Last update: doc. MUDr. Jiří Slíva, Ph.D. (21.06.2017)
The subject is organised in form of seminars (see the syllabus)
Requirements to the exam
Last update: doc. MUDr. Jiří Slíva, Ph.D. (21.06.2017)
Not applicable
Syllabus
Last update: doc. MUDr. Jiří Slíva, Ph.D. (21.06.2017)
1. Establishing bio-equivalence between generic and innovator products 2. Clinical development of locally applied products 3. Clinical development of respiratory products 4. Product Development of peptides, biosimilars and vaccines 5. Clinical Development of injectable products 6. Good Clinical Practices 7. Drug Safety (Pharmacovigilance) - Regulatory Challenges with key differences between EU, US and ROW
Entry requirements
Last update: doc. MUDr. Jiří Slíva, Ph.D. (21.06.2017)
Not specified.
Course completion requirements
Last update: doc. MUDr. Jiří Slíva, Ph.D. (21.06.2017)