On 28 October 2022 held a workshop on “Tips for successfully engaging with Human Research Ethics Committee”. This workshop was designed to provide a forum for participants from across the medicinal cannabis industry, and particularly medicinal cannabis companies and research organisations, to discuss approaches to successfully engaging with HREC in the area of clinical trials involving unregistered medicinal cannabis therapeutic goods.
MCIA is supporting this to assist in enabling and encouraging robust clinical research in the sector.
The workshop covers:
- Sponsor obligations and responsibilities
- Botanical drug product and quality control
- Preclinical evidence
- Trial design
- Dr Melinda Thompson, Head of Regulatory Affairs & Quality Systems Source Certain and Chair of MCIA Research Working Group
- Professor Andrew McLachlan, Head of School & Dean of Pharmacy, University of Sydney
- Biljana Georgievska, EVP Commercial, Nucleus Network
- Dr Anastasia Suraev, The Lambert Initiative
This MCIA Workshop was recorded on 28 October 2022