Who Should Attend?
This event is aimed at Regulatory Affairs staff responsible for preparing new MA applications via the abridged route. The course will benefit both experienced as well as new staff involved with the preparation and submission of new MA applications.
Benefits of attending
- Learn how to compile a perfect dossier – the art of submission
- Find out how to prepare draft responses for clock off
- Hear about the Scientific Advice Meetings and the associated benefits
- Introduction to the new initial fees calculator
- Meet the experts – face to face break-out session with selected speakers
What will be covered?
- UK as RMS, the process from submission to allocation of a timetable – roles within the Agency and points of contact
- Advice from the Information Processing Unit (IPU) on how to avoid frequent invalidation issues, eCTD format and submission routes
- Compiling the perfect dossier
- An overview of generics, choosing a suitable reference product and what’s expected from bioequivalence studies
- Hints and tips on submitting applications and responses successfully.
Delegates attending the MHRA Abridged applications symposium will be eligible to claim CPD points.