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Showing of Streams
10:55 - 11:25

Networking Break and Morning Coffee

Showing of Streams
13:10 - 14:40

Networking Lunch

Showing of Streams
15:50 - 16:20

Networking and Afternoon Tea

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
Filing Variations
Understanding the specific requirements for filing variations in Latin America/MENA/Russia & CIS/Asia/ASEAN
  • Darius-Jean Namdjou - International Regulatory Project Lead, Grünenthal GmbH, Germany
more

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
RIM & IDMP Compliance
Practical feedback on integrating manufacturing and marketing systems for effective RIM
  • Tim Powell - Associate Director, Global Regulatory Operations, Biogen
more
  • 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
Filing Variations
Case study: Practically implementing successful global variation strategies
  • Aurélie Mieze-Richard - Head of CMC-RA - Regulatory Affairs Pharmacist, Guerbet
more
  • 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?
09:45 - 10:20 35 mins
RIM & IDMP Compliance
Exploring how RIM and IDMP can be used to successfully store artwork
  • Moncef Kafi - Head of Regulatory Compliance, GUERBET, France
more
  • 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
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
more

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

10:20 - 10:55 35 mins
RIM & IDMP Compliance
Best practice for ensuring an end to end RIM Systems
  • Representative From Veeva - -, Veeva
more

· Understanding and communicating the advantages of having a single integrated RIM tool to all stakeholders

· Examining where the data is sourced from and who owns the data

· Ensuring all departments integrate efficiently and understand the role of the content they are using

10:55 - 11:25 30 mins
Networking Break and Morning Coffee
11:25 - 12:00 35 mins
Filing Variations
Regulatory authority perspective: Update on the implementation of 712/2012
more
  • Current status of 712/2012 and any upcoming plans for the future
  • Reviewing different submissions, variation types, errors and timelines that have been observed
  • Identifying key pitfalls industry show with variations under 712/2012 and how these can be overcome
  • Examining the rationale behind country-specific requirements under the regulation and implications for industry
  • Feedback and lessons learned from complex variations examples
11:25 - 12:00 35 mins
RIM & IDMP Compliance
The RIM around IDMP: How to fill it up
  • Joel Finkle - Director, Regulatory Innovation and IDMP Strategy, Acuta
more
  • 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
12:00 - 12:35 35 mins
Filing Variations
Case study: Sharing practical experiences of working with 712/2012 and overcoming key pitfalls
more
  • Clarifying how 712/2012 has influenced ways of working with variations and comparing to non-EU countries
  • Outlining strategies to ensure that variations are handled correctly under the regulation
  • Understanding and meeting country-specific requirements
  • Overcoming key challenges experienced working with 712/2012
12:00 - 12:35 35 mins
RIM & IDMP Compliance
Case study: How to prepare your RIM system for the Falsified Medicines Directive (FMD) using IDMP
  • Hans van Leeuwen - Executive Director Regulatory Operating Platforms, Astellas, The Netherlands
  • Frits Stulp - IDMP Program Manager, Astellas, The Netherlands
more
  • Best practices to ensure successful compliance with the FMD
  • How to compile data from different functions to meet FMD requirements
  •  Determining how pitfalls and challenges can be overcome
12:35 - 13:10 35 mins
Filing Variations
Comparing filing variation requirements in the EU to the US
  • Baerbel Grossman
more
  • 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


12:35 - 13:10 35 mins
RIM & IDMP Compliance
A presentation from HighPoint Solutions
  • Jens-Oalf Vanggard - Director, Research and development, Highpoint Solutions
more
13:10 - 14:40 90 mins
Networking Lunch
14:40 - 15:15 35 mins
Filing Variations
Practically implementing an effective grouping strategy for filing variations
  • Gry Agapitos - Senior Regulatory Affairs Professional, ALK Abelló, Denmark
more
  • Determining how a grouping strategy is planned, communicated and implemented
  • Outlining the key pros and cons of grouping variations
14:40 - 15:15 35 mins
RIM & IDMP Compliance
Automation in Regulatory Lifecycle Management
  • Kim Brownrigg - Associate Director, Global Regulatory Affairs, Accenture
more

- Discussing why the Regulatory industry is primed for transformation

- Defining the potential for applying automation technologies to regulatory lifecycle maintenance

- Reviewing some use cases and proof of concept demos

15:15 - 15:50 35 mins
Filing Variations
Discussing successful worksharing strategies for filing variations
more
  • How was the worksharing strategy planned, communicated and implemented?
  • Understanding how worksharing can be used for different types of application procedures (NP, DCP, MRP, CP)
  • Overcoming the key pitfalls experienced with worksharing strategies
15:15 - 15:50 35 mins
RIM & IDMP Compliance
Global Rim and IDMP Systems: Pros and Cons
  • Christian Naumann - Global Regulatory Affairs Manager, Linde
more
15:50 - 16:20 30 mins
Networking and Afternoon Tea
16:20 - 16:55 35 mins
RIM & IDMP Compliance
Understanding the FDA CMC submission standard
  • Costas Mistrellides - IDMP Regulatory Affairs Coordinator, Johnson & Johnson Consumer, UK
more
  • Updates from the FDA explaining the CMC submission standard
  • Outlining how CMC should be integrated into RIM systems
  • FDA expectations
16:55 - 17:30 35 mins
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
more
  • The challenges with CMC integration
  • Overcoming key challenges integrating CMC changes into a RIM system
  • Ensuring compliance