O OPCM — Portuguese Medical Cannabis Observatory: Military Chemicals and Pharmaceuticals Laboratory (LMPQF) and Faculty of Pharmacy of the University of Lisbon (FFUL), today, September 20, 2019, welcome the first 25 students of the 1st Postgraduate Program in GxP, or GMP — Good Manufacturing Practices — for Medicinal Cannabis.
The training is the result of a joint initiative of these three entities, in partnership with the Association for the Development of Teaching and Research in Microbiology (ADEIM), thus inaugurating training in good practices applied to cannabis in Portugal.
The first two editions of the Postgraduate Course are already sold out and have students from all areas related to the production cycle of cannabis for medicinal purposes, from cultivation to extraction, through storage or distribution, among many others.
The course takes place on Fridays and Saturdays, in the auditorium of the Military Laboratory of Chemical and Pharmaceutical Products, on Avenida Dr. Alfredo Bensaúde, in Lisbon, from today until December 14, starting the second edition in January 2020.
The program is directed by Rui Loureiro, Guest Professor at FFUL, specialist in Industrial Pharmaceuticals and member of the Board European Health Futures Forum (EHFF), with current research focused on Health Quality Management and Health Risk Management systems.
Rui Loureiro explains that “Law 33/2018, of July 18, established the legal framework for the use of medicines, preparations and substances based on the cannabis plant for medicinal purposes. In this way, the entire production and development chain, from plant cultivation to its preparation and distribution, must be monitored and controlled to ensure that all products are produced in accordance with good practices and applicable requirements, such as GMP certification. This imperative thus creates new challenges for all those involved in the pharmaceutical circuit and the present postgraduate course aims to allow participants to update their practice, as well as project future developments in the cannabis sector in Portugal”.
The postgraduate course will have the following modules:
- Comparative regulations (national, community and extra community, Directive 2001/83/EC, Directive 2003/94/EC, …)
- GMP (Good Manufacturing Practices)
- GACP (Good Agricultural and Collection Practices)
- Applicable “GxP”
- National and International Logistics
- Security of Information and Physical Technologies
- Quality Function Management Systems
- Risk Management Systems
- Facilities, equipment, materials. human resources, processes and flows
- SOP construction management and control
- Specific challenges (microbiologicals, pesticides, “heavy metals”, safety, …)
- Audits
- Pharmacovigilance, cannabis and derivatives
- Development of drugs, preparations, cannabis-based substances
The collaboration protocols signed today between the OPCM, the LMPQF and the FFUL pursue the common objective of promoting the training of health professionals and the development of medical cannabis research in Portugal.