Regulatory and Scientific Affairs Conference

The 19th Regulatory and Scientific Affairs Conference, organized by Medicines for Europe will be in the Hilton Hotel in Amsterdam.

Top agenda topics

  • New EU political landscape – how will it impact the pharmaceutical regulatory environment?
  • Why is it the right time now to review the EU Variations Regulation?
  • Regulatory measures to respond better to issues of medicines shortages
  • Road Map towards an electronic patient information leaflet
  • From document to data driven process- is the regulatory environment ready?
  • Streamlining global development of generic medicines: hope vs. hype
  • Is the current regulatory framework supportive of developing more complex off-patent medicines?

Remco Munnik, Associate Director at Iperion and chair of the Telematics Working Group in Medicines for Europe, is one of the speakers during the session on:

Telematics – Regulatory affairs fitting with the Digital age – From eCTD to data submission.

The objective of the session is to investigate what opportunities digital technology can bring to the Regulatory Network to address current operational challenges and improve the is it still a
dream?efficiency of the Regulatory processes. An update on the current Telematics projects will be part of the session.

  • Digital Technology and automation – what opportunities are there for the Regulatory environment?
  • Regulatory Network readiness to move from a document to a data driven process
  • Telematics Agenda 2020-2021: what directions are we going to take?
  • Multi-stakeholders’ collaboration – Discussing the why, what and how to move quickly towards the Digital Regulatory era.

Other speakers in this session are: Isabel Chicharo (EMA), Georg Neuwirther (AGES), Peter Bachmann (BfArM), Anjana Pindoria (Extedo) and Stuart Izod (Teva)

More information and subscribe


30 - 31 Jan 2020


Medicines for Europe


Medicines for Europe

Leave a Reply

You must be logged in to post a comment.