POINTS PER WHERE REGULATORY MEETS E-REGULATORY: … · Bristol-Myers Squibb eSUBS: An update on...

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21 - 23 APRIL 2020Hotel Palace BerlinBerlin, Germany

WHERE REGULATORY MEETS E-REGULATORY: BRINGING ANSWERS TO THE PHARMACEUTICAL INDUSTRYTake your strategy to the next level with leading advice from Regulatory Authorities, key stakeholders and global perspectives

Regulatory Information

ManagementWorkshop:

Filing VariationsRegulatory Affairs in Global Markets

Global eSubmissions

Patrícia Kott Tomazett,

Health Regulation Specialist, General

Management of Drugs – GGMED,

Brazilian Health Surveillance Agency –

ANVISA

Dr. Jörg Stüben, Head of Regulatory

Information Management & Senior Expert,

Boehringer Ingelheim International GmbH

For more information visit informaconnect.com/global-pharmaceutical-regulatory-affairs/

Dr. Dai Wan, Regulatory Project

Manager Biopharma | Global Regulatory Affairs

& Quality Assurance, Merck

@PharmaRegsIC | #GLOBALRA

Vada A. Perkins, Head, Regulatory

Intelligence, Director, Regulatory Policy &

Intelligence, Bayer

UP TO 15 CPD POINTS PER

STREAM

3 STREAMS1 WORKSHOP1 LOCATION

DAY 1TUESDAY 21ST APRIL

DAY 2WEDNESDAY 22ND APRIL

DAY 3THURSDAY 23RD APRIL

Regulatory Affairs in Global Markets: Asia Pacific

(APAC)

Regulatory Affairs in Global Markets: Latin America

(LATAM)

Regulatory Affairs in Global Markets: Commonwealth of

Independent States (CIS)

Global eSubmissions Global eSubmissions

WORKSHOP: Filing VariationsRegulatory Information

ManagementRegulatory Information

Management

AGENDA AT A GLANCE

For more information visit informaconnect.com/global-pharmaceutical-regulatory-affairs/2

@PharmaRegsIC | #GLOBALRA

Build your pass:Choose your days and topics of interest, and make the most of the opportunity to move between all of the conference streams.

DAY ONE: TUESDAY 21 APRIL08.00 IDMP Breakfast Briefing

Sessions focusing on IDMP, including the new guideline documents that have been released in February 2020. This session will include input from IDMP/ SPOR Task Force Members. Full session details to be announced!

TRACK 1: Regulatory Affairs in Global Markets

TRACK 2: Regulatory Information Management

TRACK 3: Global eSubmissions

Regulatory Affairs in APAC RIM/IDMP Global eSubmissions

09.00 Opening remarks from the ChairpersonDr. Ching Li, Regulatory Affairs Manager, Corporate Regulatory Affairs, Biotest Pharma GmbH

Opening remarks from the ChairpersonMichiel Stam, Head of Data Management & Regulatory Information ScientistQDossier

Opening remarks from the Chairperson

09.10 Regulatory reform and the drug approval process in China: where are we now?• Understanding China’s move towards

ICH standards: what are the hurdles and what will it mean for approval time-lines?

• Assessing the time-lines for gaining product approval in China

• Understanding the extent to which regulatory approval in China has improved

Dr. Ching Li, Regulatory Affairs Manager, Corporate Regulatory Affairs, Biotest Pharma GmbH

The value of RIM and upcoming challenges and opportunitiesRemco Munnik, Regulatory Information Director, Iperion

HEALTH AUTHORITY AND INDUSTRY PANEL DISCUSSION: Global eSubmissions regulatory landscape: Preparing for the future• Assessing the strategic road maps for

electronic submissions • Assessing opportunities for alignment

and harmonisation amongst Health Authorities to improve submissions globally

• Examining common pitfalls during eSubmissions processes and how they can be avoided

• Advice for industry when planning a global eSubmissions strategy

Panelists: Alastair Nixon, Director, Publishing, GlaxoSmithKlineMassimiliano Sarra, AIFA (subject to final confirmation)Tim Powell, Associate Director, Submission Sciences, Biogen

09.45 Industry case study: Gaining product approval in China and examining the new clinical trial regulation • The new clinical trial regulations:

definition and scope• Examining common challenges when

conducting clinical trial in China o Bridging from one region of clinical

data to another – how is this being addressed? Where is the data gap?

o Hospital clinical trials: How can industry ensure data quality?

