Weitere Informationen zur Veranstaltung und zur Anmeldung erhalten Sie auf der Webseite http://www.ectd-congress.com oder persönlich bei unserem Events Team unter Tel: +49 (0) 30 20 91 34 28 oder per Email an: [email protected] Besuchen Sie auch unsere Webseite: http://www.iqpc.de
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Researched and developed by • Meet key EU regulators and gain insights into the adoption and requirements of eCTD to get your submission accepted as quickly as possible • Hear best practices on the successful handling of eCTD lifecycle management and document strategies to avoid costly pitfalls • Profit from first experiences of the New EU Variation Regulation concerning implementation deadlines and consequences • Learn how to adopt eCTD in small and medium-sized companies to make sure that you will choose the right strategy for your company • Hear best solutions on handling Product Information Management (PIM) and gain insights into the impact on eCTD submissions to ensure the best product migration process Leading companies and institutions will present case studies and solutions on efficient eCTd Submissions: Bayer Schering Pharma AG, Germany Merck Serono, Germany Danish Medicines Agency, Denmark College ter Beoordeling van Geneesmiddelen, CBG-MEB, Netherlands Agence Française de Sécurité Sanitaire des Produits de Santé, Afssaps, France División Tecnologías Información, Agencia Española de Medicamentos y Productos Sanitarios, AEMPS, Spain Gebro Pharma GmbH, Austria PARI Pharma GmbH, Germany German Medicines Manufacturers Association, BAH, Germany Federal Institut for Drugs and Medical Devices, BfArM, Germany Abbott Products GmbH, Germany Schering Plough Netherlands B.V., Netherlands Astellas Pharma Europe R&D, Netherlands INTERACTIVE WORKSHOP DAY | Wednesday, 2 nd February 2011 A Implementation of eCTD in sme (small and medium-sized companies) B eCTD Technical Validation Criteria - How to get eCTDs through technical validation at agencies C Successfully managing eCTD Lifecycles D PIM & eCTD Efficient eCTD Submissions 2011 31 st January – 2 nd February 2011 | Meliá Hotel, Berlin 3 rd Congress EU- Regulators - New EU Variations Regulation – Lifecycle Management – PIM Dr. Adam Aparicio, Head of Global Regulatory Operations, Merck Serono, Germany Elke Schydlo, Technical Services, Global Regulatory Affairs Manager, Submission Services Hannover, Abbott Products GmbH, Germany Rob De Haan, Deputy Director MEB, College ter Beoordeling van Geneesmiddelen, Netherlands Miguel BLEY, Head of European Affairs, Agence Française de Sécurité Sanitaire des Produits de Santé (Afssaps), France Benefit from contributors such as: To Register | T +49 (0)30 20 91 33 30 | F +49 (0)30 20 91 33 12 | E [email protected]| www.ectd-kongress.de/MM Hear key EU-Regulators on how to get eCTDs through technical validation at agencies SAVE up to € 290,- if you book by the 12 th November 2010! Medienpartner Supported by Sponsor
Transcript
Researched and developed by
• Meet key EU regulators and gain insights into the adoption and requirements of eCTD to get
your submission accepted as quickly as possible
• Hear best practices on the successful handling of eCTD lifecycle management and document
strategies to avoid costly pitfalls
• Profit from first experiences of the New EU Variation Regulation concerning implementation
deadlines and consequences
• Learn how to adopt eCTD in small and medium-sized companies to make sure that you will
choose the right strategy for your company
• Hear best solutions on handling Product Information Management (PIM) and gain insights into the
impact on eCTD submissions to ensure the best product migration process
Leading companies and institutions will
present case studies and solutions on efficient
eCTd Submissions:
Bayer Schering Pharma AG, Germany
Merck Serono, Germany
Danish Medicines Agency, Denmark
College ter Beoordeling van
Geneesmiddelen, CBG-MEB, Netherlands
Agence Française de Sécurité Sanitaire des
Produits de Santé, Afssaps, France
División Tecnologías Información, Agencia
Española de Medicamentos y Productos
Sanitarios, AEMPS, Spain
Gebro Pharma GmbH, Austria
PARI Pharma GmbH, Germany
German Medicines Manufacturers
Association, BAH, Germany
Federal Institut for Drugs and Medical
Devices, BfArM, Germany
Abbott Products GmbH, Germany
Schering Plough Netherlands B.V.,
Netherlands
Astellas Pharma Europe R&D, Netherlands
INTERACTIVE WORkSHOP DAy | Wednesday, 2nd February 2011
A Implementation of eCTD in sme (small and medium-sized companies)
B eCTD Technical Validation Criteria - How to get eCTDs through technical validation
at agencies
C Successfully managing eCTD Lifecycles
D PIM & eCTD
Efficient eCTDSubmissions 201131st January – 2nd February 2011 | Meliá Hotel, Berlin
