Marketing Authorization of Medicinal Products: guarantee of efficacy, safety and quality of medicinal products?
Wed 21 Mar
|Bohunice
No medicinal product may be launched without the decision on marketing authorization granted by the national authority or by the European Medicines Agency. Marketing authorization is the basic prerequisite for standard medicinal product entering the market in CR and EU.
Čas a místo
21 Mar 2012, 09:00
Bohunice, Kamenice 5, 625 00 Bohunice, Czech Republic
O události
No medicinal product may be launched without the decision on marketing authorization granted by the national authority or by the European Medicines Agency. Marketing authorization is the basic prerequisite for standard medicinal product entering the market in CR and EU.
How does the “marketing authorization” of medicinal products in CR and within the EU countries proceed? What documentation has to be submitted and how is it assessed? What are the differences between marketing authorization of the original and the generic medicinal product and what is their definition? What are specific features of marketing authorization of the medicinal products from the group "biosimilars"? How does the simplified marketing authorization procedure run for traditional herbal medicinal products and homeopathic remedies? Why do the medicinal products with the same active substance have different approved indications? The lecture should answer these and other questions.
Lecturer
Mgr. Michal Burger Faculty of Medicine of Masaryk University
M.D. Jiřina Petrželková Faculty of Medicine of Masaryk University
M.D. Jitka Vokrouhlická SÚKL (State Institute for Drug Control)
Fee The lecture is free.
Contact
Bc. Eva Bláblová, eblablo@med.muni.cz | +420 725 828 348 | +420 549 49 7039
The course is intended for physicians, academics, Ph.D. students and other professionals.
Place
Boardroom deanery LF MU, Brno University Campus Bohunice, Hall 17A, 4th floor, romm 432