• Sharing experiences of China’s silent approval process for clinical trials: what is the process and what impact does this have on approval times?

• Local clinical trials in China versus acceptance of global clinical data

• Targeting the unmet medical need: how are new therapies being registered in China?

• Practical advice for building a regulatory strategy in China

SPOR: An update on theimplementation guides: Scope,requirements and advice for industry• Walking through the implementation

guides step by step• Assessing how the implementation

guides are being interpreted• Industry feedback on the draft

implementation guides• An update from the task force on

expected time-lines• Lack of available guidance for iteration onePatrick Middag, Lead IT Business, Partner for Regulatory EU and Data Capabilities, Bristol-Myers Squibb

3For more information visit informaconnect.com/global-pharmaceutical-regulatory-affairs/3

10.20 INDUSTRY CASE STUDY: GMP inspections on foreign manufacturing sites by NMPA ChinaRegistration of imported pharmaceutical products in China• Understanding on what conditions an

oversea inspection would take place• Feedback from a recent NMPA GMP

inspection in Europe

Jianhui Sun, APAC Regulatory Affairs Manager, SEPTODONT

Enhancing the overall efficiency of global Regulatory Information ManagementMarty Boom, Global Head of Regulatory & Safety / Managing Director Europe, Navitas

SPOTLIGHT PRESENTATION

10.55 - Morning Coffee & Networking Break

11.20 Trace and traceability in China – the past, the present and the future • Chinese requirement on serialization

and aggregation• Traceability systems (government,

manufacturer, distributors and consumers)

• Difference between EU requirement and Chinese requirement

• Impact on the industry

Dr. Ching Li, Regulatory Affairs Manager, Corporate Regulatory Affairs, Biotest Pharma GmbH

Defining robust data flows forRegulatory and IDMP to become adata driven organization• Making use of data that is residing in

various sources• Bringing data it into the right context

and ensuring data quality• Defining one global language for data,

based on ISO IDMP but flexible to evolve rapidly as per business needs and/or health authority requirements

Dominik Gigli, Senior Manager Regulatory Compliance & Regulatory Information Management, Merck

EFPIA recommendations for eCTD• Overview of eCTD implementation

progress globally • Recommended time-lines & approach

for new countries considering adopting eCTD

• How industry can engage and influence locally, and support the approach taken by health agencies

• Highlight the benefits that eCTD brings and share examples from existing regions

Tim Powell, Associate Director, Submission Sciences, Biogen

11:55 INDUSTRY ROUNDTABLE: Sharing experiences of product approval in China• Assessing the best regulatory pathway

for product approval in China• Discussing common challenges faced

by industry during the registration process

• Sharing best practice for maintenance

Dr. Michael Gebauer, Senior EP Expert, Bayer

PANEL DISCUSSION:Target Operating Model (TOM):Assessing the benefits of the TOMfor the industry• Understanding the extent to which TOM

will enable higher quality data with a higher level of consistency

• Understanding how the data is going to be submitted and when it is going to be assessed

• Feedback from the stakeholder implementation group

Panelists:Patrick Middag, BMS, Belgium Laurent Lefebvre, Regulatory CMC and RIM System Delivery Lead, Novartis Pharma AG

Simplifying Regulatory Processes for Post-approval Changes with Unified RIMManaging post-marketing variations is complicated and time-consuming. It requires coordination across multiple internal stakeholders and communication with various external health authorities to stay in compliance. With a unified RIM platform, Veeva simplifies the post-approval variation process by consolidating fragmented information and automating manual tasks. In this session, we’ll explain how companies can speed variation management by running impact assessments, auto-generating submission plans, using structured data to author documents, and auto-publishing as documents are written. By doing so, companies will improve visibility into which documents need updating, are missing, or have already been submitted and enhance collaboration between headquarters and affiliates. Attendees will also learn why it’s critical to leverage a unified RIM suite, rather than one that simply integrates applications, to handle the complexity and duration of the variation management process.  Katrin Spaepen, Director Strategy, Vault RIM, Veeva Systems

