 X93 X94
X82 X83 X84 X85
X36 X37 X38 X39 X40 X41 X42 X43 X44 X45
X32 X33 X34 X35
X46 X47 X48 X49
X68 X69
X78
X95
X98 X99 X100
X112
X101 X102 X103 X104 X105 X106 X107
X121 X122 X123 X124 X125 X128 X129
X113 X114 X115 X116 X117 X118
X109 X110 X111
X119 X120
X87 X79 X80 X81 X86
X108 X97
1MACHINERY
BOOTH BOOTH
3
Exhibition AreaX
Conference Area
WC
WC
CATERING
OWEN MUMFORDWORKING LOUNGE
VETTER WORKING LOUNGE
DATWYLERWORKING LOUNGE
BESPAKWORKING LOUNGE
CATERING
ROCHE LOUNGE
H H
H H
H
Schla
uchkaste
nfr
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Halle:
EXPOXX MESSEBAU GmbHMesseplatz 1, Postfach 277, A-1021 WienT: +43 (0) 1 / 727 20-6101F: +43 (0) 1 / 720 19-6109info@expoxx.at - UID-Nr.: ATU 37633003
Messe:Auftragsnr.:
Kunde:
Standnr.:
M: Blatt:
Benennung:
Projektleiter:
Bearbeiter:
Alle Angebotsunterlagen bleiben Eigentum der Expoxx Messebau GmbH und können jederzeit zurückverlangt werden. Sie dürfen nicht vervielfältigt oder Dritten zugänglich gemacht werden.
Datum:
1:
Plan-NrZng-Nr
001 2016M.Ebner 04.10.PDA Europe
A0 PHACV
X3
002
80
BAR
POSTER SESSION
P DA Lo u n geY 4 8
COMMUNICATIONS CORNER
Y36 Y37
Y46 Y47 Y51
Y62
G2 G3 G4 G5
G8 G9 G10
Y30 Y31 Y33 Y34 Y35
Y41 Y42 Y44 Y45
INNOVATION GALLERY
NOBLE WORKING LOUNGE
CATE
RIN
G
MAIN ENTRANCE
PDA REGISTRATION
WARDROBE
Access to Wireless InternetNetwork: PDAEU | Password: SHLGroup 27
That’s why we are committed to discovering and developing personalised medicines and targeted diagnostic tests to help people live better, longer lives.
People are different and so are diseases.
deep sciencerobust engineering
your solutionfrom simple and standalone, to complex and connected
ttp creates medical devices for its clients
TTP has been working with clients to design and develop medical devices for over 30 years. Our multi-disciplinary team has completed numerous parenteral
developments for pharma companies with our projects routinely covering front-end innovation and product definition through to industrialisation support.
From simple and standalone to complex and connected, come to our stand X122 to start the conversation.
ttp.com/engineeringoutcomes
IMPROVING PATIENTS‘ LIVES THROUGH OUR INNOVATIVE HEALTH CARE SOLUTIONS IS THE CORE OF OUR BUSINESS. BECAUSE WE CARE.
www.sealing.datwyler.pda.org/EU-UPS2017
The Complete Program for the Week
THE UNIVERSE OF PRE-FILLED SYRINGES AND INJECTION DEVICES
is available on the app
Create your own schedule, check the speaker profiles and prepare your visit to the exhibition from the palm of your hand!
Download the app from the App Store - search PDA UniverseYou can also access the desktop version at www.pda2017.com
2017UPS_app_FP_EU.indd 1 10.10.17 10:45
PDA Education offers courses that are developed and
taught by experts. They are uniquely targeted to professionals involved in the development and manufacturing of quality pharmaceutical and biopharmaceutical products.
Facts that Make a DifferenceUp-to date training courses and workshops taught by internatio-nally renowned instructors
Customized in-house training courses and workshops available
Wide range of training courses with hands-on experience to drive expertise, awareness, and innovation
9 November 2017Container Closure DevelopmentOne-Day Training Course
9–10 November 2017Container Closure Integrity Testing:Regulations, Test Methods, ApplicationTwo-Day Training Course
9–10 November 2017Rapid Microbiological MethodsTwo-Day Training Course
9–10 November 2017Best Practices and Points to Consider in Aseptic ProcessingTwo-Day Training Course
9–10 November 2017Development and Manufacturing of Pre-filled Syringes - A Hands-on Training CourseTwo-Day Training Course
9–10 November 2017Drug Delivery Sytems:Global Technical, Regulatory and Quality ChallengesTwo-Day Workshop
33pda.org/EU-UPS2017
34
ONE-DAY TRAINING COURSE
Container Closure DevelopmentOverviewThe course will give an overview on how to develop a container closure system for parenteral products. Starting with setting up of a product profile of the final product container, all aspects will be covered, like selection of materials, assessment of container closure systems, specification and documentation of components and entire systems. In addition, current hot topics such as glass delamination and container closure integrity testing will be discussed.
For all topics of the agenda presentations will be given. The participants are invited to add own experience, ask questions and offer issues to be discussed within the group and/or with the trainer. The intention is to work in an open workshop-like atmosphere.
