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The one-day course "Fundamentals of EU Regulatory Affairs" is suitable for everyone who is new to the field of (EU) Regulatory Affairs. During the course you will get a comprehensive overview of the EU eCTD dossier. Furthermore you will get acquainted with the most common EU procedures for a Marketing Authorization Application, such as the Central Procedure, Decentralized Procedure and Mutual Recognition Procedure. Last but not least, you will learn how to maintain your eCTD dossier via the most common procedures in the EU.
What will you learn?
After this course you will be able to:
Have a general overview of the EU-eCTD dossier
Name the various EU procedures for Marketing Authorization Application and having a comprehensive overview of the timelines of each of these procedures
Name the most common variation procedures and know how to classify your variation in accordance with relevant guidelines
Have a comprehensive overview of which dossier parts may affect each other in case of a variation
Who should attend?
Everyone who is new in the field of EU-Regulatory Affairs or professionals that want to renew their knowledge regarding EU procedures are welcome to apply.
Examination
For this course no examination takes place. You will receive a certificate of attendance after the course.
Course date
Monday October 26th 2020
08.30 - 17.30
Networking drinks are offered from 17.30 to 18.30
Venue
Meeting Plaza Utrecht CS
Godebaldkwartier 357
3511 DT Utrecht
Subscription fee
This course will be charged at € 749,- per candidate. Early bird subscribers (before April 30th 2020) will be rewarded with a discount of -20%!
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