Registration of Medicinal Products
Every day challenges during the development and the registration of a drug are translated into practical solutions.
- Domestic and foreign regulatory bodies: which ones are there, what authority do they have, how are they organised, what are the similarities and differences?
- Different type of registration procedures for approval with FDA and Europe, what do they entail, what are the differences, lead time.
- Government counselling procedure during development.
- Regulations for clinical studies: where and how do you submit a request for approval of a clinical study.
- The language used for this module is English.
- The above topics will be illustrated in detail, using real-life cases as examples.