Jörg Zürcher, Senior Scientist, BayerJörg Zürcher is a pharmacist by education. After his studies and PhD thesis at the Free University in Berlin, he started his career in the pharmaceutical industry 1990 with the former Schering AG. He is responsible for the development of container closure systems and application devices at Bayer HealthCare and has more than 25 years’ experience in that field. His current focus is the development of systems/devices for liquid and parenteral as well as ophthalmic dosage forms.
Learning Objectives: • Set-up of a target product profile of a container closure system
• Select appropriate container closure materials, components, and systems
• Apply the appropriate regulations and standards to container closure systems for parenteral formulations
• Prepare a development plan of a container closure systems from the early development until market phase
• Specify container closure system regarding technical aspects and regulatory requirements
• Understand compendial requirements and quality as well as technical standards regarding container closure components and systems
Who Should Attend: • Scientists in Drug Product Development
• Scientists/ Engineers in Packaging Development
• Regulatory Affairs Experts
pda.org/eu/CCD2017
TRAINING COURSE AGENDA
35
2 Nov 2017
Thursday, 9 November 2017 9:00 - 17:009:00 Welcome & Introduction
9:10 Setting up a Target Profile• Influence of formulation (small molecule, biological)• Use of product (patient, nurse, physician....)• Regulatory requirement
9:30 Material Selection• Ph.Eur. / USP / JP• Plastic vs. glass• Coating of material• Stopper material
10:30 Coffee Break
11:00 Selection of Packaging Solution
11:30 Assessment of Packaging Solutions – Development Data• Testing of injection vials/bottles and their respective components• Testing of pre-filled syringes (PFS) and their respective components• Extractables & Leachables (E&L) testing• Mechanical and functional testing
12:30 Lunch Break
13:30 Manufacturing of Packaging Solutions• Test runs• Process validation (risk assessment, critical parameters)• Container closure integrity (physical vs. microbiological testing – USP 1207)• Shipping test for PFS
14:00 Setting of Specifications• Technical drawings• Technical / quality specification• Testing standard, defect evaluation list• Examples
15:00 Coffee Break
15:30 Preparing the Submission• Relevant eCTD sections (drug substance and drug product)• Regulatory drawings• DMF for US
16:00 Routine and Release Testing• Certificates• Routine E&L testing• Reduced testing
16:15 Change Management• EU requirements
16:30 Wrap-up, Discussion, Q & A
17:00 End of Training Course
pda.org/eu/CCD2017
36
TWO-DAY TRAINING COURSE
Container Closure Integrity TestingOverviewThis workshop focuses on theoretical and practical fundamentals of various CCI testing technologies and provides a system-atic approach to applying these testing methods for CCI verification throughout drug product lifecycle. The Workshop will enable the participants to implement CCI testing strategies to ensure adequate drug product protection and be compliant with relevant regulatory and compendia requirements. In this Workshop, participants gain critical problem solving skills through:
• interactive discussions with a panel of cross-functional technical experts consisting of CCI testing laboratory experts, testing instrument suppliers/manufacturers, and pharmaceutical packaging development engineers
• hands-on testing training on the newest innovations and state-of-the-art instruments
• real-world case studies.
Lei Li, Ph.D, Associate Engineer Advisor Delivery and Device R&D, Eli Lilly
Lei Li currently serves as an engineer advisor at Delivery and Device R&D, Eli Lilly and Company. Lei has 9 years of experience in pharmaceutical and medical device industry, with focus on developing API and drug product packaging in support of clinical development and product commercialization, and establishing cold-chain dis-tribution for biologic products. His current responsibilities include developing package integrity verification profiles for Lilly’s diverse pipeline portfolio, developing and validating CCI testing methods, and supporting
commercial control strategy development for CCI verification throughout drug product and device life cycle. He is a frequent speaker at PDA conferences and author of peer-reviewed articles and book chapters on CCI test methods. Lei Li received his Ph. D. in Analytical Chemistry from West Virginia University; prior to joining Eli Lilly, he worked at GE Plastics as an analytical and material scientist.
Learning Objectives This workshop utilizes lectures, case studies, and interactive hands-on training on testing instruments to provide insight into the latest developments of Container Closure Integrity (CCI) Testing, with focus on achieving the following key objectives:
• Understanding up-to-date regulatory and pharmacopeia requirements on CCI.
• Defining CCI requirements for various container and drug product types using a risk-based approach.
• Explaining working principles of various CCI testing techniques and their practical applications, with focus on
deterministic methods such as tracer gas detection (e.g. helium leak detection), electrical conductivity and capacitance (HVLD), vacuum decay leak detection, laser-based gas headspace analysis, mass extraction leak test.
• Selecting and applying appropriate testing methods for both laboratory and in-process testing to formulate comprehensive package integrity verification profiles.
• Defining CCI testing method development and validation approach and best practices.
