Dr. Laure Bidois of Cyton's Regulatory Procedures Group, is joined by four other expert presenters from industry and the European regulators to deliver a comprehensive overview of how to prepare and submit variations to VMP marketing authorisations in the EU.
Full details of the event can be found on TOPRA's website (link below), but in brief, this event will cover all aspects of variation submissions, including variation categorisation, grouping and work-sharing. Quality, safety, efficacy and pharmacovigilance changes will all be addressed.
Meet Cyton's Regulatory Procedures Expert
Dr Bidois will be presenting at this training event. If you would like to discuss Cyton's services informally with Laure, please feel free to get in touch beforehand or at the event.