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Showing of Streams
10:55 - 11:25

Networking Break and Morning Coffee

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Showing of Streams
13:10 - 14:40

Networking Lunch

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Showing of Streams
15:50 - 16:20

Networking and Afternoon Tea

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Showing of Streams
09:00 - 09:10 10 mins
Filing Variations
Chairperson's Remarks
09:00 - 09:10 10 mins
RIM & IDMP Compliance
Chairperson's Remarks
09:10 - 09:45 35 mins
Info
Filing Variations
Comparing filing variation requirements in Brazil and EU
  • Darius-Jean Namdjou - International Regulatory Project Lead, Grünenthal GmbH, Germany

Speakers are asked to select a region from above to discuss some of the following points:

  • Outlining country-specific variation and renewal requirements
  • How do variation requirements compare to the EU?
  • Sharing practical experiences, hints and tips for successful variations in the region
  •  Overcoming key pitfalls experienced with variation
09:10 - 09:45 35 mins
Info
RIM & IDMP Compliance
Practical feedback on integrating manufacturing and marketing systems for effective RIM
  • Tim Powell - Associate Director, Global Regulatory Operations, Biogen
  • Understanding how manufacturing and marketing systems should be integrated into RIM systems
  • Common hurdles with integrating manufacturing and marketing systems
  • Avoiding common pitfalls
09:45 - 10:20 35 mins
Info
Filing Variations
Comparing filing variation requirements in the EU to the US
  • Baerbel Grossman
  • Highlighting key comparisons for filing variations in the EU and US
  • Exploring differences in specific requirements, notifications and timelines
  • Differences in annual reporting and how these should be submitted in the EU and US
  • Examining examples of supporting data used for CMC-related variations in the US and what should be prepared


09:45 - 10:20 35 mins
Info
RIM & IDMP Compliance
Exploring how RIM and IDMP can be used to successfully store artwork
  • Moncef Kafi - Head of Regulatory Compliance, GUERBET, France
  • Assessing how important up to date artwork is
  • How to successful transfer Artwork across databases
  • Ensuring artwork is up to date
10:20 - 10:55 35 mins
Info
Filing Variations
PANEL DISCUSSION: Sharing experiences with global variation strategies
  • Aurélie Mieze-Richard - Head of CMC-RA - Regulatory Affairs Pharmacist, Guerbet
  • Darius-Jean Namdjou - International Regulatory Project Lead, Grünenthal GmbH, Germany

A chance for delegates to answer further questions from the global session.

10:20 - 10:55 35 mins
Info
RIM & IDMP Compliance
Insights in how to structure a client – vendor partnership
  • Segren Bernard - Associate Director, Regulatory Information Management, Norgine
  • Katrin Spaepen - Director Strategy, Vault RIM,, Veeva Systems

 This presentation is a case study of how Veeva and Norgine collaborated successfully together to transform Norgine’s regulatory environment through the implementation of Veeva’s Vault RIM suite. It will provide insights in the do’s and don’ts both from the clients’ perspective and from the vendor’s perspective.


10:55 - 11:25 30 mins
Networking Break and Morning Coffee
11:25 - 12:00 35 mins
Info
Filing Variations
Case study: Practically implementing successful global variation strategies
  • Aurélie Mieze-Richard - Head of CMC-RA - Regulatory Affairs Pharmacist, Guerbet
  • Aligning different country documentation requirements and expectations
  • Filing variations across global markets with different approval timelines
  • Understanding whether to implement a change in Europe first then globally, or simultaneously
  • How does a global strategy differ from a European strategy?
11:25 - 12:00 35 mins
Info
RIM & IDMP Compliance
Understanding the FDA CMC submission standard
  • Costas Mistrellides - IDMP Regulatory Affairs Coordinator, Johnson & Johnson Consumer, UK
  • Updates from the FDA explaining the CMC submission standard
  • Outlining how CMC should be integrated into RIM systems
  • FDA expectations
12:00 - 12:35 35 mins
Info
Filing Variations
Practically implementing an effective grouping strategy for filing variations
  • Gry Agapitos - Senior Regulatory Affairs Professional, ALK Abelló, Denmark
  • Determining how a grouping strategy is planned, communicated and implemented
  • Outlining the key pros and cons of grouping variations
12:00 - 12:35 35 mins
Info
RIM & IDMP Compliance
Case study: Complying with FDA CMC Submission standard and incorporating this into a RIM system
  • Rodrigo Palacios - PTR Global Head for Business Systems, Roche
  • The challenges with CMC integration
  • Overcoming key challenges integrating CMC changes into a RIM system
  • Ensuring compliance
12:35 - 13:05 30 mins
Filing Variations
Share experiences with grouping variation strategies: pros and cons in form of interactive discussion
  • Michel Mikhail, Expert in International Regulatory Affairs and Biosimilars, Germany
12:35 - 13:10 35 mins
Info
RIM & IDMP Compliance
Data Governance – They key to high-quality data and success for RIM implementations
  • Jens-Oalf Vanggard - Director, Research and development, Highpoint Solutions
  • What is data governance and what does it mean in practice?
  • Why is data governance essential to the success for RIM implementations and what are the benefits?
  • Case Study: Defining a common product data governance model across Regulatory and Pharmacovigilance
13:10 - 14:40 90 mins
Networking Lunch
14:40 - 15:15 35 mins
Filing Variations
Setting up an overall project organization for serialization & T&T implementation projects: Means and methods for actively undertaking anti-counterfeiting measures
  • Darius-Jean Namdjou - International Regulatory Project Lead, Grünenthal GmbH, Germany
14:40 - 15:15 35 mins
Info
RIM & IDMP Compliance
RIM Technology: Understanding Process Development
  • Kim Brownrigg - Associate Director, Global Regulatory Affairs, Accenture
  • Why the Regulatory industry is primed and ready for automation?
  • What are the priority candidates for automation?
  • Example use cases and benefits.
  • Best practices for making automation a reality.
15:15 - 15:45 30 mins
Filing Variations
Extended Q+A with speakers from end of day
15:15 - 15:50 35 mins
Info
RIM & IDMP Compliance
Case study: How to prepare your RIM system for the Falsified Medicines Directive (FMD) using IDMPCase study: Leveraging ERP-RIMS linkage for Falsified Medicines Directive (FMD)
  • Hans van Leeuwen - Executive Director Regulatory Operating Platforms, Astellas, The Netherlands
  • Frits Stulp - IDMP Program Manager, Astellas, The Netherlands
  • FMD master data:
    • Current understanding of the requirements
    • Typical data (sources) and the associated challenges
  • Linking ERP and RIMS data
    • Approach
    • Outcomes
    • Challenges
  • Benefits of ERP-RIMS linkage beyond FMD
  • Next steps
15:50 - 16:20 30 mins
Networking and Afternoon Tea
16:20 - 16:55 35 mins
Info
RIM & IDMP Compliance
The RIM around IDMP: How to fill it up
  • Joel Finkle - Director, Regulatory Innovation and IDMP Strategy, Acuta
  • The IDMP data expands on the existing Article 57 (XEVMPD) requirements, requiring a deep dive into documentation
  • A Master Data approach helps bring data from across the enterprise, versus merely scratching out enough data for compliance
  • Integration between regulatory processes and RIM data can improve the value of the efforts to build IDMP
16:55 - 17:30 35 mins
RIM & IDMP Compliance
Global Rim and IDMP Systems: Pros and Cons
  • Christian Naumann - Global Regulatory Affairs Manager, Linde