• Avoiding common issues and pitfalls in CCI testing applications
Who Should Attend• Parenteral drug packaging engineers and formulation scientists
• Laboratory scientific staff and managers
• Parenteral manufacturing staff
• Sterility Quality Assurance
• Regulatory affair scientists
• Pharmaceutical packaging component manufacturing staff
pda.org/eu/CCI2017
Presentation of Technology, Instruments Demo and Hands-on Training kindly supported by
ATC, Genesis Packaging Technology, Lighthouse, Pfeiffer Vacuum, pti, Wilco
TRAINING COURSE AGENDA
37
Jennifer Roark, B.S., Manager Chemistry & Container Testing, Eurofins Medical Device Testing
As Manager of Chemistry and Container Testing, Jennifer Roark oversees testing to support the container and package testing needs of both pharmaceutical and medical device clients. Her group specializes in various CCI testing technologies such as vacuum decay, high-voltage leak detection, FMS oxygen headspace, pressure decay, and dye immersion. She also supervises the physiochemical testing associated with the USP, EP, and JP General Chapters on plastics, elastomeric closures, glass, and container performance testing. Jennifer has more
than 22 years of analytical testing experience and serves as one of Eurofins’ leading subject matter experts for Extractables and Leachables Testing. She currently serves on ASTM Committee E55 on the Manufacture of Pharmaceutical and Biopharmaceutical Products, Subcommittee E55.04 General Biopharmaceutical Standards, leading the efforts to draft standard WK43945. Jennifer Roark has been involved with small molecule methods development and validation for over 12 years, and has co-published a series of articles on method validation.
Thursday, 9 November 2017 9:00 – 17:309:00 Welcome and Introduction
9:30 Opening Remarks:CCI Introduction, Regulatory Requirements, and Industry Trends
10:00 Introduction:Packaging Integrity Profile and CCI Testing • Introduction to container closure integrity• Testing requirement definition – risk based
approach• CCI Profile & Testing strategy development
10:20 Introduction to Group Exercise #1: Product life cycle testing and method selection
10:30 Coffee Break
11:00 CCI test methods: Fundamentals
11:30 CCI test methods: Overview
12:00 Lunch Break
13:00 Introduction to Group Exercise #2: Method Characteristics
13:30 Advanced CCI Testing Technologies and Seal Quality Testing Technologies1. Vacuum and pressure decay 2. Mass Extraction 3. Headspace analysis
15:00 Coffee Break
15:30 Advanced CCI Testing Technologies and Seal Quality Testing Technologies4. HVLD5. Tracer gas (helium leak detection) 7. Seal Integrity method example –
residual seal force
17:00 Group Exercise #1 & #2: Break Out Discussion/review of survey resultsDay-1 Summary Q&A
17:30 End of Day 1
Friday, 10 November 2017 9:00 – 16:309:00 Day-1 Review
9:10 Method Application Case Studies – Helium Leak Detection 1. HeLD for syringe testing (Eli Lilly)2. API Container Testing using HeLD
(Satorius Stedim)
10:00 Instrument Demo and Hands-on Training1. HVLD station2. Vacuum decay3. Headspace4. Helium leak detection5. Mass extraction & Residual Seal Force
10:30 Coffee Break
11:00 Instrument Demo and Hands-on Training (cont.)
12:30 Lunch Break
13:30 Group Exercise #2 Method Characteristics Review, Discussion, and Q&A
13:50 Development and Validation of Integrity Test Methods• Method development best practices• Method validation strategy• Pitfalls and solutions
14:30 Coffee Break
15:00 Approaches to CCI Testing Method Selection• Method selection considerations• Class discussion - examples
15:30 Group Exercise #1 Method Selection Review, Discussion, Q&A
16:00 Course Summary
16:30 End of Workshop
pda.org/eu/CCI2017
38
TWO-DAY TRAINING COURSE
Rapid Microbiological Methods
Learning Objectives: • Discuss the benefits of alternative and RMM technologies as compared with classical microbiological
methods• Describe the scientific basis for a variety of technologies that may be qualified as alternative methods
to classical microbiology procedures; explore case studies and actual workflows for dozens of com-mercially-available technologies
• Explain the regulatory environment, guidance, policies and expectations for validation, submissions and implementation from FDA, EMA, TGA, PMDA, ISO and WHO; understand when and how to change acceptance levels
• Develop business plans and return on investment justifications, follow an actual case study in signifi-cant cost savings and cost avoidances by implementing a RMM for environmental monitoring
• Apply industry best practices for validating these new technologies in order to demonstrate that the methods are acceptable for their intended use via IQ, OQ and PQ qualification strategies; understand the differences between PDA TR 33, the new USP 1223 chapter and the proposed Ph. Eur. Chapter 5.1.6
OverviewThis comprehensive course is designed to provide an intensive review of currently available rapid microbiological method (RMM) technologies, validation strategies, applications, regulatory expec-tations, financial justification models and implementation plans. Taught by one of the industry’s global leaders in rapid methods, the attendee will be immersed in discussions that will provide a meaningful and understandable roadmap for how to evaluate RMMs and employ them in their own laboratory and manufacturing areas.
Who Should Attend: • Departments: Microbiology, Compliance, Engineering, Manufacturing, QA/QC, CMC Documentation,
Regulatory Affairs, Research and Development, Validation, QP• Level of Expertise: Senior Management, Scientists/Technicians• Job Function: Supervisor, Researcher, Analyst, Operative Personnel
Michael J. Miller, PhD, President, Microbiology Consultants, President
Dr. Michael J. Miller is an internationally recognized microbiologist and subject matter expert in pharmaceu-tical microbiology and the design, validation and implementation of rapid microbiological methods. He is currently the President of Microbiology Consultants, LLC. In this role, he is responsible for providing scientific, quality, regulatory and business solutions for the pharmaceutical industry and suppliers of new microbiology technologies. Michael currently serves on a number of PDA’s program and publication committees and ad-
visory boards, and is co-chairing the revision of PDA Technical Report #33: Evaluation, Validation and Implementation of New Microbiological Testing Methods. Dr. Miller holds a PhD in Microbiology and Biochemistry from Georgia State University (GSU), a BA in Anthropology and Sociology from Hobart College, and is currently an adjunct professor at GSU.
