Conferences - GMP Certification Programme

ECA Certified Regulatory Affairs Manager

Regulatory Affairs Managers are internal specialists for various regulatory affairs and regulatory compliance topics. For this task, they need a wide-ranging knowledge. Depending on the main emphasis of their activities, they have to acquire diverse qualifications. The seminars and conferences of this programme take this into account.

 

Your Questions

For questions relative to the ECA Certified Regulatory Affairs Manager, please contact heimes@gmp-compliance.org.

Courses and Conferences acknowledged

To receive the certificate, the applicant must attend three out of the following courses / conferences. After attending the third course, the applicant obtains the certificate "ECA Certified Regulatory Affairs Manager".

• CTD, CEP and Active Substance Master File
• Annual APIC/CEFIC European Conference on Active Pharmaceutical Ingredients, Regulatory Affairs Part
• Marketing Authorisation Procedures in the EU
• Marketing Authorisation Procedures in the US


• How to write the Quality Part of an IMPD


• Handling Changes and Variations

To get to the calendar with all courses and conferences currently offered for this programme - including a link to the contents and a booking form - please go here.