22. - 25.07.2008
Mannheim: Certified Regulatory Affairs Manager
On this four days seminar, Dr. Hiltrud Horn gave an intensive three days training course on regulatory requirements in Europe and US. The participants received a detailed insight into all regulatory documents to be prepared for regulatory submissions (Clinical and Quality part of the dossier). She covered the various phases of drug development and post-submission activities. Dr. Horn explained to all attendees how to organize and plan meetings with Authorities and how to stay compliant with the regulatory requirements.
(Conference organized by IIR)
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