pda.org/eu/RMM2017
TRAINING COURSE AGENDA
39
2 Nov 2017
Thursday, 9 November 2017 9:00 – 18:00
9:00 Welcome
9:15 Introduction to RMMs, Applications, Implementation Strategies, Opportunities
Growth-based RMMs; Scientific Principles, Applications and Case Studies
10:30 Coffee Break
11:00 Regulatory Policies and Expectations: FDA, EMA, TGA, PMDA, ISO and WHO
12:30 Lunch Break
13:30 Cellular-component Based RMMs; Scientific Principles, Applications and Case Studies
Viability-based RMMs; Scientific Principles, Applications and Case Studies
15:30 Coffee Break
16:00 Spectroscopic-based RMMs; Scientific Principles, Applications and Case Studies
Genetic and Gene Amplification-based RMMs Part 1; Scientific Principles, Applications and Case Studies
18:00 End of Day 1
Friday, 10 November 2017 9:00 – 16:30
9:00 Genetic and Gene Amplification-based RMMs Part 2; Scientific Principles, Applications and Case Studies
10:30 Coffee Break
11:00 MEM-based RMMs; The Future of Alternative Technologies
Validation of RMMs Part 1; Due Diligence Activities, Vendor Expectations, IQ, OQ and PQ Strategies, Validation Acceptance Criteria, Use of Statistics
12:30 Lunch Break
13:30 Validation of RMMs Part 2; Equivalence, Method Suitability, Comparison of PDA TR33, the New USP 1223 and the Proposed Ph. Eur. 5.1.6
A Case Study on Conducting Economic Assessments and Return-on-Investment (ROI) Calculations
15:00 Coffee Break
15:30 References, On-line Resources and Final Remarks
16:30 End of Training Course
pda.org/eu/RMM2017
40
TWO-DAY TRAINING COURSE
pda.org//bestpractices-aseptic
Best Practices and Points to Consider in Aseptic Processing
Guenther Gapp, PhD, Independent Consultant, Gapp Quality GmbH
For the past five years, the microbiologist Guenther Gapp has been working as an independent consultant with different clients and contractors worldwide. In many projects he has been engaged as “Aseptic Process-ing Expert” for projects worldwide in remediation of companies cited with Warning Letters, audits and other assignments. In his previous career, Guenther spent 20 years in the pharmaceutical industry as Head of QA/QC Microbiology and as Sterility Assurance Expert and Troubleshooter. During this period, he gained in-depth
experience in aseptic processing key elements. He has been a subject matter expert in more than 20 FDA audits. Guenther also created a new sterile risk assessment tool to identify and reduce the microbial contamination and compliance risk of sterile products, and this method is now in use worldwide. The publication of this Risk Assessment tool won him the 2011 PDA Journal of Pharmaceutical Science and Technology Award. Since 2017 he is also member of PDA Task Force groups regarding Aseptic Processing Industry Survey and the EU Annex 1 revision, and member of the PDA Science Advisory Board. A brand new initiative is to assess and improve the current hygiene conditions and aseptic working practices in local Austrian hospitals, aiming to reduce the threatening “nosocomial infection rates” of patients.
Overview
Aim of this training course is to facilitate a deeper understanding and provide insights into the Aseptic Pro-cessing environment, and to go beyond what is commonly covered in books on that subject. A practical and highly interactive approach will enable participants to get actively involved, discussing guidelines and Warning Letters in addition to sharing perspectives and solutions to issues found in everyday job situations.
A kaleidoscope of hot topics such as Best Practices and Case Studies from different areas of Aseptic Process-ing, Sterile Production facilities, QA/ QC Microbiology Control, Shop Floor Mentoring and Oversight will be addressed. Training and Motivation of staff, use of Risk Assessments and Quality Culture are further relevant aspects.
Lively interactions will make this a valuable learning experience for all.
Who Should Attend: Personnel involved in Aseptic Processing from sterile production departments such as:• Production Management and Shop Floor
Supervisors• QA and QC Microbiologists• Qualified Persons• Personnel from technical department
A basic understanding of Aseptic Processing is a prerequisite.
Learning Objectives: • Gain deeper knowledge and insights into specific topics like steriliza-
tion, training and motivation of shop-floor staff, correct aseptic work-ing practices, media fill worst case criteria, effective environmental monitoring programs, good cleaning & disinfection practices, etc.