3rd Congress
EU- Regulators - New EU Variations Regulation – Lifecycle Management – PIM
Dr. Adam Aparicio, Head of Global Regulatory Operations, Merck Serono, Germany
Elke Schydlo, Technical Services, Global Regulatory AffairsManager, Submission Services Hannover, Abbott Products GmbH, Germany
Rob De Haan, Deputy Director MEB, College ter Beoordeling van
Geneesmiddelen, Netherlands
Miguel BLEy, Head of European Affairs, Agence Française de Sécurité Sanitaire
des Produits de Santé (Afssaps), France
Benefit from contributors such as:
To Register | T +49 (0)30 20 91 33 30 | F +49 (0)30 20 91 33 12 | E [email protected] | www.ectd-kongress.de/MM
please visit our websitewww.ectd-kongress.de/MM or con-tact Hannah Schädler orMark Reichmann via email [email protected].
Dear colleagues,
Submission documents have traditionally been handed in to agencies on paper, meanwhile electronic systems
are used for building and managing these documents. Nowadays electronic-only submission (eCTD) is, how-
ever, becoming ever more mandatory. For example, since 2009 electronic-only submission has been mandato-
ry at the EMA in England. eCTD could constitute a huge advantage for pharma industries because the submis-
sion time can be substantially reduced, allowing for a quicker release of products onto the market. However,
the implementation and handling of eCTD are problematic due to different standards at each European
agency. The implementation of eCTD in the company also means a change of the workflow and a high
demand on archiving and managing the electronic documents (lifecycle management). Furthermore the
New EU Variations Regulation (since January 2010) denotes modification when it comes to reporting varia-
tions to the agency.
Discuss the challenges of efficient eCTD submissions at our
3rd Congress
Efficient eCTD Submissions EU Regulators – New EU Variations Regulation – Lifecycle Management – PIM
31.01.-02.02.2011 | Meliá Hotel, Berlin
Find out how to:
• get eCTDs through technical validation at agencies
• prepare PIM submissions
• implement eCTD in small and medium-sized companies
Join our expert panel, save your place and book today!
We look forward to welcoming you to our 3rd congress Efficient eCTD Submissions in Berlin!
Kind Regards,
Monica Wick
Project Manager
Sponsorship
We have a variety of packagesavailable to suit your requirements. For all Sponsorship and Exhibitionopportunities call Ralph Grundmann: +49 (0) 30 20 91 32 75 or email [email protected].
Who will you meet?
• Regulatory Affairs• Global Regulatory Operations• Documentation Management• Submission Management• Regulatory Lifecycle Management• IT Regulatory Support
31st January – 2nd February 2011 | Meliá Hotel, Berlin
Efficient eCTD Submissions 20113rd Congress
To Register | T +49 (0)30 20 91 33 30 | F +49 (0)30 20 91 33 12 | E [email protected] | www.ectd-kongress.de/MM
Obtaining drug marketing authorisation in the EU is a complex process, necessitating a broad range of knowledge in various areas of specialisation that requires Regulatory Affairs Managers to be a pharmacist, lawyer, quality manager and project manager in one. You can use various sources to draw up marketing authorisation applications, but if you are not sure what exactly you are looking for, it is easy to get lost in the sheer abundance of information and lose valuable time. In contrast, the Guide to Drug Regulatory Affairs eases you through the necessary procedures, comments on EU and EMEA documents and helps you draw up your application. ECV • Editio Cantor Verlag GmbH www.ecv.de
Medienpartner
Since 72 years, pharmind® has been the periodical to be read by decision-makers and multipliers of the pharma scene. Taking into consideration the national and international (in particular EU and FDA) regulatory environment, the entire range of issues involving the development, manufacture, and marketing/sales of pharmaceutical products is covered in depth. www.ecv.de
www.PharmCast.com is the world leading website designed specifically for pharmaceutical, clinical and biotechnology profes-sionals. www.PharmCast.com brings up-to-date information on pharmaceutical patents, FDA, news, jobs and Buyer's Guide to our visitors. It was created and is maintained by pharmaceutical and biotechnology professionals. Visit www.PharmCast.com and discover for yourself why it is so popular among professionals. www.pharmcast.com
wPharmaVOICE magazine addresses the challenges and trends impacting the life-sciences industry. PharmaVOICE's subscribers are also kept abreast of the latest trends through additional media resources, including WebSeminars, Podcasts, Videocasts, and White Papers. www.pharmavoice.com
Team DiscountsWe are offering attractive TeamDiscounts, please contact us!
