Live Online Conference: "GMP for Cannabis – what you need to know" and "Regulatory-Post-Conference"

Live Online Conference: "GMP for Cannabis – what you need to know" and "Regulatory-Post-Conference"

Course No 18707

Note: All times mentioned are CEST.

Costs

ECA-Member: EUR 2190,--
Non ECA Member: EUR 2390,--
EU/GMP Inspectorates: EUR 1340,--
APIC Member Discount: EUR 2290,--

(All prices excl. VAT)

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Claudia Baumung, CVUA Karlsruhe, Germany Moran Dvora, Gsap, Israel, ECA Cannabis Working Group
Oliver el-Atma, CVUA Karlsruhe, Germany
Michelle Johnson, Leafcann, Australia, ECA Cannabis Working Group
Dr Andrea Kühn-Hebecker, Concept Heidelberg, Germany, ECA Cannabis Working Group
Univ-Doz. Dr Reinhard Länger, Austrian Agency for Health and Food Safety (AGES)
Dr Ana Paula Martins, Assessor, Infarmed, Portugal
Silja du Mont, GDP/GCP Inspectorate, Germany
Angela Müller, Dr. Willmar Schwabe, Germany
Roland Pietz, GMP Inspector, Cologne, Germany
Luis Meirinhos Soares, GMP / GACP Inspector, Infarmed, Portugal, ECA Cannabis Working Group
Dr Constantin von der Groeben, DEMECAN, Germany
Silvia von Pistor, Tilray, Germany
Dr Ingrid Walther, Pharma Consulting Walther, Germany, Leader of the ECA Cannabis Working Group

Objectives

Medical cannabis has been permitted for prescription in Germany since 2017, causing a need for producers supplying pharmacists and physicians with the newly legalized drug. In addition, more and more countries around the world are following Germany by introducing programs in order to legalize cannabis for medical use. 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 regulatory and GACP/GMP/GDP requirements and aspects for medical cannabis and CBD-Products.

Background

In March 2017, the national German legislature expanded the options for prescribing medical cannabis products by passing a law amending provisions under the Narcotics Law and other regulations. These products, however, must comply with the relevant requirements laid down under Medicinal and Narcotics Law, including GACP/ GMP and GDP. Therefore, the BfArM (the Federal Institute for Drugs and Medical Devices) has taken over new responsibilities by establishing the Cannabis Agency. This agency is meant to help in ensuring supplies for medical-quality cannabis.

Unlike AGES in Austria, though, where cultivation of medical cannabis has already been established, cannabis will not be cultivated by BfArM itself, but by commissioned companies. Cannabis is not meant to be stored directly at BfArM during any stage of the purchasing, harvesting or distribution process. These steps will be carried out by relevant producers or other commissioned companies (i.e. suppliers, importers). Hence, the agency will manage and monitor the cultivation, harvest, processing, quality assurance, storage, packaging and distribution of cannabis to wholesalers, chemists or manufacturers.

The 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.
 
In summary:
  • The Cannabis Agency is responsible for ensuring that only medical grade cannabis is supplied,
  • The relevant requirements based on the underlying legal framework (including Pharmacopoeias) and the corresponding GMP, GDP and GACP guidelines must be complied with, and finally
  • Cannabis for medical purposes is also subject to the provisions of the Narcotics Law

Non-EU suppliers, who currently produce according to GPP, will have to implement EU-GMP standards if they want to supply medical cannabis to the EU market. However, since there is currently no harmonized EU standard and pharmacopoeial monograph (Ph. Eur.) for medical cannabis and extracts, national legislations, guidelines and pharmacopoeial monographs will have to be followed and applied in addition to EU-GMP.

Target Group

This Live Online Conference addresses specific GMP aspects to consider for Growers, Manufacturers, Start-Ups, Suppliers, Importers, 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. The regulatory Postconference is in particular interesting for RA personnel dealing with Marketing Authorizations.

Technical Requirements

For our Live Online Training Courses and Webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At https://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programme

Note: Provisional timetable, the actual schedule may vary depending on the situation.
 
