Regulatory Affairs in Drug Development
Master course at the Danish University of Pharmaceutical Sciences
6-10 June 2005 / The Danish University of Pharmaceutical Sciences / Copenhagen
The course objective is to give participants an overall understanding of how regulatory affairs professionals interact with the specialists involved in the process of drug development, the EU legal framework, application procedures, the strategic regulatory issues involved and how regulatory affairs professionals influence the requirements for quality, safety and efficacy - the three keys to obtaining marketing authorisation for a medicinal product.
Course directors: Karen Hørlyk, MSc (pharm), RegAdviZe, and Lars Hovgaard, associate professor, Department of Pharmaceutics, The Danish University of Pharmaceutical Sciences
Course fee: Master’s students at DFU: DKK 5,175. Freelance students: DKK 7,500. There is an additional fee for lunch and course materials