First webinar on regulatory and procedural aspects of type I variations
EventCorporate
Date
- Tuesday, 15 November 2016, All day
Location
- European Medicines Agency, Amsterdam, the Netherlands
This webinar will support applicants in the preparation of the submissions of Type IA and Type IB variations to the Agency. The aim of the webinar is to present the most common validation issues identified during validation and/or processing of type IA and type IB variations to the terms of the marketing authorisation, and to increase the awareness of relevant questions and answers and guidance documents that can support applicants in the preparation of the submissions. The webinar will cover important procedural and regulatory aspects associated with IA and IB variations including electronic application form, submission requirements, update of safety product information, GMP related documentation, ASMF and other relevant topics relevant for these procedures.