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May 18
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08:00 - 08:50 50 mins
Main agenda
09:00 - 09:40 40 mins
European Regulatory Affairs Forum
EU eSubmissions Roadmap: what is upcoming and when for eSubmissions in Europe?
  • Mickel Hedemand - Special Advisor, Danish Medicines Agency
  • Overview of the EU eSubmissions Roadmap
  • Exploring the timelines and milestones involved with the Roadmap
  • Understanding the commitment to eCTD and its implications
  • Determining the impact on industry and expectations that come with the Roadmap
09:40 - 10:20 40 mins
European Regulatory Affairs Forum
Examining upcoming changes for the eCTD
  • Dr Baerbel Grossman - Senior Manager Regulatory, Sanofi
  • Assessing the upcoming changes in the requirements by the authority
  • Understanding timeframes for different countries in terms of submissions
  • Clarifying the steps needed to comply and achieve a baseline dossier
10:20 - 10:50 30 mins
Main agenda
Morning Break
11:00 - 11:40 40 mins
European Regulatory Affairs Forum
Panel Discussion: Portfolio Lifecycle Management – challenges and opportunities
  • Dr Meike Vanhooren - Senior Director, Pfizer
  • Horst Kastrup - Senior Regulatory Advisor, Meda Pharma
  • Exploring and comparing efficient approaches to product lifecycle management
  • Reviewing the challenges and opportunities – complexity linked to requirements of keeping dossiers up to date in differing member states
  • Examining whether initiatives like ICH can refute the burden of variation submissions
11:40 - 12:10 30 mins
European Regulatory Affairs Forum
IDMP and other reasons why your labeling content deserves stuctured authoring
  • Volker Stocker - Sales Pharma, SCHEMA Group

The upcoming IDMP implementation casts a long shadow on Regulatory Affairs departments. Pharma companies have learned that their labeling content could be a good source for IDMP records. But how to combine the flexibility of Word documents with the rigidity of the IDMP data model? What can structured authoring do for you? And why can this solution also be a remedy for other headaches in global labeling?

12:10 - 13:30 80 mins
Main agenda
Networking Lunch
13:30 - 14:10 40 mins
European Regulatory Affairs Forum
Filing variation submissions: advice for industry
  • Mickel Hedemand - Special Advisor, Danish Medicines Agency
  • Examining agency specific preferences for variation types
  • Exploring the reasons behind dossier rejections in particular countries and what can be done to overcome it
  • Addressing agency actions to increase harmonisation on variation assessments between assessors and between European agencies
  • Understanding the need and rationale behind country specific requirements/paperwork
14:10 - 14:50 40 mins
European Regulatory Affairs Forum
Communicating risks to patients and examining usability and readability of the SmPC and PIL
  • Em Stevens - Manager Global Regulatory Affairs, CoE Pharmaceuticals, B.Braun Medical
  • Exploring how to best translate terminology between healthcare professionals and patients 
  • Practically implementing an improved level of readability for patients and healthcare professionals 
  • Exploring current labelling guidelines and how to achieve compliance
14:50 - 15:20 30 mins
Main agenda
Afternoon Refreshments
15:20 - 15:50 30 mins
European Regulatory Affairs Forum
Examining the current status of the Falsified Medicines Directive and its impact on industry
  • Johan Verhaeghe - National Policy Liaison, Medicines for Europe
  • An overview of Commission Delegated Regulation (EU) 2016/161
  • Examining the timelines for implementation in the EU and globally
  • Assessing the impact of the Regulation on serialisation requirements
  • Reviewing best practices of preventative measures for counterfeits
15:50 - 16:20 30 mins
European Regulatory Affairs Forum
Facilitate the implementation of the EU Falsified Medicines Directive using GS1 standards: serialisation and marking requirements
  • Ulrike Kreysa - Vice-President Healthcare, GS1
  • Overcoming new requirements for coding and marking
  • Assessing the impact of serialisation on the supply chain
  • Adapting pre-existing packaging in the national market and multi-market packs
  • Examining serialisation requirements around the globe – where GS1 standard can support implementation?