12:30 - Networking Lunch

Comprising eRegulatory Summit and Global Markets

DAY ONE CONTINUES: TUESDAY 21ST, APRIL

4For more information visit informaconnect.com/global-pharmaceutical-regulatory-affairs/4

5

14:00 Assessing regulatory harmonisation in the ASEAN region• Examining the variation regulation

in the ASEAN region: Understanding different countries interpretations of the guideline

• Upcoming changes in the region

• Advice for industry

Anna Hanzlikova, Head of Global Regulatory Affairs, Promedcs

Regulatory Automation and how toeffectively leverage AIJim Nichols, COO, Cunesoft

eCTD v4.0: Time-lines, scope and industry feedback• Assessing the status of eCTD v4.0 • Examining the time-lines for

implementation • Assessing feedback from ICH and

industry

Bernd Misselwitz, Director, Regulatory Submission Management BLN / WUP, Bayer

14.35 Assessing regulatory requirements and expectations in Japan • Key Regulatory Aspects for New

Vaccines Development in Japan • Understanding the best way to interact

with PMDA • Approval time-lines in Japan –

standard and accelerated review systems

Arturo Gonzalez-Martinez, PhD, Regional Regulatory Affairs Latin America & Japan, GSK

Using AI in the regulatory space• Wishful thinking and reality• Validation aspects• Future trendsDr. Jörg Stüben, Head of RegulatoryInformation Management & Senior Expert, Boehringer Ingelheim International GmbH

DEBATE: eCTD v4.0 – the future vision? Putting forward the argument for and against • Assessing the benefits of eCTD v4.0

for Industry and patients • Examining the risks associated with

moving towards eCTD v4.0: Will it hinder global rollout of new products? Will the software be good enough to convert between them? Are the publishing tools robust and reliable enough?

• Assessing the argument for continuing with v3.2

• Understanding the extent to which a move towards ectd v4.0 may impact international harmonisation

Alastair Nixon, Director, Publishing, GlaxoSmithKlineRodrigo Palacios, PTR Global Head for Business Systems, Regulatory Technology Policy Lead, Roche

15.10 Examining the regulatory landscape in India • Assessing clinical trial requirements

in India• Planning a regulatory strategy for

product registration in India• Product approval requirements• Case examples of successful product

registrations in India

Malika Alamansouri, Emerging Markets Expert, Global Regulatory Affairs Vaccines, GSK

Finding YOUR Future-Proof E2E RIM Solution - Considerations for Search and Selection”Speaker: Fabian Witzel, Corporate Development Manager, LORENZ Life Sciences Group

eCTD preparedness in Brazil: Where are we now?• Understanding where ANVISA is in

their journey towards being eCTD-ready   • Assessing what direction ANVISA is

taking • Gaining insight into the wider

discussion happening in LATAM

Patrícia Kott Tomazett, Health Regulation Specialist, General Management of Drugs – GGMED, Brazilian Health Surveillance Agency – ANVISA

15.45 - Afternoon Coffee and Networking Break




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16.15 Understanding the latest regulatory requirements in South Korea • Examining clinical data requirements

for market entry in South Korea• Assessing post-approval requirements

Alan Chalmers, Owner, Pharma International

INDUSTRY CASE STUDY: Using IDMP to leverage available data connections for business benefit• Gaining senior management buy-in

to make budget available for IDMP investment

• Case examples• Lessons for Industry

Jen Klesh, Associate Director, Medicinal Product Data Management, Bristol-Myers Squibb

eSUBS: An update on CESSP• Assessing progress on the internal

testing of the solution• Examining the information available on

the portal• How close are we to phase 1 of the

CESSP?• Migrating the Electronic Application

form into the CESSP• How will IDMP be linked to the CESSP?

