Welcome to International Cannabis and Cannabinoids Institute’s webinars. The hosts of our webinars are world-renowned cannabis experts such as Dr. Ethan Russo, Tomas Sadilek and Dr. Martin Votava. The webinars are designed to share our expertise and secrets of the promising and magical world of cannabis.
Introduction to Clinical Trials
Lenght: 60 minutes
Wednesday November 27 2019
Special price for 1st wave:
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
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.
Ethan Russo, MD
Ethan Russo, MD, is a board-certified neurologist, psychopharmacology researcher, and Director of Research and Development for the International Cannabis and Cannabinoids Institute. Previously, he was Medical Director of PHYTECS, 2015-2017, and from 2003-2014, he was Senior Medical Advisor, medical monitor/study physician to GW Pharmaceuticals for numerous Phase I-III clinical trials of Sativex® and Epidiolex®. He graduated from the University of Pennsylvania, and the University of Massachusetts Medical School, before residencies in Pediatrics in Phoenix, and in Child/Adult Neurology at the University of Washington, Seattle. He was a clinical neurologist in Missoula, Montana for 20 years. He has held faculty appointments in Pharmaceutical Sciences at the University of Montana, and in Medicine at the University of Washington.
Ethan is a former president of the International Cannabinoid Research Society and former Chairman of the International Association for Cannabinoid Medicines. He is author/editor of seven books on cannabis and medicinal herbs, and has also published numerous book chapters, and over fifty articles in neurology, pain management, cannabis, and ethnobotany.
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.
Tomas Sadilek joined the ICCI in the position of Director of Government Affairs. He brings with him extensive experience from the Office of the Government of the Czech Republic in the field of Legal and Illegal Drugs. Tomas represented the Czech Republic in all drug-related meetings in the United Nations institutions (Vienna, New York). Furthermore, he represented the Czech Republic in meetings in the EU area, Eastern Partnership countries area, occasionally the US; these being related to UN meetings, Council of the EU meetings and Council of Europe meetings.