Development of cannabis-based herbal medicinal products in Europe - Cannabis Conference 2025

Conference for authorities, industry and science in English

In Europe, cannabis-based medicines are prescribed and dispensed as magistral formulations for patients or, in some member states, they can be prescribed for specific indications based on special licences. Sativex® is the only cannabis-based medicinal product with a regular marketing authorisation in Europe. This situation is certainly only temporary, and in the next few years further regularly authorised cannabis-based medicinal products will come onto the market. These products are ”herbal medicinal products”, for which there are a number of specific requirements in Europe.

The active constituents used as API in the preparations are present as multicomponent mixtures, mostly as extracts. This has implications for non-clinical and clinical development and specifically for CMC aspects. The focus here lies on ensuring batch-compliant traceability for the preparations to non-clinical and clinical batches, and a number of particularities arise that must be taken into account in non-clinical and clinical investigations.

Furthermore, there is always a risk of comparing ‘apples with oranges’ when referring to bibliographic data that may have been obtained with preparations that have different patterns of constituents than the preparation to be developed and authorised. This also applies to ”real world evidence” and ”real world data”. Finally, there are special considerations regarding the possibilities of data exclusivity and the establishment of IP protection. For products for nasal or inhaled administration, which can be useful for a rapid onset of action in acute situations, the particularities for combination products must be taken into account.

Success factors for the development of cannabis-based drugs:

Join the dialogue between authorities, industry and science!

We have addressed this topic and brought together experts from regulatory authorities and industry in various fields to provide a consolidated overview of requirements, hurdles and success factors in development projects with cannabis-based medicinal products.

With our event we also aim to engage with future applicants to contribute to the success of such projects.

Our conference creates a platform for the exchange of knowledge and experiences for the successful development of innovative, cannabis-based medicinal products in Europe.

Cannabis Conference 2025

From development to marketing authorisation

The following topics will be addressed:

Aspects of quality and securing the value chain (GMP, GACP)
Advantages and disadvantages of various preparations
‘State of the art’ in extract preparation
Particularities of the non-clinical development of active pharmaceutical ingredients as multi-component mixtures
Clinical development, necessary safety data, aspects of blinding
Options and possibilities for improving the biopharmaceutical properties of oral and oromucosal dosage forms
Particularities regarding the development of combination products (inhaled and nasal administration)
Framework conditions and success factors for clinical trial applications in Europe
Options for obtaining a marketing authorisation in the EU | Is ”well- established use” possible?
Use of ”real world data” and ”real world evidence”
Data exclusivity and patents

To the Programme

Cannabis Conference: Benefit from our speakers’ expert knowledge

Our speakers are all proven experts who will share their knowledge and practical experience with you from a great variety of perspectives.

Alphatopics Cannabis Conference 2025: The venue in Berlin

The hotel is located in a prime location on the world-famous Friedrichstraße, close to Berlin's most famous attractions and shopping opportunities. A place for first-class conferences and a relaxing stay – where business and comfort come together in perfect harmony.

NH Collection Berlin Mitte Friedrichstrasse
Friedrichstr. 96
10117 Berlin

NH Collection Berlin Mitte Friedrichstrasse | nh-hotels.de

Cannabis Symposium: Advice & Booking

Birte Doering and Daniela Müller will be happy to help you with your booking and are available to answer any further questions you may have.

Office hours Alphatopics:
Monday to Thursday from 8:00 a.m. to 1:00 p.m.

Phone: +49 8191 9737-130
E-mail: info(at)alphatopics.de
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