Marketing Authorization (MA) procedures in light of the EU Pharmaceutical Legislation Reform
WEBINAR WILL BE RECORDED
WEBINAR DETAILS
About
Join us as we unravel the historical legislative changes that have shaped the pharmaceutical industry and explore the visionary future pharmaceutical strategy for Europe. Delve into the upcoming reform of EU pharmaceutical legislation, understanding its objectives, timelines, and impact on the EU Marketing Authorization (MA) regulatory framework. Discover how the planned changes will impact expectations regarding compliance with legislation requirements imposed on Marketing Authorization Holders, covering various aspects of MA such as new procedural improvements and simplifications, as well as dossier or pharmacovigilance information. This webinar aims to provide a comprehensive and concise overview of the expected changes to the European strategic approach, ensuring you stay ahead in navigating the evolving pharmaceutical landscape.
Agenda
History of changes to EU Pharmaceutical Legislation
Reform of the EU Pharmaceutical Legislation
Impact on the EU Marketing Authorisation (MA) regulatory framework - Current vs. Proposed
Q & A
Price
Free
Language
English
OPEN TO
Anyone with the event link can attend
Dial-in Number
Please register for this Webinar to view the dial-in info.
Senior Regulatory Affairs Specialist, MAA and Maintenance
Marina's Regulatory Affairs career spans two decades within the pharmaceutical industry of mostly generics. She has been working on pre- and post-approval activities related to regulatory applications. Her expertise includes the preparation and...
Associate Director of Regulatory Affairs, MAA and Maintenance
In PrimeVigilance, Katarina currently serves as the Associate Director of Regulatory Affairs, MAA and Maintenance Unit, where she offers senior oversight for projects involving marketing authorization applications (MAA) and a broad spectrum of...
PrimeVigilance, an Ergomed company, has grown to become the leading Pharmacovigilance specialist company, delivering global solutions for clinical safety and post-marketing pharmacovigilance and medical information from our operational hubs based...