Alastair Nixon, Director, Submission Standards, Global Regulatory Platform and Delivery, GlaxoSmithKline Research & Development Limited, UK

16.50 Improving regulatory harmonisation for generics: ACSS – GMWST-A DCP Pathway outside of EU• An introduction to the pilot• Assessing regulatory feedback so far• Future plans

Fail Fast - Learn to navigate and deliver valuable success to the regulatory network

Anjana Pindoria, Director Product Strategy, EXTEDO

17.25 HL7 FHIR standard: Where are we now?• Clarifying the definition and scope of FHIR • Assessing the benefits of the FHIR standard:

how will it improve ways of working? • Understanding where the standard is being utilised and understanding what tools are available to utilise it • How might industry and regulatory domain use FHIR?

Vada A. Perkins, Head, Regulatory Intelligence, Director, Regulatory Policy & Intelligence, Bayer

18:00 Chairman’s Closing – End of Day 1 and Networking Drinks




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DAY TWO: TUESDAY 22ND APRIL08.00 Registration

TRACK 1: Regulatory Affairs in Global Markets

TRACK 2: Regulatory Information Management Track 3: Global eSubmissions

Regulatory Affairs in LATAM RIM/IDMP Global eSubmissions

09.00 Opening remarks from the Chairperson Opening remarks from the Chairperson Opening remarks from the Chairperson

09.10 Regulatory requirements for registrations: evaluation of efficacy, safety and quality • Understanding Anvisa pathways for

product registration

Patrícia Kott Tomazett, Health Regulation Specialist, General Management of Drugs – GGMED, Brazilian Health Surveillance Agency – ANVISA

ISO IDMP related implementation at and by the regulator - MEB experience and views on substance management• Progress on the implementation of IDMP substance management through

EU-SRS • Views of a National Competent Authority on the role of data in regulatory

exchange • Relation of standards to the telematics plan of the MEB • Discussing the status of SMS implementation in the EU

Joris Kampmeijer, CIO, Medicines Evaluation Board and Frits Stulp, EU-SRS Project Manager

09.45 Managing the authorities increasing regulatory expectations in Latin America• Factors influencing regulatory

development in the region • Making sense of a diverse regulatory

landscape - Regulatory trends• Key considerations for regulatory

strategies – reliance, convergence and harmonization

• The challenge of ensuring compliance while securing seamless supply

Arturo Gonzalez-Martinez, PhD, Regional Regulatory Affairs Latin America & Japan, GSK

The Clinical Trial Portal: Assessing the status• When does it go live?  • Understanding the potential links to the medical device industry – how might

the portal be linked to implementation of the UDI and EUDAMED? • How will it link to serialisation activities and RIM?

Sol Yates, Associate Director, Global Regulatory Affairs, Grünenthal GmbH

10.20 Clarifying GMP inspection expectations in Brazil: what is ANVISA looking for?• Understanding the requirements for

GMP inspections in Brazil • Assessing expectations from

ANVISA and examining the current rate of rejection

• Examining the time-lines for GMP inspections

• Advice for industry

INDUSTRY CASE STUDY: Transforming from a document-driven to the regulatory organisation into a data driven organisation• Highlighting practical examples and strategic insights into how businesses

can achieve this shift • Assessing how the move is being tackled from a technology perspective • Understanding how to become more flexible to regulate data beyond

regulatory affairs • Understanding the authoritative source of your data and getting the most

value out of it

Marcos Fernandez, Regulatory Affairs Associate Director, Asphalion

10.55 - Morning Coffee and Networking Break


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11.25 Biosimilars guidelines in Brazil: Examining strategies to ensure registration • Comparing Brazilian requirements to

US and EU• Understanding the common pitfalls

when trying to register biosimilars• The biosimilar marketplace in Brazil:

a snapshot

Thomas Kirchlechner, Director Regulatory Policy & Intelligence, Sandoz Biopharmaceuticals

PANEL DISCUSSION: Redesigning the regulatory landscape: Assessing the paradigm shift from today´s standard way of working towards a data-driven future• Examining the move in industry from a document to data driven approach • Assessing the best approach for structured content authoring from a

business point of view • Understanding how to get insight out of your data towards a more flexible

data model • How can industry shift from a siloed to an integrated way of thinking and

working?

Vada A. Perkins, Head, Regulatory Intelligence, Director, Regulatory Policy & Intelligence, BayerRodrigo Palacios, PTR Global Head for Business Systems, Regulatory Technology Policy Lead, Roche

12.00 SPOTLIGHT SESSION

12:35 - Networking Lunch

14:05 Serialisation in Latin America: Where are we now?• Serialisation: what & why?• Experience on implementation in

Argentina• What is coming for LATAM?

