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08:00 - 09:00

Registration

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Showing of Streams
10:55 - 11:20

Coffee and Networking Break

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Showing of Streams
12:30 - 14:00

Networking Lunch

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Showing of Streams
15:40 - 16:10

Networking and Afternoon Tea

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Showing of Streams
17:15 - 17:25

Closing Remarks

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17:25 - 18:55

Networking Drinks

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08:00 - 09:00 60 mins
Registration
09:00 - 09:10 10 mins
Global eSubmissions
Operning Remarks
09:00 - 09:10 10 mins
Regulatory Information Management
Opening Remarks
09:10 - 09:45 35 mins
Info
Global eSubmissions
EU National Submissions – An overview of Pfizer’s experience
  • Daniel Verrall - Senior Team Manager, Pfizer, UK
  • Grandfathering of eCTD Products in preparation for Brexit
  • Requirements and challenges
  • Pfizer’s approach to Grandfathering
  • Post Brexit planning for eCTD Submissions


09:10 - 09:45 35 mins
Info
Regulatory Information Management
Feedback on EMA's IDMP Implementation Guidelines
  • Laurent Desqueper - XEVMPD & IDMP Business System Owner, MSD Europe Inc, Germany
  • Reviewing EMA’s implementation guide, the defined items, and timelines
  • Understanding the importance of the IDMP Implementation Guidelines for a successful transition to IDMP
  • Designing a strategic implementation plan
09:45 - 10:20 35 mins
Info
Global eSubmissions
Regulatory Agency Perspective: Feedback, plans and practical advice for eCTD submissions moving forward
  • Jaana Pohjonen - Specialist of Record Management and Archives, Quality Manager, FIMEA, Finland
  • Exploring current telematics timelines
  • Discussing common pitfalls during eSubmissions process and how they can be avoided
  • Case Studies on handling industry data
09:45 - 10:20 35 mins
Info
Regulatory Information Management
Lessons Learned from Data Migration
  • Danielle Beaulieu - Director, Global Regulatory Business Capacities, Bristol-Myers Squibb, USA
  • Case study: end-to-end execution of data migration
  • How best to maintain data quality during migration?
  • Common problems faced during the migration process
10:20 - 10:55 35 mins
Info
Global eSubmissions
An Update on Clinical Trial Applications in the EU
  • Abby Cottage - Regulatory Operations Manager, Amgen Ltd
  • Current and projected timelines for the EU CTA
  • Working through the Clinical Trial Regulation and submissions portals
  • Discussing best practice for the incorporation of clinical trial submissions into eCTD
10:20 - 10:55 35 mins
Info
Regulatory Information Management
Improving Data Integration Across the Business
  • Marty Boom - Global Head of Regulatory and Safety, Navitas Life Sciences, Germany
  • Discussing the significance of information integration
  • Data integration implementation best practice
  • Current challenges in cooperation across departments
10:55 - 11:20 25 mins
Coffee and Networking Break
11:20 - 11:55 35 mins
Info
Global eSubmissions
Best Practice for Implementing the EU Falsified Medicines Directive
  • Johan Verhaeghe - National Policy Liaison, Medicines for Europe, Belgium
  • FMD, quo vadis?
  • Intro for those who lived on Mars: what, when, where and why of FMD + DR

  • Experience since deadline (2 months)

  • changes compared to live as we used to know it before FMD

  • Lessons learned so far?

  • And now?





