New Year – New you for E.U. pharmaceutical legislations?

Not quite. While legislative proposals such as the one for Substances of Human Origin (SoHOs) have reached an agreement that still needs to be voted on, others such as the general pharmaceutical legislation are under fierce debate. There are several legislative proposals at various stages including additionally the EMA fees, the European Health Data Space and actions to solve the medicines shortages situation being discussed by E.U. legislative bodies.
Bring some popcorn as we look at an overview of the status of each of these, legislative decision timeline as far as available and discuss the controversial topics being debated by E.U. legislative bodies.
For example, the pharmaceutical legislation received about 2.5k amendments for each the proposed directive and regulation. We will discuss the spread of opinions on some of the most contentious issues such as regulatory protection, transferable exclusivity vouchers and market launch requirements and how any adopted option could potentially impact pharmaceutical industry.
But there is more: The European Parliament is up for election in June this year.  How might this affect things?

 SPEAKER BIO:

Kirsten Messmer, PhD, RAC is a Senior Research Analyst and contributes to the research and development of content for Agency IQ on regulatory issues for the United States and the European Union.
Prior to joining Agency IQ, she was a Principal Regulatory Affairs Specialist at PPD providing global regulatory intelligence to support efficient, compliant and successful clinical research and drug development for biopharmaceuticals and advanced therapies.
Before starting at PPD, Kirsten worked at Theradigm to develop stem cell therapies for neurodegenerative diseases before joining ERA Consulting. She held post-doctoral fellowships in London and Baltimore.
Kirsten received her PhD in Neuroscience from the University of Sheffield (Sheffield, UK) and a Biology Diplom from the Eberhard-Karls University (Tübingen, Germany). She also holds a Regulatory Affairs Certification (RAC) in US regulation.

EVENT INFO:

Join the North Carolina Regulatory Affairs Forum (NCRAF) for our first event of the new year! For in-person attendees, there is a networking reception from 5:30-6:30.  The hybrid seminar presentation will be held from 6:30-8, including an open floor for audience questions. Thank you to IQVIA for generously providing the event space to support this educational forum!

Register for this event below. The event is free for all NCRAF members (standard as well as student/post-doc/unemployed jobseeker). For non-members, registration is $20.

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