Maria Alejandra Blanc, Director - Regulatory Affairs – Region South, Technical Director – Argentina, AbbVie

Presentation to be delivered by Amplexor

How electronic are Electronic Submissions?Marie Ward, Regulatory Services Lead, Accenture

14.40 COFEPRIS transformation: Assessing the requirements for product registration and post-approval changes in Mexico• Understanding what the Mexican HA

requires from industry• Understanding the reasons behind

the significant data request from the authority and understanding what is required to ensure compliance

• Success strategies of reducing the burden when applying to Mexico

Luis Alberto Cervantes Muciño, Regulatory Affairs Manager, AbbVie Farmacéuticos

Best practice for implementation of OMS and understanding the links to other regulatory processes• Understanding the OMS & RMS

implementation processes • Clarifying how OMS will link to

the clinical trial portal using SPOR service

Jean-Michel Cahen, IDMP Project Lead – Associate Director, Regulatory Submission Stds and Strategy, GDD RA Operations, Novartis Pharma AG

eSubmissions in GCC: Examining the latest updates in the region and assessing opportunities for harmonisation• Feedback from an EFPIA company:

How can industry influence GCC countries improve alignment with other regions, and standardisation within the GCC region

• Successes and challenges of working in the region

Anna Sokołowicz, Acting Senior Manager, Submission Production GlaxoSmithKline

15.15 New Regulatory Framework for API in Brazil. Point of view of EU Industry• Presentation of Leem and Brazil

Working Group• Presentation of slides about content

of new Brazil API legislation and position of EU Industry

• Section for questions and comments from Participants

Julie Assedo, Director of International Affairs, LeemAna Luisa Fritschy, Manager Regulatory Affairs, Leem

Structured Authoring• Examining the key concepts

of structured authoring and understanding how it works

• What are the challenges associated with structured authoring?

• Case examples of the benefits such capabilities can bring to a regulatory organization

• Taking a phased approach to the introduction of structured authoring in your organization

Wim Cypers, Aris Global

Manage the Complete Regulatory Lifecycle with an End-to-End RIM System

Explore the benefits of integrating a comprehensive RIM solution (including eSubmissions) with global, country-level regulatory intelligenceDiscuss strategies for faster filing and improved cycle timesExamine how predictive analytics (proprietary AI and ML) drive fast, accurate and proactive response Discover how leading technologies and unparalleled domain expertise are transforming regulatory operations

Cecile Riboud, Senior Director EuropeIntegrated Global Compliance , IQVIA

15.50 - Afternoon Coffee and Networking Break


DAY TWO CONTINUES: WEDNESDAY 22ND, APRIL


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16.20 INTERACTIVE DISCUSSION: Sharing experiences of product registration and post-approval changes in a global market• Preparing dossiers for several

countries and bringing synergies to the preparation of submissions to variations

• Strategies for taking a global approach instead of regional  

Anna Hanzlikova, Head of Global Regulatory Affairs, Promedcs

INDUSTRY CASE STUDY: Delivering on a new RIM platform - From Vendor Exploration to Initiating ImplementationDavid Cook, Business Systems Lead (Pharma Technical Regulatory), F. Hoffmann-La Roche Ltd

eSubmissions in Turkey• Understanding the current system

for online submissions to Turkey • Assessing Turkey’s plans for moving

towards the eCTD • Advice for industry

Figen Kabadas, Head of Regulatory Affairs, Delpharm

16.55 Locally applied, locally acting products – Current evolution of regulatory requirements• Update of the EMA Guidance and its

impact on applicants’ strategies • Contrasting the EMA Guidance with

US FDA Product-Specific Guidances• How about RoW and requirements

for topical products?

