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.
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.
Regulatory Outsourcing Options
Cyton’s dedicated regulatory procedures team can support you with:
- Dossier preparation, submission & regulatory procedures
- Regulatory intelligence and strategic planning
- Life cycle management
- Key person cover
- Pharmacovigilance
- Brexit support services
Cyton Germany is now open for business!
Providing all the services available from Cyton UK, the new office ensures business continuity, post Brexit and beyond, for Cyton and our clients.