• Understand key requirements and challenges in parenteral production• Understand the importance of a good quality culture within a company• Apply the executed and presented case studies and team exercises in
her/his daily job • Get answers and interpretations about - potentially - unresolved
questions and problems• Gain confidence for audits
TRAINING COURSE AGENDA
41pda.org//bestpractices-aseptic
2 Nov 2017
Thursday, 9 November 2017 9:00 – 18:00
9:00 Welcome
9:30 Introductional Test about Selected Hot Topics in Aseptic Processing - Discussion of Answers
10:30 Coffee Break
11:00 Importance of a Good Quality Culture in Aseptic Processing – What May Go Wrong
11:30 Important Aspects of Sterilization, Cleaning and Disinfection, Gowning Procedures
12:30 Lunch Break
13:30 Aspects of Clean Room Concepts and Good Aseptic Working Practices - Conventional Filling Lines, RABS Systems and Isolators
14:30 Team Exercise: Preparing a New Concept for Start-Up of an Aseptic Filling Line
15:30 Coffee Break
16:00 Hot Topics in Pharmaceutical Water Systems and Best Control Practices
16:30 Effective Oversight at the shop-floor, Good Training Methods
18:00 End of Day 1
Friday, 10 November 2017 9:00 – 16:30
09:00 Guidance How to Execute in Media Fills and Process Simulations (Definition of Worst Case Criteria), Sterile Active Product Ingredients, PDA TR 22
10:00 EU Annex 1: What Are the Changes
10:30 Coffee Break
11:00 Important Aspects in Environmental Monitoring and Team Exercise, PDA TR 30
12:30 Lunch Break
13:30 Applications of Risk Assessments for Microbial Contamination Control and for Supporting Decisions in Case of EM-Deviations (HAZOP and FMEA)
14:30 Selection of Case Studies About Microbiological Deviations, Related Root Causes and CAPAs in Aseptic Processing
15:30 Coffee Break
16:00 Summary & Discussion of Open Questions
16:30 End of Course
42
TWO-DAY TRAINING COURSE
pda.org/eu/dev_syringe
Development and Manufacturing of Pre-filled Syringes A Hands-on Training Course
Moderator:Egmont Semmler, PhD, Director Research & Development, Groninger
Speaker:Erik Berndt, Industry Manager Medical/Pharmaceutical, ZwickAlessandro Morandotti, Product Manager Syringes, Nuova OmpiChrista Jansen-Otten, Director Marketing PFS Europa, WestHorst Koller, CEO, HK-Packaging ConsultingOliver Valet, PhD, Managing Director, rap.IDBernd Zeiss, Manager Technical Support Medical Systems, Gerresheimer
Overview
This two-day interactive course will provide an overview of relevant practical aspects and trends of develop-ing and processing of bulk and pre-sterilized primary packaging systems, especially pre-filled syringes. It will also address relevant regulatory aspects and topics such as container handling in the filling process, glass defects, particulates and visual inspection and the relevant test methods. In addition to theoretical insights, participants will have the opportunity to use equipment and perform testing by themselves in hands-on sessions. Processing steps, inspection and quality aspects will be demonstrated using state-of-the-art tech-
nology. There are discussion and Q&A sessions with real case examples.
Who Should Attend This course offers valuable insights and updates for anyone involved in development, produc-tion, quality, auditing, project management and purchasing
Learning ObjectivesUpon end of this course you know about and have an overview of:• Processes involved in primary packaging manufacturing, filling
and processing• Test methods for development, IPCs and quality testing • Relevant machines and test equipmentsLearn about the complexity and interdependencies of the develop-ment and manufacturing of Pre-filled Syringes and get an under-standing what to consider for a successful project.
Faculty
TRAINING COURSE AGENDA
43pda.org/eu/dev_syringe
2 Nov 2017
Thursday, 9 November 2017 9:00 – 18:009:00 Welcome Egmont Semmler,
Groninger
9:05 Advantages of Pre-filled Syringes and Market Trends in Primary Packaging• Properties and advantages of Pre-filled Syringes• Market overview of the injectables markets• Trends in parenteral applications
Christa Jansen-Otten, West
9:30 Development and Regulatory Aspects of Primary Packaging• The relevant guidelines• Vial- syringe life cycle management considerations
Horst Koller, HK Packaging
10:00 The Complete Manufacturing Process of Pre-filled Syringes• Washing, endotoxin testing• Siliconization, types of silicon oils and application• Sterilization and silicon oil fixing• Ready to fill glass syringe handling
Egmont Semmler, Groninger
10:30 Coffee Break
11:00 The Complete Manufacturing Process of Pre-filled Syringes (cont.)• Filling methods, pumps• Stoppering methods• Selection criteria for filling and stoppering
Egmont Semmler, Groninger
11:30 Q&A on Manufacturing
12:00 Lunch Break
13:00 Testing of Pre-filled Syringes (Siliconization, Visual Inspection)• Silicon oil layer measurements• Visual inspection, criteria
Oliver Valet, rap.ID
13:30 Testing of Pre-filled Syringes (ISO 11040-4 and more)• The ISO standards• Flange and Luer cone
breakage resistance• Glide force tests
• Needle penetration test• Pull-off forces on tip caps• Test equipments• Luer-lock tests
Erik Berndt, Zwick
14:00 Q&A on Testing
14:30 Coffee Break
15:00 Interactive Hands-on Session• Manufacturing machines: Siliconization, filling procedures, stoppering methods• Testing equipment: Silicon layer, particle identification, glide force and methods
acc. to ISO 11040-4• Container closure integrity testing
17:00 Q&A, Discussion and Real Case Examples• What can go wrong and how to avoid or fix it
18:00 End of Day 1
44 pda.org/eu/dev_syringe
TRAINING COURSE AGENDA
Friday, 10 November 2017 9:00 – 17:009:00 Glass Syringes
• Manufacturing of glass• Glass forming• Physical and chemical properties• Bulk and Ready to fill concepts• Quality aspects
Alessandro Morandotti, Nuova Ompi
9:45 Polymer Syringes• Materials • Physical and chemical properties• Processing and quality
Bernd Zeiss, Gerresheimer
10:15 Q&A
10:30 Coffee Break
11:00 Elastomeric Closures for Pre-filled Syringes and Cartridges• Manufacturing of elastomers • Physical and chemical properties• Processing: washing / siliconization • Quality aspects / coated and uncoated /bulk and ready to use
Christa Jansen-Otten, West
12:00 Q&A
12:30 Lunch Break
13:30 Assembly of Syringes into Devices• ISO Standards 11608• Tests of the primary containers• Tests on the assembled primary container-device• Equipment and test procedures
Erik Berndt, Zwick
14:15 Q&A
14:30 Coffee Break – Parallel to next Agenda Topic
14:30 Interactive Hands-on Session, small groups:• Polymer and glass syringes• Elastomer types and selection criteria• Devices• Test Methods
16:00 Q & A, Discussion with Real Life Examples
17:00 End of Course
Learn more at bd.com/Discover-BD1
BD Libertas™ wearable injector, BD Libertas™ wearable injector with Smart option and BD Intevia™ autoinjector are products in development; some statements made are subject to a variety of risks and uncertainty.