09:30 Registration with coffee and tea
09:55 Chairman’s welcome & opening address
New EU Variations Regulation
10:00 Regulators view: Consequences of the New Variation Regulation for the eCTD • EU Module 1.4 specification • Switch from 1.3 to 1.4 during life-cycle • Worksharing and grouping, annual reporting Dr. Klaus Menges, Division Strategy and Planning-Unit Scientific Quality Assurance and Process Organisation, Federal Institut for Drugs and Medical Devices, BfArM
10:45 Industry View: 1 year New Variations Regulation • Experiences from MRP and DCP • Q&A Document for eCTD Variations - open questions • Impact of "Grouping" and "Annual reporting" on internal business processes" Dr. Hannes Perschinka, Regulatory Support, Gebro Pharma GmbH
11:30 Refreshment break & networking
eCTD in a special environment
12:00 Case Study: Managing MAH and Manufacturer Name Change Submissions in the case of a Company Take-Over • Name Change Project Introduction • Tools used for Submission Planning and Tracking • From high level planning to approval offirst submissions • Reporting tools • Logistic of Submissions in Europe • Submission Formats used • Impact of New Variations Guideline Elke Schydlo, Technical Services, Global Regulatory Affairs Manager, Submission Services Hannover, Abbott Products GmbH
12:45 Challenges faced by small and medium-sized companies • Does it make sense to implement eCTD in my company? • How do I get started? • Two case studies • Dos and Don'ts Oliver Denk, PhD, Director, Regulatory Affairs Pharma, PARI Pharma GmbH13:30 Networking Luncheon
PIM & eCTD/ digital signatures
15:00 The PIM Project - Exchange of well structured product information • Why Product Information Management (PIM)? • Structure and elements of the PIM-Project • Impact on the procedures of regulators and industry • Status Update and next steps Dr. Andreas Franken, Abteilungsleiter Klinische Forschung/ elektronische Datenübermittlung, BAH
15:45 PIM Submissions • Exchanging data in PIM • The PIM process / communication within PIM • The lifecycle of PIM / DES • PIM implemetation in eCTD Markus Pfahlert, Global Regulatory Operations, Merck Serono
16:30 Refreshment break & networking
17:00 Digital signatures in eSubmissions in Europe • Why digital signatures? The use of electronic submission gateways • The SAFE standard • The use of ‘flattened’ digital signatures • Pilot of digital signatures • Acceptance of digital signatures in the EU Hans van Leeuwen, Program Manager, Schering Plough Netherlands B.V.
17:45 Closing remarks of the chairman and end of day one
Get free white papers, articles and much more! www.ectd-kongress.de/MM
What’s in your download center?
The purpose of the download center is to provide you with relevant content to enhance your knowledge of current trends and industry news. All content is 100% complimentary, easy to download, and current.
Featuring live podcast interviews, available to stream on your computer or portable device, up-to-date news from local andinternational sources, industry whitepapers, and other relevant content – the download centre is your online portal for expanding your knowl-edge and adding value to your business.
We encourage your feedback and participation. For all comments or enquiries please contact Mark Reichmann or Hannah Schädler on+49 (0)30 20 91 32 74 or [email protected].
