Variations to Marketing Authorisations is a course dedicated to the EU system for variations, with practical advice on the preparation and submission of variation applications using the various European procedures.
Topics
How pharma companies are working in this evolving regulatory environment
The EU system for variations
The impact of Module 3 on your variations dossier
The preparation and submission of variation applications
Filing tips and strategies to help achieve faster approval
Who should Attend
Anyone with an involvement in the variations process including clinical safety, QA and pharmacovigilance
Those working in registration and regulatory affairs