© 2017 BD. BD and the BD Logo are trademarks of Becton, Dickinson and Company. BDPS24234
FOR BETTER TREATMENT OF CHRONIC DISEASES. Across the healthcare continuum, BD is the industry leader in parenteral delivery devices that help health systems treat chronic diseases. We not only continually advance clinically proven, prefillable drug delivery systems, we do so with a vision to help healthcare providers gain better understanding of how patients self-inject their chronic disease therapies outside the healthcare setting. This is why we partner with leading pharmaceutical and biotech companies worldwide to develop digitally-connected self-injection devices—including wearable injectors and autoinjectors— to capture valuable data that can be shared with caregivers. Discover how BD brings new ideas and solutions to customers, and new ways to help patients be healthy and safe. Discover the new BD.
BD Libertas™ wearable injector with Smart option
BD Libertas™ wearable injector BD Intevia™ autoinjector
Learn more at bd.com/Discover-BD1
BD Libertas™ wearable injector, BD Libertas™ wearable injector with Smart option and BD Intevia™ autoinjector are products in development; some statements made are subject to a variety of risks and uncertainty.
© 2017 BD. BD and the BD Logo are trademarks of Becton, Dickinson and Company. BDPS24234
FOR BETTER TREATMENT OF CHRONIC DISEASES. Across the healthcare continuum, BD is the industry leader in parenteral delivery devices that help health systems treat chronic diseases. We not only continually advance clinically proven, prefillable drug delivery systems, we do so with a vision to help healthcare providers gain better understanding of how patients self-inject their chronic disease therapies outside the healthcare setting. This is why we partner with leading pharmaceutical and biotech companies worldwide to develop digitally-connected self-injection devices—including wearable injectors and autoinjectors— to capture valuable data that can be shared with caregivers. Discover how BD brings new ideas and solutions to customers, and new ways to help patients be healthy and safe. Discover the new BD.
BD Libertas™ wearable injector with Smart option
BD Libertas™ wearable injector BD Intevia™ autoinjector
46 pda.org/EU-UPS2017
TWO-DAY WORKSHOP
Drug Delivery Systems: Global Technical, Regulatory and Quality Challenges
Overview
The FDA started to address Drug Delivery Systems as combination products almost 20 years ago and have more recently instituted a growing number of unique ways to regulate the development, registration and control of these products. To make issues more complicated, there are an increasing number of regions that are also starting to treat these products differently. One of these examples is the upcoming Medical Device Regulation (MDR) to be considered also for Drug Device Combinations in Europe. Independent of the reg-ulations, the number, scope and complexity of these products is expanding exponentially. This workshop will provide attendees with insight into the challenges, and potential solutions to dealing with the require-ments and regulations related to the development, registration and control of Drug Delivery Systems. The workshop will include speakers from regulators and industry and allow interactive audience participation with panels of experts on each issue to provide a forum for information and discussion on navigating the challenges presented by these products.
Who Should Attend: This course will be geared towards in-dividuals who are responsible for, have input into, oversight for or actively participate on, drug delivery product development teams. This includes the following practitioners, managers and directors in Medical Device, Pharma-ceutical or consulting companies:
• Project Management• Marketing• Regulatory Affairs• Quality Assurance• Clinical Affairs • Product Safety• Human Factors Engineering• Device Development Engineering
• Quality Engineering• Formulation • Testing laboratories• Design Verification Department
Lee Leichter, P/L BiomedicalManfred Maeder, Novartis
Workshop Leader
47pda.org/EU-UPS2017
WORKSHOP AGENDA
Lee H. Leichter, RAC, MBA, President P/L Biomedical
Lee Leichter has over 40 years’ experience in the health care industry, providing direct, hands-on assistance to domestic and inter-national Pharmaceutical, Biotechnology and Medical Device companies for the last 20. Projects have encompassed a multitude of business, technical, regulatory and quality issues, primarily related to drug delivery and combination products for marketing in the USA, Europe and Canada. He has worked with large multi-national companies, as well as start-ups, successfully navigating the challenges posed during the development, testing and marketing approval of products that merge pharmaceutical substances
with high-tech device systems. Serving as an independent expert on ISO technical committees for Injection and respiratory products, infusion pumps, needles and catheters, and AAMI Injection and Infusion Devices and Human Factors committees, he assists in establishing international standards for safety and performance of these products. He initiated, and leads the ISO Workgroup developing a standard for On Body Delivery Systems (OBDS). His education includes a Bachelor’s degree from the State University of New York at Stony Brook and an MBA with Honors from Florida Gulf Coast Univer-sity. Lee is currently certified in USA and EU Regulatory Affairs from RAPS and was certified as a Quality Engineer from ASQ.
