www.gmp-conference.org

GMP for Cannabis - What you need to know

Pre-Conference to the European GMP Conference

PROGRAMME

Welcome and Introduction

  • GMP for Cannabis: setting the scene

 Dr Ingrid Walther, Consultant

 

Production of Cannabis flos for medical purpose

  • Good Agricultural and Collection Practice, GACP
  • Cannabis Production / Infrastructure / Monitoring
  • Security Measures

Mag. Bernhard Föger, AGES

 

GMP Certification / Manufacturing and Importation Authorization

  • Aspects to consider for applications for Manufacturing and Importation Authorizations
  • GMP certification: What you need to know
  • Inspections in Europe and beyond: Typical and recurrent compliance issues

Dr Reinhard Kerker, GMP Inspector

 

Narcotic drugs – The regulations

  • Short overview of the German Narcotics Law ("Betäubungsmittelgesetz", BtMG)
  • Necessary documents for granting general licenses and import / export authorizations by the Federal Opium Agency (BfArM)
  • Reasons for refusal

Dirk Ohlenforst

 

Launch of Cannabis products

  • Requirements to fulfil
  • Infrastructure, global marketing and distribution agreements
  • Medicinal cannabis products like oils and oil derivate products such as capsules, sublingual wafers and topical creams

Savvas Koulouridas, Fagron

 

GDP for Cannabis

  • Requirements for transport to pharmacies, veterinary dispensaries, hospitals
  • Requirements for distribution of cannabis through international distribution partners, wholesalers and 3PL partners

Silja du Mont, GDP/GCP Inspector

 

Supplier qualification and handling after import

  • Facilities
  • Packaging
  • Release

Savvas Koulouridas, Fagron

 

Experiences - Lessons learned

  • Application of GMP principles to Cannabis
  • Quality management System (QMS) including Qualification/Validation
  • DAB Monograph “Cannabis Flos”: Points to consider

Dr Ingrid Walther, Consultant