 
GMP for Cannabis - what you need to know (14-15 June 2021)
 
Programme – 14 June 2021

13.00 – 13.15 h Welcome

13.15 – 13.45 h
Introduction
  • GMP for Cannabis: setting the scene
13.45 – 14.00 h
Time for Discussion
 
14.00 – 14.15 h Break
 
14.15 – 15.15 h
Requirements for EU GMP Certifications / Manufacturing and Importation Authorization (MIA) in Germany
  • GMP Requirements: What you need to know (EU GMP Guideline Part I)
  • Aspects to consider for applications for Manufacturing and Importation Authorizations in Germany
  • Aspects to consider for analytical labs
  • (Remote) Inspections in Europe and beyond: Typical and recurrent compliance issues
15.15 – 15.45 h
GDP for Cannabis
  • Requirements for transport to pharmacies, veterinary dispensaries, hospitals
  • Requirements for distribution of cannabis through international distribution partners, wholesalers and 3PL partners
15.45 – 16.15 h
Time for additional Questions and Discussion

16.15 – 16.30 h Break
 
16.30 – 17.30 h
Aspects to Consider for CBD (and other Hemp) Products
  • Requirements due to the German Narcotics Law
  • How to differentiate between CBD/Cannabis Products for medical use and other CBD (Hemp) Products?
  • Which legal rules apply?
  • Practical examples
17.30 – 18.00 h
Final Discussion Day 1
 
 
Programme – 15 June 2021
 
10.30 – 11.30 h
Australian GMP Requirements for Medicinal Cannabis and the Export of Product to Europe
  • Australian Regulations and the Therapeutic Goods Administration
  • Disparity between Eudralex 4, PIC/s PE009-14 and country specific requirements for MC
  • Bridging the gap for export to Europe
11.30 – 12.15 h
The Intersection between GACP and GMP - View on the Inspection of Cannabis GACP and its Relation to 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
12.15 – 12.45 h
Time for additional Questions and Discussion

12.45 – 13.45 h Break

13.45 – 14.45 h
Overview of Pharmacopoeial Monographs (and other Quality Requirements)
  • Europe (Ph. Eur.)
  • Germany (DAB / DAC)
  • Denmark
  • Netherlands
  • France
  • Switzerland (Ph. Helv.)
  • Israel
  • New Zealand (Product Quality Standards Monograph)
  • USA (USP)
14.45 – 15.00 h Time for additional Questions and Discussion

15.00 – 15.15 h Break

15.15 – 16.15 h
Israel Medical Cannabis Regulation & Export to Europe
  • 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
16.15 – 17.15 h
Experiences – Lessons learned
  • Application of GMP principles to Cannabis:
    • Quality management System (QMS)
    • Facility Design
    • Qualification / Validation: Points to consider
17.15 – 18.00 h
Final Discussion Day 2
 
 
Regulatory-Post-Conference (16 June 2021)
 
13.00 – 13.15 h Welcome and Introduction

13.15 – 14.00 h
Quality Requirements for Applications for Marketing Authorization
  • Borderline GACP-GMP
  • Types of extracts
  • Control strategy for extracts and drug products
  • Context with clinical data and regulatory pathway
14.00 – 14.15 h
Time for Discussion
 
14.15 – 14.30 h Break
 
14.30 – 15.15 h
GACP – Regulatory Information
  • Herbal Drugs
  • Framework
  • GACP vs. GMP
    • Guidelines
    • Interpretation
  • Information in the Dossier
    • Mockup
    • Grower and Supplier
    • Geographical source
    • Herbal substance Manufacturing
15.15 – 15.45 h
Regulatory Requirements for Marketing Authorization
  • Is a complete dossier always required?
  • Special procedures created by several MS, like Portugal & Denmark
 
15.45 – 16.00 h
Time for additional Questions and Discussion
 
16.00 – 16.15 h Break
 
16.15 – 16.45 h
Regulatory Submission in Portugal
  • Challenges
  • Practical aspects
  • Clinical indications
16.45 – 17.30 h
Regulatory Requirements for Cannabis Production in Germany
  • Interaction with the Cannabis Agency
  • Security Measures
  • Distribution to pharmacies
  • Production in Germany vs. Imports
17.30 – 18.00 h
Final Discussion

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