2 Nov 2017
Thursday, 9 November 2017 9:00 – 17:009:00 Welcome and Introduction Manfred Maeder,
NovartisLee Leichter, P/L Biomedical
Current Challenges and Changes Due to New Regulatory Expectations
9:15 Recent and Upcoming Changes and Challenges in the EU Manfred Maeder, Novartis
9:45 Recent and Upcoming Changes and Challenges in the USA Lee Leichter, P/L Biomedical
10:15 FDA 21 CFR 4 cGMP Requirements - Impact on Drug Delivery Systems Viky Verna, confinis
10:45 Coffee Break
Regulatory Considerations – How to Submit a Drug Device Combination Worldwide?
11:15 Global Perspective on Drug Delivery Submissions - Regulatory Chin-Wei Soo, Genentech
12:00 Regulatory Considerations for Drug Device Combinations Nick Lee, HPRA - Irish Agency
12:45 Lunch Break
13:45 Notified Body Position – How Will this be Implemented? Giovanni DiRienzo, TUEV Sued
14:30 Panel Discussion
15:00 Coffee Break
When There are Two Separate Products, How Do the Companies Coordinate? Labeling/Promotion/Distribution/Complaints/PMS/Changes
15:30 Successful Drug Delivery Requires an Integrated Approach Tibor Hlobik, West
16:15 Panel Discussion
16:30 Q&A
17:00 End of Day 1
48 pda.org/EU-UPS2017
WORKSHOP AGENDA
Friday, 10 November 2017 9:00 - 16:00Technical Considerations During Drug Device Combination Products Development
9:00 How Can Pharma Benefit from a Well-defined and Robust Delivery Device Platform
Thomas Schoenknecht, SHL
9:30 Platform Technology Stephan Affolter, Ypsomed
10:00 Coffee Break
Human Factors Considerations
10:30 Product Development and Human Factors Considerations for NDAs and BLAs: Navigating the Halls of FDA/CDER
Irene Chan, FDA
11:00 HFE regulation implementation: Industry perspective Muriel Didier, Novartis
11:30 Panel Discussion
12:00 Lunch Break
Life Cycle Management Activities of Drug Device Combinations [eg. Changes, PMS, …..]
13:00 Company Position – ISO Standard – Risk Based Approach to Combination Product Change Management
Suzette Roan, Biogen
13:30 Risk Management – Activities During Development and Life Cycle Management Alice Maden, BD
14:00 Discussion
14:15 Coffee Break
14:45 Using Risk Management to Establish Product Risk Benefit as Part of the Development Process per ISO 14971 , ICHQ9 and Future GMP Annex 1
Horst Koller, HK Packaging
15:15 Processes/systems for Risk Based Decisions for Specification etc. Lee Leichter, P/L Biomedical
15:45 Discussion
16:00 End of Workshop
Manfred Maeder, PhD, Head Device Development & Commercialization of BTDM, Novartis
Since 2015 Manfred Maeder is Head Device Development & Commercialization of BTDM (Biologics Technical Development and Manufacturing) at Novartis. Before that he held the position Head of Global Compliance & Audit for Devices & Combination Products overseeing all Alcon, Pharma, and Sandoz sites producing this type of products and Global QA Head of Technical Re-search and Development starting in 2011. Prior to this position, he was Senior VP of Quality Management & Regulatory Affairs at Ypsomed. Previously, he was responsible for Quality Assurance Management at Sanofi-Aventis for the Frankfurt Injectables site.
Before then, being based in Kansas City/ US, he had a global responsibility for Quality and Regulatory for one of the Aventis Blockbuster products. Prior to that, he held several positions in QA and QC. By training he is pharmacist and holds a doctorate in pharmaceutical analytics and statistics by the University of Wuerzburg/ Germany.
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CO NTAC T I N FO R M ATI O NConference InquiriesMelanie DeckerDirector Events & Exhibitionsdecker@pda.org
Conference Program InquiriesSylvia Beckerprograms-europe@pda.org
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How to find the Venue:
INFORMATION
53pda.org/EU-UPS2017
The Universe of Pre-filled Syringes & Injection Devices
Your registration is only complete upon filling in and submitting both pages of this form.
1 Registration
Group Registration Discount Register 5 colleagues for the conference at the same time and receive the 5th registration free. For more information on group discounts please contact Antje Petzholdt at petzholdt@pda.org. Other discount cannot be applied.
The fee includes course documentation as well as mid-session refreshments and lunch. Excellent networking opportunities with snacks and drinks will be given. The fee does not include the hotel accommodation. PDA Europe has secured a limited number of rooms at a special group rate.
