Quality, GMP and GACP Requirements for Medicinal Cannabis and Cannabis Products in the EU and Switzerland – Status Quo (4h content) (10405)

Medicinal cannabis and respective products have been available in EU member states as single-patient prescriptions without regular marketing authorisations for a couple of years. The Netherlands was the first member state to realise this, in the meantime other member states have followed. Today, beside the Netherlands, Germany is the most important market for such products. The regulatory framework for the approval of medicinal cannabis and its distribution to patients in the EU member states is, however, not harmonised at all and there are distinct national regulations. Regarding the quality of such products, the general requirements for herbal medicinal products as defined in the European Pharmacopoeia, national pharmacopoeias and the EMA guidance documents in place beside GMP requirements in the EU are applicable. However, for a couple of aspects every EU member state follows its own interpretation of these requirements.

Non-medicinal borderline products with low THC or based on CBD are marketed with health or well-being promoting claims in a regulatory grey zone. For these products as well there are quality requirements, or those requirements should at least be requested.

The webinars aims to provide an overview regarding the current requirements regarding CMC and GMP in EU member states and Switzerland for medicinal cannabis and borderline products. Aspects regarding regulations for narcotics will not be covered by the webinars.

If you would like to book only one lecture, please follow the links below:
Webinar 1 – QA, GACP and GMP requirements
Webinar 2 – CMC requirements for flowers, extracts and products, respectively

Webinar 1 – QA, GACP and GMP requirements

• Concepts followed by EU member states for demarcation between GACP – EU GMP Part II – EU GMP Part I
• HACCP for borderline products
• Quality requirements for medical devices
• Consequences of different concepts for importation in and distribution within the EU and related licenses needed
• Overview GACP requirements
• Overview GMP requirements | Differences EU GMP Part I and II
• Audits and Inspections - Challenges and Experiences
• GMP considerations for products used in clinical trials

Webinar 2 – CMC requirements for flowers, extracts and products, respectively

• Phytochemistry of Cannabis
• Quality requirements for CBD and borderlineproducts
• CMC requirements for herbal medicinal products and respective starting materials in the EU
• Detailed requirements for Cannabis flowers, extracts and (magistral) products
• Pharmacopeia Monographs (DAB, Ph. Helv.) and other monographs issued by authorities
• Requirements for contaminents
• Control strategies for manufacture, release and stability testing
• Irradiation of cannabis flowers
• CMC considerations for products to be used in clinical trials
• Recent developments and outlook to the future

Duration of the recording: approx. 120 minutes each part | in total approx. 4 hours
Lecture language: English | Slides: English

Your speaker: Prof. Dr. Markus Veit is the managing director of ALPHATOPICS GmbH. He studied pharmacy in Frankfurt, obtained his doctorate at the Julius-Maximilians-University in Würzburg and was assistant professor there in the Department of Pharmaceutical Biology. He is a member of the German pharmacopeial expert committee at BfArM. In the past 25 years, he has worked as a managing director in companies providing services for the pharmaceutical industry with a focus on pharmaceutical development, testing and regulatory affairs. At the same time, he designed and led numerous training and continuing education events for employees in the pharmaceutical and medical device industry. He is an expert for herbal medicinal products and was involved in numerous applications for marketing authorisations of herbal medicines in Europe and rest of the world. In the past years he is increasingly involved in projects related to medicinal and other cannabis products.

Webinars allow you to participate in training courses and lectures conveniently from anywhere at any time. They are the perfect way to keep up to date with the latest knowledge without much effort. You are also welcome to ask the speaker questions after the webinar.

Prices & conditions of participation

 € 710.00 per person plus VAT for both webinars
 € 395.00 per person plus VAT for booking of only one part

The fee includes for a single person booking:

• the one-time viewing of the booked webinar/ or webinar series by the person or persons named to us in advance.
• the receipt of the slides shown as a printable PDF file.

The training is personal and, in the case of an individual booking, is for personal training purposes only - not for an entire team.

If the training is of interest to a group of colleagues, please contact us. We will offer an attractive special group price, even for large groups.

Note on quota call-off: When booking the entire webinar series, two units per participant will be deducted.

For team training, please contact us.