ECA Certified Regulatory Affairs Manager

Regulatory Affairs Managers are 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.

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”.

  • GMP meets Regulatory Affairs
  • API Regulatory Starting Materials
  • Drug Master File Procedures in the EU, the US and Japan
  • ICH Q12
  • Global registrations and Life Cycle Management for APIs
  • How to write the Quality Part of an IMPD
  • Handling Changes and Variations
  • APIC/CEFIC European Conference on Active Pharmaceutical Ingredients, Regulatory Affairs Part
  • How to provide Process Validation Data in a regulatory submission

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