Darius Namdjou, Global Regulatory Strategist, Grünenthal GmbH

Small Scale Automation And Why Everyone Is Missing Out• What does Automation really mean• Missed opportunities on smaller

scales• Leveraging untapped potential of

internal technical skillsets• How to make a real difference and

measure it• Further examples of small scale

AutomationHenry Quinn, Senior Regulatory Operations Associate, Gilead Sciences Ltd

An update on eSubmissions in China• Providing clarification on the move

to the eCTD• Assessing available guidance for

eSubmissions in China• Practical advice for submitting to

China• Examining the common pitfalls and

understanding how to overcome them

Dr. Dai Wan, Regulatory Project Manager Biopharma | Global Regulatory Affairs & Quality Assurance, Merck

17.20 Developing a global regulatory strategy in times of regulatory uncertainty and change• Assessing commonalities and

differences between specific local requirements across regions

• Outlining the challenges facing regulatory professionals in post approval world an ensuring supply continuity

• Overcoming the challenges of variety and variability of regulations and time-lines across the globe

Alessandra Leone, PTx Global CMC Senior Manager, Pfizer

Understanding the changing environment in Russia and assessing the impact on eSubmissionsKonstantin Koshechkin, Head of Informatization Department, The Federal State Budgetary Institution “Scientific Centre for Expert Evaluation of Medicinal Products

18.00 End of Conference Day 2


DAY TWO CONTINUES: WEDNESDAY 22ND, APRIL


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DAY THREE: TUESDAY 23RD APRIL08.00 Registration

TRACK 1: REGULATORY AFFAIRS IN GLOBAL MARKETS

TRACK 2: REGULATORY INFORMATION MANAGEMENT

Regulatory Affairs in Russia, CIS and EAEU, Turkey and MENA Filing Variations Focus Day

09.00 Opening remarks from the ChairpersonAlex Dranov, Senior Regulatory & Scientific AffairsManager, Dr Willmar Schwabe

This workshop will be run by PTI trainer: Sumaiya PatelSumaiya Patel is a director of a regulatory consultancy with over 11 years’ experience in both pre and post-approvals for generic, CRO and big pharma organisations. Sumaiya has experience in regulatory implementation and training, focusing on CMC, clinical development, strategy and manufacturing. She has extensive experience in writing Module 3 of CTD, Module 2 of the CTD and also Quality Expert statements to support dossiers and Type II Quality variations. She has a track record of providing regulatory inputs related to CMC aspects during the development product lifecycle.

09.10 Registration of known APIs - practical experiences in RF and EAEU• Exploring the latest regulatory requirements from Russia• Guidance on the necessary preparation for clinical trials• Advice for successfully registering pharmaceuticals in

Russia• Localization of manufacturing

Edelgard Rehak, Edelgard Rehak Consulting

Basis of Regulations 1234/2008 and 712/2012 in Europe• Classification in accordance with the legislation• Understand the differences between Type lA, Type IB and

Type ll variations• Clarify foreseen and unforeseen Variations• Sharing practical experience with European and national

procedures• Assessing how pharmaceutical companies are operating

in this evolving regulatory environment• Working with Regulators: Lessons learned

09.45 Assessing regulatory strategies for successful registration in CIS region• Overview of regulatory requirements across the region

(Ukraine, Moldova, Uzbekistan, Georgia, Azerbaijan, Tajikistan, EAEU countries)

• Defining similarities and differences between countries• Assessing potential challenges during registration in CIS

Anastasiia Havrylianchyk, Senior Regulatory Affairs Specialist, Marketing Authorization Department Growth Direction Pharmaceutical Corporation YURiA-PHARM

Practical exercise: Analysing and classifying the different changes• Analysing and classifying the different changes• Analyse different changes• Consider the conditions and documentation

requirements• Practice classifying the changes

10.20 Registering new therapies for orphan diseases in Russia and CIS• Gaining local market knowledge to help prepare your

submission• Understanding what health authority requirements are• Assessing the correct format for dossier preparation and

submission in Russia• Sharing experiences of successful submissions• Lessons for industry

Galina Senchukova, Head of Product Market Authorization and Quality Assurance Russia & CIS Branch of CSL Behring Biotherapies GmbH in Russia, CSL Behring, RF

Grouping and worksharing• Understanding when grouping is appropriate• Clarifying what types of Variations may be grouped• Guidance on assembling a grouped submission• Understanding when worksharing is appropriate• Discussion of example cases


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10.55 - Morning Coffee & Networking

