The ICCI - 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.
This webinar will provide an introduction to clinical trials, including an overview of the types, requirements and basic principles which are important for conducting a successful clinical trial. Effective selection and management of a Contract Research Organization (CRO) will also be addressed.
In order to apply for a marketing authorization, all medicinal products must have supporting data from clinical trials. Regulators have outlined the basic principles of how to conduct clinical trials, and a number of guidance documents are available to provide industry with information on the basic requirements. Planning a clinical trial is a complex process, with many details that need to be taken into account (e.g. design, outcomes, endpoints, study populations, number of subjects, randomization etc.). This webinar will focus on describing types of clinical trials, their attributes, and the common principles which are used for successful planning and execution. Also, information on selecting and managing a CRO will be presented.
After this webinar, participants will:
1) Understand different types of clinical trials
2) Understand how to plan a clinical trial (e.g. design, target population, objectives, endpoints etc.)
3) Understand how to select the most suitable Contract Research Organization (CRO) for their needs
The webinar takes place on the 27th of November, 2019 at:
10:00 AM EST
11:00 AM EDT
You can register for the webinar at the following link for 100 euro: ICCI Webinars
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.