Marketing Authorization of Medicinal Products: guarantee of efficacy, safety and quality of medicinal products?

21.3.2012


The lecture will take place from 3:00pm till 5:30pm.

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

Mgr. Michal Burger

Faculty of Medicine of Masaryk University

M.D.  Jiřina Petrželková

M.D. Jiřina Petrželková

Faculty of Medicine of Masaryk University

M.D. Jitka Vokrouhlická

M.D. Jitka Vokrouhlická

SÚKL (State Institute for Drug Control)

Fee

The lecture is free.

Contact

The course is intended for physicians, academics, Ph.D. students and other professionals.
Boardroom deanery LF MU, Brno University Campus Bohunice, Hall 17 A, 4th NP, room 432

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