Dr Ingrid Walther
Pharma Consulting Walther, Chair of the ECA Cannabis Working Group
Referent:innen
Dr Rainer Gnibl
GMP Inspector
Luis Meirinhos-Soares
Former GMP Inspector at INFARMED, ECA Cannabis Working Group
Dr Georgia Tossi
Linnea, ECA Cannabis Working Group
Tina Cacanoska
PharmaRolly, ECA Cannabis Working Group
Dr Viviana Braude
Cronos Israel, ECA Cannabis Working Group
Dr Anne Wolf
German Cannabis Agency, BfArM (invited)
Dr David Surjo
GOC NEXUS
Joaquin Dell’Acqua
Agronomist
Note: All times mentioned are CEST.
Zielsetzung
Medical cannabis has been meanwhile permitted for prescription in several countries around the world, causing a need for producers supplying pharmacists and physicians with the newly legalized drug. But what qualifies as medical grade cannabis? And which aspects have to be considered for CBD-Products? This conference will give you an overview of all relevant GACP/GMP requirements and regulatory aspects for medical cannabis and CBD-Products.
Hintergrund
Medical cannabis products must comply with the relevant requirements laid down under Medicinal and Narcotics Law. The relevant requirements based on the underlying legal framework (including Pharmacopoeias) and the corresponding EU GMP/ GDP and GACP guidelines must be complied with when supplying medical cannabis to the EU market.
The EU GMP inspectorates are responsible for issuing manufacturing and import licenses or “GMP Certificates”. Thus, they will perform inspections at the sites of manufacturers who apply for these certificates and licenses. Meanwhile, European pharmacopoeial (Ph. Eur.) monographs describing the quality requirements for cannabis flower (API or for direct prescription to patients) and for CBD have been established and implemented. However, questions still arise, because:
- There is currently no harmonized “EU GMP Cannabis Standard” or “Global GMP Cannabis Standard” available for medical cannabis (API / Herbal Medicinal Product).
- The Ph. Eur. Cannabis Flower and CBD monographs are currently not harmonized with the corresponding USP (draft) monographs.
- Regarding quality requirements for Cannabis Extracts (Herbal Drug Preparation) only national monographs exist so far.
Thus, national regulations, guidelines and pharmacopoeial monographs will have to be followed and applied in addition to EUGMP.
Zielgruppe
This Live Online Conference addresses specific GMP aspects to consider for Growers, Manufacturers, Start-Ups, Suppliers, Importers, Wholesalers, QPs and QA/QC personnel involved in Cannabis production and release. The topics provided are also of interest for GACP/GMP/GDP Inspectors responsible for issuing a "GMP certificate" or manufacturers/import license.
Date & Technical Requirements
Date of the Live Online Conference
Tuesday, 19 May 2026, 12.00 to approx. 18.00 h
Wednesday, 20 May 2026, 10.00 to approx. 18.00 h
All times mentioned are CEST.
Tuesday, 19 May 2026, 12.00 to approx. 18.00 h
Wednesday, 20 May 2026, 10.00 to approx. 18.00 h
All times mentioned are CEST.
Technical Requirements
We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-trainingtechnical-information you will find all the information you need to participate in our events and you can check if your System meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Programm
Gesamtes Programm als PDF herunterladen
Programme – 19 May 2026
Introduction
- GMP for Cannabis: setting the scene
Discussion
GMP Certification / Challenges and Experiences from current Inspections
- Authorization, registration & import
- Which requirements apply?
- Current issues
The Intersection between GACP and GMP
- When does GACP end and (EU) GMP start?
- What will be checked during GACP and EU GMP inspections?
- Observations in inspections
- Open questions and issues to be solved
Cannabis Cultivation under GACP
- Cultivation and the implementation of GACP Standards
- Practical insights
- Case studies
Final Discussion Day 1
Programme – 20 May 2026
Microbiological Decontamination of Medical Cannabis
- Effects of decontamination on cannabis market activity
- Cannabis flowers and the microbiological challenges
- Landscape of decontamination technologies and limitations
Regulatory Status and Quality Standard of Cannabinoids Manufacture
- Pharma, food and cosmetic products and requirements
- How to differentiate between CBD/Cannabis Products for medical use and other CBD (Hemp) Products?
- Which legal rules apply?
- Practical examples
Drying of Medicinal Cannabis – Challenges for Process Validation
- Post-harvest processes as a preparation for drying of Medical Cannabis
- Drying process - different types of drying
- Sampling and testing during drying- what are the challenges?
- Validation of the drying process and determination of the end of drying
- Curing and why it is needed
- Testing after curing and storage of dry cannabis flowers
Discussion
Update from the German Cannabis Agency (Tbc)
- Current Status of Medical Cannabis in Germany
- Status of Cannabis Monographs (DAB / Ph. Eur.)
- Submission requirements for AMRadV applications
- Current Challenges
Discussion
Israel Medical Cannabis Regulation
- The Israeli Medical Cannabis unit and the licensing process
- Major guidelines: IMC-GAP, IMC-GMP, IMC-GDP, IMC-GSP
- Differences and similarities: Israel vs. Europe
- The export process to Europe
- The import process of medical cannabis to Israel
- Lessons learned from industry experience
Validation /Qualification - Experiences & Lessons learned
- Application of GMP principles to Cannabis:
- Quality management System (QMS)
- Facility Design
- Qualification / Validation: Points to consider
Final Discussion Day 2
| ECA-Member*: | € 1890,- |
| Non ECA Member*: | € 2090,- |
| EU/GMP Inspectorates*: | € 1045,- |
| APIC Member Discount*: | € 1990,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
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