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
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Reviews by course attendees
Average rating 4.6
It was very interesting and informative.
Excellent webinar! [Speaker is] engaging and friendly.
Excellent presentations and course material. Always better face to face, but digital plateform worked well. All very clear. Alot was covered during two days. The case studies ma...