ECA Certified
Regulatory Affairs Manager

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. Due to the rapidly growing numbers of new and revised guidelines they also need to update this knowledge frequently. Depending on the main emphasis of their activities, they also have to acquire diverse qualifications. The seminars and conferences of this programme take this into account.

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".

  • Global Registration and Life Cycle Management of APIs
  • GMP meets Regulatory Affairs
  • API Regulatory Starting Materials
  • How to write the Quality Part of an IMPD
  • Handling Changes and Variations
  • How to provide process validation data in regulatory submissions
  • Quality by Design in API Manufacturing
  • Drug Master File Procedures in the EU, the US and Japan

Your Questions

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

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