Variations to Marketing Authorisations
It is a key post-marketing responsibility of the marketing authorisation holder (MAH) to keep dossiers up to date, and changes must be submitted as variations to the appropriate regulatory authority.
This interactive event will provide an invaluable overview of the EU system for variations, with practical advice on the preparation and submission of variation applications using the various European procedures. The course will cover the latest variation regulations and offer guidance from an industry expert on how to optimise your regulatory procedures to help achieve faster approval. The programme will include filing tips and strategies with information and advice on creating a global dossier and implementation periods.
Practical sessions throughout the two days will provide an opportunity to discuss different scenarios and strategies with other participants.
Benefits of attending:
- Gain an overview of the EU system for variations
- Assess how pharma companies are working in this evolving regulatory environment
- Profit from practical advice on the preparation and submission of variation applications
- Understand the impact of Module 3 on your variations dossier
- Discuss filing tips and strategies to help achieve faster approval
Upcoming start dates
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Reviews by course attendees
Average rating 4.7
Really good. The speakers did a wonderful job explaining everything.
The presentation was great and the speakers have excellent knowledge on their field. I hope to join another webinar soon.
About IPI Academy
International Professional & Industry Academy (IPI) is an international leading professional training organisation based in London. Our training solutions provide a return on your investment with measurable results, and are delivered by experienced professionals and managed with exceptional care and...
The webinar content corresponded to what I was expecting ; I thought it was very good that Andrew asked the participants lots of questions as it made the webinar more enjoyable ...