The International Cannabis and Cannabinoids Institute is proud to present its third online webinar with Martin Votava, MD, PhD, Prof. Assoc, on the 25th of September, 2019. The title of the webinar is: How to register medicinal products in the EU.
After this webinar, participants will:
1) Understand what types of marketing authorizations are legal in the EU
2) Know where to find and how to interpret scientific guidelines
3) Understand the steps involved in a typical new drug development program
This webinar will present essential requirements (e.g. quality, non-clinical, clinical, etc.) for the successful registration of a medicinal product in the EU.
Marketing authorization (i.e. registration) of medicinal products in the EU is driven by guidelines, directives, and regulations which are valid in all member states in the EU. These guidelines and other applicable legal documents describe not only essential timelines and general requirements, but also provide detailed descriptions of non-clinical and clinical study data which must be submitted along with the qualitative description and manufacturing process details of the medicinal product. This webinar will provide a high-level overview of how to develop a new medicinal product that complies with EU requirements, and will also describe different marketing authorization procedures and the legality of different types of medicinal products. The roles of the European Medicines Agency (EMA) and national drug agencies will also be addressed.
The webinar takes place on the 25th of September, 2019 at:
- 10:00 AM EST
- 11:00 AM EDT
- 17:00 CEST
You can register for the webinar at the following link for 100 euro: ICCI Webinars
Furthermore, the International Cannabis and Cannabinoids Institute is proud to present its fourth online webinar with Martin Votava, MD, PhD, Prof. Assoc, on the 27th of November, 2019. The title of the webinar is: Introduction to Clinical Trials. More info...
Biography: Martin Votava, MD, PhD, Prof. Assoc.
Martin Votava, MD, is an expert in pharmacology and regulatory science. Dr. Votava co-founded PharmInvent in 2010, and he currently holds the position of European Union Qualified Person Responsible for Pharmacovigilance (EU-QPPV) at PrimeVigilance. While working as the Head of the Preclinical and Clinical Documentation Assessment Unit at the State Institute for Drug Control, Martin represented the Czech Republic in the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) from 2007-2010. In his role as rapporteur and co-rapporteur of the CHMP, he coordinated and provided assessments for centralized marketing authorization procedures, and referrals for new active substances, biosimilars and generic medicinal products. Martin obtained his pharmacology and medical degrees at Charles University in Prague, where he subsequently was Head of the Pharmacology Department at the 2nd Faculty of Medicine.