11.25 Examining and providing clarification on the EAEU legislation development • Examining the implementation status – which countries

have already implemented the legislation?• What are EAEU legislation requirements for GMP

inspections?• How does EAEU legislation differ from Russian

legislation?• Understanding how the EAEU compares to the

centralized procedure in Europe• Assessing different countries’ interpretations of the

EAEU legislation

Pelin Boran, Founder, Pelin Boran Regulatory Affairs Solutions & Consultancy

Filing Tips• Submitting Type IA, IB and Type II applications• Understand how to ensure that your dossier is complete• Learn how to get it right first time• Find out what to do when your application is rejected

12.00 Preparing for Russian GMP inspections• Requirements for documentation complete and

sequence of actions of applicants for organization and supporting of Russian GMP Inspections

• Data analysis based on the results of Russian GMP inspections. Exchange of experience: frequently encountered deviations, questions and possible solutions

• How do Russian GMP inspections compare to EMA inspections? Harmonization of Russian regulatory system with international requirements

Ivan Guliaev, Head of the Training and Development Department, Inspectorate of FSI «SID&GP»

Discussion - Troubleshooting your Filing Variation plan• Group discussion Share experiences

12.35 CIS region regulatory environment overview. Reality & Estimation.Anna Pogodaeva, Executive Director at Pharmagate Ltd., Ukraine

Global variations Examine the filing variation requirements in key regions and countries comparing them with the EU:US / APAC (ASEAN variation regulation / China) / Russia & CIS / LATAM (Brazil/ Mexico)

13.10 - Networking Lunch

14.30 Serialisation and labelling in Russia: What you need to know now to ensure complianceExamining Russia’s serialisation legislation: what’s new?• How do Russia’s serialisation requirements compare to

Europe’s?• Understanding what steps industry need to take to

ensure products are serialised • Assessing how implementation has gone so far and

understanding the challenges and opportunities

Alex Dranov, Senior Regulatory & Scientific Affairs Manager, Dr Willmar Schwabe

Global regulatory strategy for Filing Variations • Practical guidance to formulating a global regulatory

strategy • Aligning different documentation requirements • Implementing variations with different approval timelines


DAY THREE CONTINUES: THURSDAY 23RD, APRIL


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15:05 INDUSTRY CASE STUDY: Practically implementing Russia’s new serialisation requirements• Understanding the impact serialisation has on the

regulatory process –what changes had to be made to the regulatory process?

• Understanding the requirements for mock up approval – who needs to be involved?

• Strategies for providing product specific and MAA specific information to enable serialisation

• Lessons for industry

Alexander Borisov, Regional Regulatory Affairs Manager Centrient Pharmaceuticals, RF

Discussion – Troubleshooting your global variation strategy• Group discussion • Share experiences

15.30 - Afternoon Coffee & Networking

16.00 Success strategies for registrations in the MENA region• Reviewing the current regulatory environment in the

MENA region• Practical advice when registering in the MENA region,

including an overview of registration requirements and time-lines

• Overcoming key challenges experienced with drug registrations in the MENA

Tine Vermeulen, Owner, Planpharma

Practical exercise • Data requirements for more complex changes• Assess the data requirements for Type II Variations• Consider extending use into a new patient populationIntegrating new safety information

16.30 Turkey’s regulatory landscape: what’s new?• Examining Turkey’s Health Transformation programme

and understanding its impact on access to medicines• Latest regulation on the registration of medicinal product

(MA submission prioritisation, upcoming guidelines etc.)• Assessing localisation and overcoming the challenge of

GMP inspections for import drug products

Figen Kabadas, Head of Regulatory Affairs, Delpharm

Case study exercise • Work through an example potential change in an MRP

authorised product• Plan the time-lines for and project management of a

Variation submission

17:00 End of Day 3 and Close of Conference



DAY THREE CONTINUES: THURSDAY 23RD, APRIL

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CONNECT WITH KEY BUYERS AT THE GLOBAL PHARMACEUTICAL REGULATORY AFFAIRS SUMMIT 2020 IN BERLINWhether you’re increasing your company profile, launching a new product or focusing on new business development opportunities, collaborate with us to identify custom solutions to help you reach your goals. Contact Dylan Smith: [email protected] | +44 (0)20 3377 3237

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