All registrations received after 3 November will be subject to a 200€ late fee
All fees given in Euro, excluding VAT (20%)
LATE REGISTRATION FEE:
Registration Form Page 1
7–8 November 2017 | Vienna | Austria
** Conference Registration Fee includes a one-year PDA membership if no further special discount is granted. If you do not wish to join PDA and receive the benefits of membership, please check here (same rate applies).
Conference The Universe of Pre-filled Syringes & Injection DevicesPDA Member Nonmember Regulatory, Academic
7–8 November * Regulatory Early Bird 850 € 1995 2295** 950*
Pre-Conference Workshop Innovative Drug Delivery Sytems / Combination Products6 November All Participants 795
Pre-Conference Workshop Impact of Pre-filled Syringe Packaging Components for Biopharmaceuticals 6 November All Participants 795
Pre-Conference Workshop Connected Health & Drug Delivery6 November All Participants 795
One-Day Training Course Container Closure Development 9 November All Participants 845
Two-Day Training Course Best Practices and Points to Consider in Aseptic Processing 9–10 November All Participants 1495
Two-Day Training Course Rapid Microbiological Methods 9–10 November All Participants 1495
Two-Day Training Course Container Closure Integrity Testing9–10 November All Participants 1495
Two-Day Training Course Development and Manufacturing of Pre-filled Syringes9–10 November All Participants 1495
Two-Day Workshop Drug Delivery Sytems: Global Technical, Regulatory and Quality Challenges9–10 November All Participants 1495
Please mark here if your company is an exhibitor to this event and you will receive the conference ticket at the special price of 1345 € per ticket. No further discounts are applicable with this option (as PDA Membership discount or Group Ticket discount).
Discount for Exhibiting Companies
54 pda.org/EU-UPS2017
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pda.org/EU-UPS2017 55
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• All registrations which will involve visa matters will have to be submitted to PDA EU four weeks prior to the start of the event at the latest. For later registrations, PDA Europe will be unable to assist participants in any visa affairs.
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CONFIRMATION: Transmitting your filled-in registration form constitutes a binding application for the specific event. PDA Europe will send you a confirmation including payment details. A legally binding contract is concluded once PDA Europe has sent a written invoice by mail to you. A letter of confirmation will be sent to you within one week once payment has been received. You must have this written confirmation to be considered enrolled for this PDA event. PDA Europe reserves the right to deny access to anyone unable to provide written confirmation that all dues have been fully settled. SUBSTITUTIONS: If you are unable to attend, substitutions are welcome and can be made at any time, including on site at the prevailing rate. If you are registering as a substitute attendee, please indicate this on the registration form. Changes are free of charge until 2 weeks prior to the start of the event. After this two-weeks period, there will be a charge of € 100 per name change. REFUNDS: Refund requests must be sent to PDA Europe. If your written request is received on or before 10 September 2017, you will receive a full refund minus a 150 € excl. VAT handling fee. After that time, no refund or credit requests will be approved. If you are an unpaid registrant and do not attend the event, you are responsible for paying the registration fee. On-site registrants are not guaranteed to receive conference materials until all advanced registered attendees receive them. PDA Europe works PCI-Compliant. EVENT CANCELLATION: PDA reserves the right to modify the material or speakers/instructors without notice, or to cancel an event. If an event must be canceled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact PDA at info-europe@pda.org or fax to +49 30 4365508-66. DOCUMENTATION: With your signature you give complete picture usage right to PDA and allow to film your exhibition space and intervention in the event, including the recording of your presentation for video purposes (with your slides, voice and image). This right extends also to the use of the resulting images in film documentation for webinars and similar items produced by PDA.
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Events with additional Education Program. More information – europe.pda.org
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General InformationPDA Europe gGmbHAm Borsigturm 60 13507 Berlin, GermanyTel: +49 30 4365508-0Fax: +49 30 4365508-66info-europe@pda.org
Connecting People, Science and Regulation®
2 0 1 7 P D A E U R O P E C O N F E R E N C E S 7-8 November The Universe of Pre-filled Syringes and Injection Devices Vienna, Austria
21-22 November Outsourcing & Contract Manufacturing Munich, Germany
2 0 1 8 P D A E U R O P E C O N F E R E N C E S 26 February26 February27-28 February
IG Meeting Pre-filled Syringes IG Meeting Parenteral PackagingParenteral Packaging
IGIG
Rome, Italy
24-25 April Vaccines Location TBC
15-16 May Virus Forum Florence, Italy
29-30 May Pharmacopoeia Conference Vienna, Austria
5-6 June Advanced Therapy Medicinal Products Amsterdam, The Netherlands
25 June25 June25 June26-27 June
IG Meeting Visual InspectionIG Meeting Freeze DryingIG Meeting Quality Systems3rd PDA Europe Annual Meeting
IGIGIG
Berlin, Germany
15-16 October Pharmaceutical Microbiology Berlin, Germany
23-24 October Visual Inspection Forum Berlin, Germany
6-7 November Pharmaceutical Freeze Drying Technology Location TBC
6-7 November 11th Workshop on Monoclonal Antibodies Location TBC
27-28 November Outsourcing & Contract Manufacturing Location TBC
27-28 November Pharmaceutical Cold Chain & Supply Chain Logistics Location TBC
Subject to change For latest info: europe.pda.org Shortlist 2 Nov 2017