Plant based medicines workshop – includes Medicinal Cannabis

Day 1: Regulatory Requirements

TOPIC: Regulations

  • United Nations Single Convention on Narcotic Drugs
  • Good Agricultural and Collection Practices (GACPs)
  • Good Manufacturing Practices (GMPs)

Introduction to regulations and compliance including medicinal cannabis.

As a controlled substance, cannabis falls under the UN Single Convention on Narcotic Drugs. This course will outline at a high level why countries need to enact specific legislation to control the production and distribution of narcotics, leading to the establishment of licensing and permitting schemes in most countries. This is especially true for goods of high illicit value (GHIV).

Plant based medicines, such as medicinal cannabis are pharmaceutical drugs that may be administered to critically ill patients. Therefore, they must be grown with care, adhering to strict standards throughout the cultivation process. The pre-harvest and harvesting processes must be performed in accordance with Good Agricultural Practices (GAP).

  • EU Good Agricultural Practice – GAP guidance
  • WHO Good Agricultural & Collection Practice – GACP guidance

Pharmaceutical dosage forms need to be manufactured in accordance with pharmaceutical legislation, regulation and Good Manufacturing Practices. This means an on-site Quality Management System (QMS) must be established and followed. At a high level, this covers hygiene, what constitues a batch, batch traceability, essential record keeping (Good Documentation Practices or GDocP), quality risk management and Corrective and Preventive Actions (CAPA).

There are EU, PIC/S, and US FDA GMPs; this course will mainly focus on EU and PIC/S GMPs. Currently, it is not possible to export cannabis to the USA.

  • Part 1 – Good Manufacturing Practice (final dosage forms) and
  • Part 2 – Good Manufacturing Practice (Active Pharmaceutical Ingredients)

If a substance (drug) is intended to prevent, cure, or alleviate the symptoms of an illness or medical condition, internationally agreed standards exist for gathering suitable clinical evidence and presenting the information to regulators for approval. The clinical evidence is presented in a Common Technical Document (CTD) format, which is harmonised across most jurisdictions.

Lastly, products must be labelled accurately and clearly, without exaggeration to ensure that patients adhere to strict dosage guidelines.

Day 2: Cultivation and Harvesting of Medicinal Products

TOPIC: Industry Overview, Cultivation and Harvesting

This course covers the more practical aspects of cultivating medicinal cannabis, common diversion risks and how to set up a facility for long-term success.

  • Introduction: market requirements and regulations
  • Security
  • Quality Control Standards
  • Botany and plant requirements
  • Stages of cannabis cultivation and production
  • Facility design and cultivation decisions
  • Lighting and power
  • Water and nutrients
  • Integrated pest management
  • Genetics, mother plants and cloning
  • Cultivation
  • Harvesting, trimming and drying
  • Cleanliness and safety
  • Cost drivers
  • Ecosystem

About this training

Our 2-day Plant Based Medicines course is ideal for government officials, industry business owners, including existing businesses and start-ups, cultivation and processing personnel, quality managers, and importers and exporters. It is suitable for anyone wanting to know more about the Herbal Medicinal Products sector, including insights into regulatory and cultivation requirements.

About us

PharmOut’s medicinal cannabis consultants are recognised as having extensive experience in the pharmaceutical manufacturing industry, including validation training, GMP (PIC/S, EU or US FDA) compliance training, medicinal cannabis cultivation and global medicinal cannabis industry knowledge and medicinal cannabis industry consulting expertise, including quality management systems (QMS), site selection, security, workflows and licencing applications.

Why take this course?

Regulatory Training Course

We understand that medicinal herbs and medicinal cannabis is a rapidly evolving field, and it can be challenging to keep up with the latest research and developments. Whether you are new to the field of medicinal cannabis cultivation or want to expand your industry knowledge, completing this Certificate Course will be of benefit.

What you’ll learn by attending this 2-day Plant Based Medicines Industry course

Regulations and compliance

We recognise the importance of staying abreast of the legal and regulatory framework governing medicinal cannabis. Our courses provide comprehensive coverage of the current laws and regulations in various jurisdictions, offering insights into regulatory compliance guidelines. This includes an overview of the global regulatory landscape, the impact of the United Nations Single Convention on Narcotic Drugs, 1961 as well as the requirements of Good Agricultural & Collection Practice (GACP) and Good Manufacturing Practice (GMP).

Importance of quality control and compliance

Learn the importance of quality control and compliance, including best practices for maintaining accurate records, testing and analysing cannabis products, and adhering to strict sanitation and safety protocols.

Who should attend this course

  • Individuals interested in learning more about cultivation
  • Business owners entering the medicinal cannabis industry
  • Horticulturalists, gardeners, plant disease experts interested in employment in plant medicine cultivation
  • Plant supervisors / Production Crop Managers
  • Regulatory Authorities and Industry Inspectors
  • · Government Authorities