The Presentations at Cannabis Conference 2025: Get an overview!

• How to get started and who to ask?
• Pharmacopoeia monographs – why and when are they helpful?
• Cannabis preparations and THC/CBD – is there a difference?
• Which submission options exist?
• Application options: Full application, mixed applications, well-established use and/or any other options?
• Usage of "real world data" and "real world evidence" and non-interventional studies?

In the EU marketing authorisations can be obtained in individual member states, in a group of member states or in the entire EU and the countries of the European Economic Area. There are various ways in which bibliographic data can be used in such applications. Recently, the regulatory use of so-called "real world data" and the resulting "real world evidence" has also been discussed. The presentation will discuss the relevant aspects in this context as well as the framework conditions for the various authorisation routes.

• First EMA RWE Study on Cannabis flos 
• RWD sources already accepted by EMA  
• RWE/RWD to support regulatory decisions  
• RWE/RWD to support clinical development  
• Data quality considerations 

Today, the marketing authorisation of medicinal products is based on prospective clinical studies. The extent to which evidence can be established with data from real-world clinical practice (real-world evidence), which can be used supportively in the context of marketing authorisations or for the application for clinical trials in order to evaluate the safety and efficacy and thus the benefit-risk profile of a new medicinal product, is currently being discussed. Such an approach is particularly relevant for cannabis-based medicinal products, since many RWD on the use of cannabis and cannabis-based preparations are available in different indications. In this context, the origin of these data and their quality is of great importance. The presentation intends to highlight the possibilities and advantages, but also the limitations of RWD and RWE studies. For cannabis-based medicinal products these issues are of great importance for development projects. 

• The QTPP for cannabis-based medicinal products 
• Pharmaceutical development  
• Framework for non-clinical and clinical development 
• Decision gates, partners and contracts needed 
• Establishment and control of supply chain 
• Scientific advice from authorities 
• Investigational medicinal products

This presentation will give an introduction into a quality-by-design (QbD)-driven development approach which defines critical material attributes (CMA) and critical process parameters (CPP) resulting in an individual quality target product profile (QTPP) for a cannabis-based herbal medicinal product. Standard development activities for a pharmaceutical development project, starting with the characterisation and specification of the active pharmaceutical ingredient (API), its drug product formulation, manufacturing steps, through to the provision of clinical trial medication ("investigational medicinal product", IMP) as well as full analytical characterisation and testing will be described. From API supply through pharmaceutical development to the provision and release of IMP and clinical testing at a CRO various parties need to be responsibly involved as part of an integrated development roadmap. An overview of related integrated activities with decision gates and contractually defined responsibilities regarding quality and supply chain aspects will be given.

• Non-clinical safety data needed 
• Under which premises and to what extent can bibliographic non-clinical safety data be used? 
• Points to consider for justifying data on the mode of action of herbal extracts 
• Non-clinical pharmacology data needed 

Non-clinical development includes the establishment of pharmacological and toxicological data. A number of particularities arise from the fact that cannabis-based active ingredients used in herbal medicinal products represent multi-component mixtures. This not only requires comprehensive phytochemical characterisation but also has a number of implications for the design of experiments. Data collected in cell-free and cellular systems, i.e. not with intact tissue or not in the intact organism, are in many cases of limited value, since the bioavailability of the substances and mixtures investigated in the preparations is not known and biotransformation processes in the intact organism often result in metabolites that are then bioavailable instead of the genuine compounds. Conclusive data on the pharmacological mode of action can therefore not be established in many cases for herbal products. When evaluating safety data, it must always be shown whether the tested substances or preparations are representative of the medicinal product to be administered later.

• Lessons learned with CTAs: What has the industry achieved, and what are the pitfalls to avoid?
• HTA: Where and how? A strategic dive into the health technology assessment and its pivotal role
• Main challenges ahead: Insights into the hurdles shaping tomorrow's clinical development of cannabis-based medicines

As the clinical development landscape grows increasingly complex, adapting to emerging trends and regulatory frameworks is essential. The integration of real-world data and robust scientific evidence is becoming a cornerstone for supporting decision-making, but challenges persist in ensuring data quality and consistency. For cannabis-based medicines (CBMs), the regulatory pathway adds another layer of complexity, as it can vary significantly and has not yet been fully clarified. Similarly, health technology assessments (HTAs) are playing a more prominent role, requiring early alignment and strategic planning. By examining past lessons with CTAs and addressing the main challenges on the horizon, we can build more robust, efficient, and patient-oriented development pathways.