Efficient eCTD Submissions 20113rd Congress
CONGRESS DAy ONE | Monday, 31st January 2011
To Register | T +49 (0)30 20 91 33 30 | F +49 (0)30 20 91 33 12 | E [email protected] | www.ectd-kongress.de/MM
The Meliá Berlin invites you to an evening
reception. This is an excellent opportunity
for you to meet the other attendees and
make new business contacts.
For further Informationplease visit our website www.ectd-kongress.de/MM or contact Hannah Schädler or Mark Reichmann on +49 (0)30 2091 32 74 or email [email protected].
Regulator
Regulator
Regulator
Regulator
Regulator
08:30 Registration with coffee and tea
08:55 Chairman’s welcome & opening address Dr. Adam Aparicio, Head of Global Regulatory Operations, Merck Serono, Germany
Implementation and requirements of eCTD by EU Regulators
09:00 Electronic Marketing Authorisation Applications in Europe Today • e-Readiness : Regulators and Industry • EU Harmonisation: Guidance and Validation of submissions • The French experience Miguel Bley, Head of European Affairs, Agence Française de Sécurité Sanitaire des Produits de Santé (Afssaps)
09:40 e-submissions at the MEB and the EU portal • Current status of e-submissions at the MEB • Validation: Improving quality of your submission • CESP: The EU portal dream or reality Rob De Haan, Deputy Director MEB, College ter Beoordeling van Geneesmiddelen, Netherlands
10:20 Refreshment break & networking
10:50 Experiences with e-only eSubmissions in Germany • Conditions to move to e-only • Technical validation: improvement or burden • Quality of the dossiers • Recommendations for the future Dr. Klaus Menges, Division Strategy and Planning-Unit Scientific Quality Assurance and Process Organisation, Federal Institut for Drugs and Medical Devices, BfArM
11:30 Experience with e-only submissions in Denmark • Requirements for applicants • Experience from validation of e-submissions • Quality of dossiers received • Working in the Danish Agency’s fully digitalised environment Per Helboe, Senior Director of Division, Danish Medicines Agency
12:10 Networking Luncheon
13:20 Practical experience in handling eCTD submissions in Spanish Medicine Agency • eCTD and NeeS submission: Pros and Cons • Impact of the eCTD on regulatory processes • Common problems handling eCTDs in Spanish Medicine Agency José Manuel Simarro, División Tecnologías Información, Agencia Española de Medicamentos y Productos Sanitarios, AEMPS
Lifecycle Management – document strategies
14:00 One year of eCTDs in Switzerland - a project review • How to build Swiss Module 1 in eCTD • Ensuring successful validation of your submission • Article 13 in eCTD - referring to existing approvals abroad • Dos and don'ts for Swiss eCTDs Jörg Schnitzler, Associate Director Regulatory Operations, Regulatory Affairs Europe, Astellas Pharma Europe R&D
14:45 Refreshment break & networking
15:15 eCTD Lifecyle management: Milestones and Hurdles in a DCP • Initial Submission and Approval • Lifecycle of the application (Variations, PSURs, FUMs, etc) • eCTD and Worksharing • Feedback from Authorities Dr. Christian Dinter, Global Submission Manager, Bayer Schering Pharma AG, Germany
16:00 Strategies for documents and lifecycle management • Document preparation • Granularity options - high vs. low • Hyperlinking strategy options • Publishing and dossier lifecycle / re-usage Dr. Adam Aparicio, Head of Global Regulatory Operations, Merck Serono, Germany
16:45 Closing remarks of the chairman and end of congress day two
Efficient eCTD Submissions 20113rd Congress
Efficient eCTD Submissions 2011CONGRESS DAy TWO | Tuesday, 1st February 2011
To Register | T +49 (0)30 20 91 33 30 | F +49 (0)30 20 91 33 12 | E [email protected] | www.ectd-kongress.de/MM
IQPC provides business executives around the world with tailored practical congresses, large scale events, topical
seminars and in-house training programs, keeping them up-to-date with industry trends, technological developments and
the regulatory landscape. IQPC’s large scale congresses are market leading “must attend” events for their respective
industries. IQPC produces more than 1,500 events annually around the world, and continues to grow. Founded in 1973,
IQPC now has offices in major cities across 5 continents including: Berlin, Dubai, London, New York, São Paulo, Singapore,
Stockholm, Sydney and Toronto. IQPC leverages a global research base of best practices to produce an unrivalled portfolio
of congresses.
www.iqpc.de
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www.ectd-kongress.de/MM.
