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.
For questions relative to the ECA Certified Regulatory Affairs Manager,
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".
- The Regulatory Compliance Expert
- CTD, CEP and Active Substance Master File
- Annual APIC/CEFIC European Conference on Active Pharmaceutical Ingredients,
Regulatory Affairs Part
- Getting approval of Generics in the EU and the US
- Drug Master File Procedures in the EU, USA and Japan
- How to write the Quality Part of an IMPD
- Handling Changes and Variations
>>> LIST OF ALL COURSES AND CONFERENCES CURRENTLY OFFERED AND ACKNOWLEDGED IN THIS PROGRAMME (including detailed information on every event – venue, dates, fees and agenda as PDF; just click on any event in the list)