• Pros and cons for different types of herbal preparations to be developed as API (quantified vs. standardised) 
• Pros and cons for different types of extraction solvents
• Scalability of extract preparation 
• Value chain and GACP/GMP requirements 

Cannabis-based herbal medicinal products can generally contain standardised or quantified preparations as active ingredients. In development projects, the focus should be placed on quantified preparations, as these cannot be easily copied for the development of generics. In this context, a number of aspects need to be considered, resulting in pros and cons for both types of preparations. It must always be borne in mind that preparations made from cannabis are multi-component mixtures and therefore a comprehensive characterisation of such preparations is already required in the non-clinical development phases in order to ensure the traceability of the data. This is also of central importance if reference is to be made to bibliographic non-clinical or clinical data from third parties. In this context it is always necessary for applicants to be able to justify in a comprehensible manner why they consider data obtained with other preparations to be representative for a given development project. There are a number of other particularities that arise from the presence of multi-component mixtures in development projects. In this presentation, success factors and pitfalls will be presented in equal measure and advice will be given on how to avoid the latter. 

• General requirements for pharmaceutical development 
• How to improve biopharmaceutical characteristics of cannabis preparations in oral dosage forms  
• Case studies 

The oral bioavailability of cannabinoids from the initial cannabis preparations, such as extracts, is poor. This is generally also true for the oromucosal administration, as at least part of the administered dose can be swallowed and is therefore not absorbed in the oral cavity. In pharmaceutical development, there is now a spectrum of possibilities for improving the biopharmaceutical properties through appropriate formulations - this applies equally to liquid and solid oral dosage forms. In this presentation case studies will be used to illustrate how suitable formulation platforms can help to achieve oral cannabis-based products with an optimised bioavailability.

• Possibilities of inhalative administration 
• Pharmaceutical development with inhalative drug-device combination products
• Specific data and studies needed  

The inhalative administration of cannabis-based medicinal products is an important option when a rapid onset of action is desired in acute situations. There are a number of specifics that need to be considered when developing such orally inhalable products. These are well established for directly inhalable products in the EU. These include the particle or droplet size distribution of the dose, its aerodynamics and disposition, uniformity of dosage and a series of functionality tests of the medical devices used for administration as well as data on compatibility. Such (generally recognised) concepts do not exist for vaporisation as a route of administration and have yet to be developed. The presentation will provide an overview of the data to be established during pharmaceutical development and the areas of tension for administration by vaporisation.

• Types of DDCPs 
• Notified Body Opinion 
• Dossier requirements 
• Considerations for clinical development

Inhaled administration takes place via so-called integral combination products, in which the medical device is used to administer the medicinal product. The EU Medical Device Regulation (MDR) has resulted in a whole series of new or now clearly defined requirements. These products are regulated as medicinal products and are authorised accordingly. However, Art. 117 of the MDR stipulates that the authorisation application for an integral medicinal product/medical device combination must contain information and data for the medical device component and its assessment. This assessment ("Notified Body Opinion") is carried out by Notified Bodies. At the same time, there is a range of specific information to be implemented in the medicinal product dossier or the IMPD. The speakers will provide an overview of this complex of topics.

• Types of cannabis extracts 
• Purification of cannabis extracts 
• Terpenoids in cannabis extracts 
• How to archive batch-to-batch consistency 

Cannabis extracts are complex multi-component mixtures. If they are to be used as active ingredients in authorised herbal medicinal products, they must fulfil a number of distinct requirements. Of central importance here is batch-to-batch conformity, which must also be scalable in the course of development projects. Furthermore, it is sensible to preserve desirable ingredients during extraction from the genuine plant material and, if necessary, to enrich desirable and purge undesirable ones within the scope of the development of quantified and standardised extracts. This applies not only to cannabinoids, but also to terpenes and possibly flavonoids as well as other groups of constituents. This requires modern extraction techniques and detailed process knowledge. The presentation is intended to provide an insight into what is already possible today and where the challenges lie in the future.

• Regulatory data protection and market exclusivity in the European law 
• Possibilities and limitations of IP protection 
• Future development ("Pharma Package") 

Pharmaceutical innovations and the necessary investments for that purpose can be protected against imitation through patent protection and regulatory data protection, thus giving companies the opportunity to recoup their previous research and development costs. Both protection mechanisms work in parallel and are limited in time with different concepts. Patents must be applied for at a very early stage of development, and it is therefore necessary to already evaluate the various options for patents in the planning phase. In the case of herbal active ingredients, multiple possibilities in the value chain exist to prevent or at least impede the development of generics in the future. This is also something to be evaluated and established in development projects from the outset. In all cases, the aim is to prevent competition from products with the same or similar active ingredient for as long as possible.