LinkedIn live session: Improving efficiency of approval process for new medicines in the EU
EventHumanMedicines
- The original event time is:
- Thursday, December 5, 2024 - 12:30 - 13:30 Amsterdam time (CET)
Date
- , -
Location
- OnlineLive broadcast
Event summary
EMA is organising a LinkedIn live session with Francesca Day, EMA's head of therapeutic areas, and Alessandro Faia, Press Officer. The topic of the session is the predictability of submissions of initial marketing authorisation applications to EMA and how delays in this process affect the long-term planning of the entire medicines regulatory system and can delay the approval times for much needed medicines in the EU.
Only 35% of marketing authorisation applications were submitted on the agreed date in 2023. EMA and the European medicines regulatory network are working to further improve efficiency in the assessment and approval processes for new medicines in the European Union. The initiative aims to better manage the use of the network's expert resources, streamline assessment processes and encourage better and more comprehensive application dossiers from applicants at the time of initial submission.
The Linkedin live session will explore the challenges companies face in meeting their intended submission dates, and how can they improve their planning, the measures recommended, and the tools provided by EMA to help improve the planning of marketing authorisation applications.
All live viewers are encouraged to participate and ask questions via the comment section. Questions related to the topic can also be sent in advance of the event by email to press@ema.europa.eu and will be answered on 5 December.