The 22nd Medicines for Europe Regulatory Affairs and Pharmacovigilance Conference will take place in Brussels on 27-28 September 2023!
With the recent publication of the European Commission proposal for a new pharmaceutical legislation, this Conference will be a timely and unmissable opportunity for attendees to be informed about the new legislative proposal and its impact on future day-to-day regulatory operations and on the long-term implications for the off-patent sector in the coming decades.
The conference will bring together key stakeholders, including leading regulators, industry experts, and European institution officials, to engage in discussions and debates on the regulatory challenges and opportunities that lie ahead.
Highlighted areas of discussion on the revision of the pharmaceutical legislation include:
- Meeting the objectives of Access, Affordability, and Availability of Medicines
- Facilitating Timely Entry of Generic and Biosimilar Medicines
- Reflection on New Obligations for Marketing Authorisation Holders
- Achieving Regulatory Efficiency
- Ensuring Benefits of Digitalisation
The EU Green Deal and its Impact on the Pharmaceutical Regulatory System will also be presented and discussed.
The conference will end with a special Q&A session and an opportunity to address questions to the European Regulators on various regulatory issues.
In addition, participants will have access to three on-line technical webinars focusing on :
- the latest developments in the pharmacovigilance space
- the implementation of the new Medical Device Regulation and several initiatives to bring the worlds of pharma and medical devices closer
- the latest developments in EU Regulatory Network IT projects, including PMS, ePI Pilot, eAF for variations.
Don’t miss this opportunity to join regulators, industry experts and policymakers in a lively debate on the future of regulatory affairs in the European pharmaceutical industry