Points to Consider in the Development of Cannabis-based Medicinal Products – Pitfalls and Success Factors (6h content) (10512)

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 only one lecture, please follow the link below:
Course schedule

Part I
Duration: about 110 minutes

• Terms and definitions
• Applicable regulatory framework in Europe
• Demarcation between GACP – EU GMP Part II – EU GMP Part I
• Distinct quality requirements for herbal medicinal products in Europe
  • Herbal starting material (herbal substance)
  • Herbal preparation
  • Finished products
• CMC/GMP issues related to the manufacture of herbal preparations and herbal medicinal products
  • Pharmaceutical development
  • Process validation
  • Control strategy

Part II
Duration: about 100 minutes

• Different types of herbal preparations and specification concepts
  • Standardised extracts
  • Quantified extracts
  • Liquid preparations
• Development of combination products (dosing devices, vaporisers)
• Particulars of the IMPD | CTD for Herbal Medicinal Products
• Regulatory pathways in Europe
  • Full dossier | Full/mixed dossier
  • Well-established use
  • Magistral Preparations

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 of the recording: in total approx. 5 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

€ 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 entire webinar series, three parts per trained person will be deducted.

For team training, please contact us.