11:20 - 11:55 35 mins
Info
Regulatory Information Management
Data Modelling for Regulatory Affairs
  • Jörg Stüben - Senior Expert in Global Regulatory Operations, Boehringer Ingelheim Pharma GmbH & Co KG, Germany
  • Exactly know what you have
  • Understand the end to end relationship within the lifecycle of those data
  • Avoid data redundancies
  • Improve data quality
  • Form the prerequisite for any proper digitalization activities.
11:55 - 12:30 35 mins
Info
Global eSubmissions
Experiences of Submitting Dossiers in China
  • Sophia Huang - Head of Regulatory Submission Management & Planning Beijing, Bayer Healthcare Company Limited
  • Industry experience of submitting in China
  • Reflection on the changes in the regulatory environment
  • Updates on eCTD adoption status and trends
11:55 - 12:30 35 mins
Info
Regulatory Information Management
Utilising AI and Data Analytics to Optimise your Regulatory Strategy
  • Jim Nichols - COO, Cunesoft
  • How you can use AI to get more out of your existing data
  • Exploring the impact of AI on the regulatory submissions process
  • Defining and understanding the main challenges for stakeholders
12:30 - 14:00 90 mins
Networking Lunch
14:00 - 14:35 35 mins
Info
Global eSubmissions
Assessing the Latest Developments Towards eCTD in Singapore
  • Speaker to be Announced, .
  • Outlining the current regulatory review process and good review practices
  • Updates on eCTD adoption in Singapore
  • Discussing common submission pitfalls
14:00 - 14:35 35 mins
Info
Regulatory Information Management
Industry Case Study: Cross Functional Collaboration – Data Integration Across the Business
  • Patrick Middag - Associate Director, Regulatory IT, Bristol-Myers Squibb, Belgium
  • Deborah McCloskey - Global Regulatory Business Capabilities Director, Bristol-Myers Squibb, USA
  • Discussing the significance of information integration
  • Data integration implementation best practice
  • Current challenges in cooperation across departments
  • Leveraging cross-functional expertise to strengthen relationships
14:35 - 15:10 35 mins
Info
Global eSubmissions
Guidance from South East Asia on the Harmonisation and Implementation of eCTD
  • Speaker to be Announced, .
  • Where do we stand with the ASEAN Pharmaceutical Harmonisation Standard?
  • Discussing the latest eCTD updates and expectations in Thailand
  • Updates and timelines from around the region
14:35 - 15:10 35 mins
Info
Regulatory Information Management
Industry Feedback on the Falsified Medicines Directive: Post Implementation
  • Quentin Grignet - IDMP – Project Lead, GSK, Belgium
  • Feedback from industry on the implementation best practice
  • Pragmatic advice on strategies for departmental data coordination
  • Case study on minimising risk and data alignment to fill potential data gaps
15:10 - 15:40 30 mins
Info
Global eSubmissions
Case Study: Implementing a Successful eSubmissions Strategy at a SME
  • Katrin Spaepen - Director Strategy Vault RIM, SMB, Veeva
  • Best practice for implementing an efficient eCTD strategy
  • Deciding factors: in-house or outsourcing? The best options for your regulatory submissions process
  • Outlining challenges and sharing experience of overcoming them
15:10 - 15:40 30 mins
Regulatory Information Management
Spotlight Session
  • Representative from Amplexor, Amplexor
15:40 - 16:10 30 mins
Networking and Afternoon Tea
16:10 - 16:45 35 mins
Info
Global eSubmissions
Outlining Current Regulatory Submission Status in Jordan
  • Reema ALotoum - Pharmacist, Jordan FDA
  • Latest updates from the JFDA including new eCTD specification
  • Outlining the current regulatory review process and good review practices
  • Discussing common pitfalls during submissions process and how they can be avoided
16:10 - 16:45 35 mins
Info
Regulatory Information Management
Designing an End-to-End RIM System
  • Costas Mistrellides - IDMP Regulatory Affairs Coordinator, Johnson & Johnson Consumer, UK
  • Chris Dunn - IDMP Specialist, Johnson & Johnson, UK
  • Understand the increasing importance and roles of RIM systems within organizations
  • Formulating a foundational RIM strategy
  • Operational hurdles for smaller companies
16:45 - 17:15 30 mins
Info
Global eSubmissions
Updates on Submissions in Australia
  • Henrietta Dehmlow - Head of Submission Management, Roche, Switzerland
  • Discussing regulation changes out of the TGA in Australia
  • Sharing practical experiences of successful submissions
  • Outlining challenges and sharing experience of overcoming them
16:45 - 17:15 30 mins
Regulatory Information Management
Panel: The Future of Information Management - Shifting the Mindset from Tactics to Strategy
  • Jörg Stüben - Senior Expert in Global Regulatory Operations, Boehringer Ingelheim Pharma GmbH & Co KG, Germany
  • Frits Stulp - Project Manager EU-SRS, Medicines Evaluation Board
17:15 - 17:25 10 mins
Closing Remarks
17:25 - 18:55 90 mins
Networking Drinks