Webinars

Welcome to International Cannabis and Cannabinoids Institute’s webinars. The hosts of the webinars are world-renowned cannabis experts such as Dr. Ethan Russo, Martin Masilko and Tomas Sadilek. The webinars were designed to share our expertise and secrets of the promising and magical world of cannabis.

How to register medicinal products in the EU

Lenght: 60 minutes

Wednesday September 25 2019
10:00 AM EST
11:00 AM EDT
17:00 CEST

Special price for 1st wave:
100 EUR
incl. tax

Buy

The webinar will present essential requirements (quality, non-clinical, clinical) for the successful
registration of the medicinal product in the EU

Marketing authorization (registration) of medicinal products in the EU is driven by guidelines, directives
and regulations, which are valid in all member states in the EU. Those guidelines and other legal
documents describe not only essential timelines and general requirements, but also provide relatively
detailed description of non-clinical and clinical studies, which have to be submitted along with
qualitative description and manufacturing process. This webinar will present high level overview of a
development of a new medicinal product to comply with EU requirements and will also describe
different marketing authorization procedures and “legal” types of medicinal products. The role of
European Medicinal Agency along with the National Drug Agencies will be also introduced.

Introduction to Clinical Trials

Lenght: 60 minutes

Wednesday November 27 2019
11:00 AM EST
11:00 AM EST
17:00 CET

Special price for 1st wave:
100 EUR
incl. tax

Buy

The webinar will provide an introduction to clinical trials, their types, requirements and basic principles, which are important for their successful conduction, with a particular focus on the CRO selection and management process.

Each medicinal product has to be supported by a number of clinical trials in order to apply for the marketing authorization in all countries over the world. The basic principles, how to conduct clinical trials, are being shared by regulators and number of guidance documents are published in order to provide the industry with the basic requirements. Planning of clinical trials is very detailed process and many aspects has to be taken into account, i.e. endpoints, study populations, randomization, number of subjects etc. This webinar will focus on the basic classification of clinical trials and the common principles, which are used for their planning and conduction. Also the very important process, how to select and manage CRO, will be presented.

Speakers

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. He represented the Czech Republic in The Committee for Medicinal Products for Human Use at EMA (2007-2010), while working as the Head of the Preclinical and Clinical Documentation Assessment Unit at the State Institute for Drug Control. He coordinated and provided assessment for centralized marketing authorization procedures and referrals as a rapporteur or a co-rapporteur for new active substances, biosimilar and generic medicinal products. He obtained his education in pharmacology at Charles University in Prague (MD, PhD, Prof. Assoc.), where he held the position as Head of the Pharmacology Department at the 2nd Faculty of Medicine. Martin co-founded PharmInvent in 2010 and he currently holds the position of EU-QPPV at PrimeVigilance, a specialized pharmacovigilance provider. 

Tomas Sadilek

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.

 
 
 


Newsletter

By clicking sign up I give me consent to ICCI to process my personal data for the purpose of obtaining newsletters. More information can be found HERE.

Cookies help us deliver our services and provide personalized experiences. By using this website, you agree to our use of cookies and privacy policy. More info