Medical Cannabis – Cultivation, Processing, Systems & Technology

Objectives

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/GDP requirements and regulatory aspects for medical cannabis and CBD-Products.

Registration

Register as a congress delegate for just 690 EUR/day!
This special offer is only valid until 31 December 2024!

Background

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 EU-GMP.

Target Audience

This conference addresses specific GMP and technical 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.

Moderators

Dr Ingrid Walther, Leader of the ECA Cannabis Working Group
Dr Andrea Kühn-Hebecker, ECA Cannabis Working Group

Tuesday, 8 April 2025
09.00 - 17.30 h

Challenges and Experiences from current GMP Inspections
Dr Rainer Gnibl, District Government of Upper Bavaria

• Authorization, Registration & Import
• Which requirements apply?
• Current Issues
  
  

The Intersection between GACP and GMP - View on the Inspection of Cannabis GACP and its Relation to GMP
Luis Meirinhos Soares, Bring Knowledge

• 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
  
  

Case Study 1 - Cannabis Cultivation under GACP
Natalie Thurner, Chemgineering
Dr Michał Wójcicki, Cannerald

• From GACP to GMP: Challenges, Learnings, Strategy, Inspection
• GACP confirmation for Cultivation / Harvesting
• Implementation of a GMP QA-System
• Regulatory hurdles in different global markets
• Export from Switzerland
  
  

Drying of Medical Cannabis – Challenges for Process Validation
Tina Cacanoska, PharmaRolly

• 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
  
  

 

Validation /Qualification – Experiences & Lessons learned
Dr Ingrid Walther, Pharma Consultung Walther

• Application of GMP principles to Cannabis
• Quality management System (QMS)
• Facility Design
• Qualification / Validation: Points to consider

Wednesday, 9 April 2025
09.00 - 18.00 h

Regulatory Status and Quality Standards of Cannabinoids Manufacture
Dr Giorgia Tossi, Linnea

• 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
  
  

Challenges in Microbiological Decontamination of Medical Cannabis
Dr David Surjo, GOC NEXUS

• Effects of decontamination on cannabis market activity
• Cannabis flowers and the microbiological challenges
• Landscape of decontamination technologies and limitations
  
  

Contamination Control Strategy in Cannabis Manufacturing
Martina Gjorgjevska, The FORCE CT
Apostol Todorovski, Sinceritas

• Implementing effective contamination control strategies specific to cannabis production environments
• Identifying common sources of contamination and how to mitigate them through process design and validation
• Regulatory requirements for contamination control in cannabis manufacturing (GMP, GACP, GDP)
• Best practices for maintaining cleanroom standards, equipment sterilization, and personnel hygiene to prevent contamination risks
  
  

Case Study 2 – Pharmaceutical Cannabinoid Extractions: Balancing Efficiency and Quality
Dr Nikos Xynos, Nomad Labs Scientific

• Processes and methods definition: The roles of literature, R&D, technology transfer and industry insights
• Different extraction, refining and purification technologies for cannabinoids recovery
• Key considerations for GMP compliance in integrated processes and technologies
• Environmental impact, cost efficiency, and operational aspects
• Intrinsic and extrinsic elements in pharmaceutical cannabis: Standardization, metrics, innovation, and expertise
  
  

Digitalisation in Cannabis Production
Hannes Schubert, Ness Online

• The 420+ Service Platform
• Automated compliance tools
• Smart Facility - Real-world applications
• The future of digitalisation in cannabis production
  
  

Israel Medical Cannabis Regulation
Dr Viviana Braude, Cronos

• 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
  
  

Medical Cannabis Manufacturing & Compounding: Regulatory Issues to be aware of Upfront
Dr Hanneke Later-Nijland, Genome Lawyers
Dr Monika Hupfauf, KOCH / HUPFAUF Attorneys-at-Law

• Legal hurdles with cultivation, import/ export, manufacture (or compounding) and distribution
• How could you benefit from compounding?
• Develop a regulatory strategy upfront: Narcotic law exemption and API-registration
• Groundbreaking regulatory news from the Netherlands and Austria