Understanding European medicine registration requirements and procedures Understanding European medicine registration
requirements and procedures
Who Should Visit?
Executives
Managers
Assistants
Officers
Associates
Important Topics
Explore key updates to European regulatory affairs and identify key regulatory institutes
Learn how to construct your submissions in CTD format
Speed-up your drug submissions by selecting the most appropriate EU registration procedure
Update on new Pharmacovigilance Legislation and ensure you meet post-approval obligations to keep your marketing authorisation valid
Evaluate extra considerations required for registering pharmaceuticals in the USA
Benefits Of Visiting
Understand the basis of EU legislation
Speed-up the MAA through effective selection of your drug registration Compile and present the key information in your submission dossiers more efficiently
Improve your dossier compilation process through a systematic data collection strategy
Allow a smooth product development programme
Gain faster response from the Regulators through better negotiations
Maintain your marketing authorisations by performing postapproval obligations on time
Other Highlights
Increase communication and performance by training your department as a team
Save valuable time and expenditure
Address your teams’ specific needs with a tailored training approach
