Dr Ingrid Walther
Freelance Consultant and GMP Expert, Chair of the ECA Cannabis Working Group
Referierende
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 Eva Kucerova
Czech Medical Herbs
Dr David Surjo
GOC NEXUS
Highlights
- GACP/GMP requirements for Medical Cannabis
- How to get a MA-, Import-License (MIA) / How to get a GMP Certificate
- Experiences from current Inspections
- Aspects to consider for CBD
- How to get GMP certified for Export
- Decontamination
- Qualification / Validation
- Lessons learned
- GACP/GMP requirements for Medical Cannabis
- How to get a MA-, Import-License (MIA) / How to get a GMP Certificate
- Experiences from current Inspections
- Aspects to consider for CBD
- How to get GMP certified for Export
- Decontamination
- Qualification / Validation
- Lessons learned
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.
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.
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 EUGMP.
Programm
Programme – 11 May 2027
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
Medical Cannabis Stability Studies- From Regulatory Requirements to Practical Application
- Introduction & regulatory Framework
- Stability principles & study design
- Cannabis flower
- Cannabis oil/extract
- Data evaluation & GMP ongoing stability
- Case studies / conclusion
Final Discussion Day 1
Programme – 12 May 2027
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
Challenges in the Release of Cannabis: A QP Perspective
- GACP vs. GMP vs. stakeholders - “conflict of interests”
- Identification of main issues for batch release in the supply chain and manufacturing
- As QPs: Can we handle it all successfully?
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
Weitere Informationen
Technical Requirements
Our live online training courses are conducted using Webex. At www.gmp-compliance.org/training/online-training-technical-information you will find all necessary information for participation, including a system check to verify whether your IT environment meets the technical requirements. If the installation of browser extensions is restricted due to internal IT policies, please contact your IT department. Webex is widely used, and installation is straightforward.
Fees (per delegate plus VAT)
ECA Members EUR 1,890
APIC Members EUR 1,990
Non-ECA Members EUR 2,090
EU GMP Inspectorates EUR 1,045
The fee is payable in advance after receipt of invoice.
Presentations/Certificate
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference language
The official conference language will be English.
You cannot attend the Live Event?
Many of the training courses and conferences are also available as recordings. You may watch these any time “on demand” on our web server. It is uncomplicated and doesn’t require any software – you simply watch the videos in your browser. All available recorded events can be found at www.gmp-compliance.org/recordings.
Contacts:
Questions regarding content:
Dr Andrea Kühn-Hebecker, +49 62 21 84 44-35, kuehn@concept-heidelberg.de
Questions regarding organisation:
Ms Isabell Helm, +49 6221 84 44-49, helm@concept-heidelberg.de
Our live online training courses are conducted using Webex. At www.gmp-compliance.org/training/online-training-technical-information you will find all necessary information for participation, including a system check to verify whether your IT environment meets the technical requirements. If the installation of browser extensions is restricted due to internal IT policies, please contact your IT department. Webex is widely used, and installation is straightforward.
Fees (per delegate plus VAT)
ECA Members EUR 1,890
APIC Members EUR 1,990
Non-ECA Members EUR 2,090
EU GMP Inspectorates EUR 1,045
The fee is payable in advance after receipt of invoice.
Presentations/Certificate
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference language
The official conference language will be English.
You cannot attend the Live Event?
Many of the training courses and conferences are also available as recordings. You may watch these any time “on demand” on our web server. It is uncomplicated and doesn’t require any software – you simply watch the videos in your browser. All available recorded events can be found at www.gmp-compliance.org/recordings.
Contacts:
Questions regarding content:
Dr Andrea Kühn-Hebecker, +49 62 21 84 44-35, kuehn@concept-heidelberg.de
Questions regarding organisation:
Ms Isabell Helm, +49 6221 84 44-49, helm@concept-heidelberg.de
Datum & Uhrzeiten
Tue, 11 May 2027, 12:00-18:00 h
Wed, 12 May 2027, 10:00-18:00 h
All times mentioned are CEST.
Wed, 12 May 2027, 10:00-18:00 h
All times mentioned are CEST.
Teilnahmegebühr
| 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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E-Mail: info@concept-heidelberg.de
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