With speakers from authorities (BfArM), industry and science

The Cannabis Conference 2025 was a great success – featuring exciting presentations, leading industry experts, and intensive professional exchange. We extend our thanks to all participants – especially our speakers for their committed contributions and inspiring insights.
The consistently positive feedback from attendees confirms that the event struck a chord within the industry.
As soon as new, relevant topics emerge, we will plan another event – because the dialogue continues. Stay informed! Use our non-binding reminder service to receive notifications as soon as the next conference is announced. This way, you can secure your spot early and benefit from the exclusive early-bird offer.
A Look Back: Cannabis Conference 2025
The Cannabis Conference 2025 provided intensive exchange, in-depth expertise, and numerous impulses for the industry. Discover the highlights, impressions, and key topics of the event.
Development of cannabis-based herbal medicinal products in Europe - Cannabis Conference 2025
Conference for authorities, industry and science in EnglishIn 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:
The dialogue between authorities, industry, and science was joined.
This topic was addressed, and experts from regulatory authorities and various industry fields were brought together to provide a consolidated overview of requirements, hurdles, and success factors in development projects with cannabis-based medicinal products.
With this event, future applicants were also engaged to contribute to the success of such projects.
A platform was created by the conference for the exchange of knowledge and experiences to support the successful development of innovative cannabis-based medicinal products in Europe.

Cannabis Conference 2025
From development to marketing authorisationThe focus was on the following topics:
- 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

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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