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Fundamentals of EU Regulatory Affairs

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.

Programme

For an overview of the programme click here.

 

 

 

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%!

Subscribe now via academy@interdos.nl

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Phone: +31 (0)88 255 40 60
You can report suspected adverse drug reactions / side effects of our medicines by sending an email to: pv@interdos.nl

In case of urgent safety issue please contact us: +31 (0)6 511 68 061
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