Part III: Points to Consider in the Development of Cannabis-based Medicinal Products – Pitfalls and Success Factors (10515)

An increasing number of working groups are engaged in the development of cannabis-based medicines. In doing so, a number of special features relevant for development projects with herbal medicinal products are often not sufficiently taken into account. Such peculiarities already arise in early development phases and can, in the worst case, lead to projects failing in late development phases. This webinar aims to provide an overview of all aspects relevant in the context of such development projects. In particular, it is intended to provide the tools needed to deal with the special features that arise from the fact that herbal active ingredients are multi-component mixtures. At the same time, risks but also opportunities (e.g. with regard to IP protection) in such development projects are intended to be highlighted.

If you would like to book the whole series, please follow the link below:
Course schedule

Part III
Duration: about 95 minutes

• Non-clinical development
  • Specific considerations for non-clinical testing with herbal preparations
  • Specific considerations for toxicological testing of herbal preparations
  • Genotoxicity testing
• Framework for clinical development (of herbal medicinal products) in Europe
• Implications of the clinical trial regulation
• GMP requirements for investigational medicinal products
• Blinding issues for herbal medicinal products
• Considerations to ensure traceability between clinical and commercial batches
• Questions from participants

Duration: series in total approx. 5 hours
Lecture language: English | Slides: English

You cannot attend the live event? Then book the recording.

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

 € 795.00 per person plus VAT for the whole series
 € 295.00 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 webinar, one part per trained person will be deducted. For team training, please contact us. Cancellation is no longer possible after the access codes and/or slides have been sent.

Cancellation is no longer possible after the access codes and/or slides have been sent.