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 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.
In order to obtain the additional certificate, the
applicant must attend 3 courses / conferences of the following choice:
- CEFIC/APIC European Conference on APIs -
Regulatory Affairs Part
- CTD, CEP and DMF - Quality of Drug Substance
- Validation of Microbiological Test Procedures
- Validation of Analytical Test Procedures
- Reference Standards
- Stability Testing
The following link leads you to upcoming
events recognised for the
Certified
Regulatory Affairs Manager (ECA).
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