Workshop A09:30 – 13:00
Implementation of eCTD in sme (small and medium-sized companies)
As eCTD submissions are becoming the norm rather than an exception small and medium-sized companies are now trying to match their capabilities to what are now industries requirements. The implementation of eCTD format will require a huge effort therefore it is important to identify priorities in this process.
The participants of the workshop will learn:• How to reach a decision whether to choose an in-house solution or an outsourcing solution.• What criteria need to be looked at when choosing the right software tool for eCTD publishing?• What is the best approach to implement eCTD in your company?• Which departments need to be involved in the process?The workshop will be held in a very interactive manner.
Oliver Denk, PhD, Director, Regulatory Affairs Pharma, PARI Pharma GmbH
Efficient eCTD Submissions 2011 Efficient eCTD Submissions 20113rd Congress
INTERACTIVE WORkSHOPDAy | Wednesday, 2nd February 2011
To Register | T +49 (0)30 20 91 33 30 | F +49 (0)30 20 91 33 12 | E [email protected] | www.ectd-kongress.de/MM
Workshop B09:30 – 13:00
eCTD Technical Validation Criteria - How to get eCTDs through technical validation at agencies
Workshop C14:00 – 17:30
Successfully managing eCTD lifecycles
Workshop D14:00 – 17:30
PIM & eCTD
The EU eCTD Validation Criteria (v2.1) were published in April 2009. Many European agencies have already started to perform technical validation of incoming eCTDs and to reject eCTDs not complying with the validation criteria. Different tools for checking the validation criteria are made available to the public by agencies and vendors (EURS Validator, eValidator, eCTD Checker). As the interpretation of validation criteria is different between the tools, one eCTD may lead to different validation results than another.
This workshop will cover• Introduction to publicly available validation tools (EURS Validator, eValidator, eCTD Checker)• Interpretation of validation results from different tools• How should an eCTD be structured to pass all (publicly available) validation tools?• Outlook on update of EU eCTD Validation Criteria: TIGes has announced that it will issue updated EU validation criteria by the end of 2010Dr. Hannes Perschinka, Regulatory Support, Gebro Pharma GmbH
To handle the eCTD lifecycle successfully means to be aware of some common pitfalls. Therefore this workshop will provide you with solutions to solving problems which arise during lifecycle management.
The following topics will be covered:• Defining level of granularity• Hypertext link/bookmarking• Changes during lifecycle• Grouping and worksharing• Switch from paper to eCTD during lifecycle
For further Information visit our website: www.ectd-kongress.de/MM
The content of product information texts for medicinal products is part of any marketing authorisation. SPC, package leaflets and labeling contain important information for both patients and for professionals such as doctors and pharmacists. The marketing authorisation holder is responsible for the creation as well as for the maintenance of these informative texts. While for a national approval only a few pages of text are necessary, the scope of work expands as soon as the product is marketed in multiple countries with different languages and in addition in different strengths and / or formulations. A structured electronic generation and submission of these texts, starting with the centralized procedure and maybe later also for other drug application procedures, is needed as even today the basic regulatory processes are increasinglyconverted to paperless communication. The workshop will vividly demonstrate the preparation and handling of product information in accordance with the requirements of the EMA for PIM. For this the structure of XML documents with the basic idea of multiple use of information and their advantages in the document maintenance are presented and explained. This includes an introduction to the free tool for this purpose, the EMA (Light Authoring Tool, LAT).
Dr. Andreas Franken, Clinical Research / eSubmission, German Medicines Manufacturers Association, BAH
If undeliverable, please return to: IQPC GmbH | Friedrichstraße 94 | D-10117 Berlin, Germany
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Congress Packages
A: Implementation of eCTD in sme (small and medium-sized companies)B: eCTD Technical Validation Criteria - How to get eCTDs through technical validation at agenciesC: Successfully managing eCTD lifecyclesD: PIM & eCTD
31st January – 2nd February 2011 | Meliá Hotel, Berlin
