Syllabus
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
Annotation
The fundamental principles of the process of drugs development in EU and other countries will be comprehensively described and discussed.