These courses are suitable for laboratory and clinical researchers who need to understand their legal responsibilities in non-clinical and clinical trials environments. These courses are designed to support Sponsors, Investigators, Scientists, Medical Professionals, Clinical Research Organisations (CROs), Ethics Committee members, Quality & Safety monitoring teams, and other drug development/clinical trial stakeholders in fulfilling their legal responsibilities for non-clinical and clinical trials including clinical trial participant safety monitoring/adverse event reporting.
Online compliance training courses are now available for laboratory scientists and clinical trial/research personnel involved with drug development & drug approval processes.
Non-Clinical and Clinical Trials Training Program Support
The online training courses for drug development, quality teams and clinical trial personnel include Good Laboratory Practice (GLP) non-clinical, Good Clinical Practice (GCP for clinical trials) and pre-and post-marketing pharmacovigilance (drug safety surveillance and adverse event reporting/SAE reporting including post-marketing surveillance to meet the latest regulations). There are also courses in GMP compliance, data integrity assurances, ATMPs and more!
Visit the online GMP training store for a variety of certificate courses for life science researchers and pharmaceutical manufacturing personnel.
Our life sciences/regulatory compliance eLearning courses cover non-clinical and clinical trials standards, GMP/pharmaceutical manufacturing, quality management systems (PQS & QMS), quality risk management (QRM), pharmacovigilance/adverse event reporting responsibilities, and more!
Completing these non-clinical and clinical trials training courses will help you, your research teams, quality managers and manufacturing personnel to better understand their responsibilities for regulatory compliance.
In addition to GLP (non-clinical) training and GCP (ICH E6, E8) clinical trials personnel training, there is a special course covering regulations and licencing considerations for Medicinal Cannabis Clinical Trials/medical cannabis research).
The course is, however, suitable for all herbal medicine clinical trials. as it provides a robust overview of pharmaceutical testing, quality monitoring, safety reporting and drug approval processes for plant-based medicines.
In brief, the Medicinal Cannabis Clinical Trials course:
- Is suitable as an online training module for clinical trial researchers, medicine Sponsors and pharmaceutical research support teams (for various types of pharmaceutical products)
- Is specifically designed to help:
- Researchers working on investigations of new medicinal cannabis products (Medicinal Cannabis Clinical Trials or other herbal medicines)
- Assist Sponsors, Investigators and Clinical Trial personnel who are working through Ethic Committee/HREC applications and/or Regulatory Authority involvement to gain clinical trial approvals for medicinal cannabis (agencies such as the TGA, FDA, EMA, MHRA, etc).
- Research personnel who need a refresher course on GCP for various other medicines
- Sponsors unfamiliar with clinical trial requirements for controlled substances:
- Including Schedule 4 drugs/poisons
- Including Schedule 8 and Schedule 9 drugs/poisons
Who should take these courses:
- Sponsors of new medicines including medicines involving controlled substances
- Clinical Trial personnel
- Medical teams including Principle Investigators & Co-investigators
- Pharmacists involved with ATMPs/investigational drug products
- HREC/IRB personnel involved with drug approval processes
- Principal Investigators and Co-investigators
- Medicinal Cannabis Suppliers / Pharmaceutical Suppliers of unapproved drugs
- Laboratory scientists/medical researchers
- Data analysts/statisticians and report writers involved with data analysis for new medicines including plant-based medicines/cannabis trials
- Cannabis licence and permit applicants
Clinical Trials for Medicinal Cannabis: Suppliers
Suppliers of medicinal cannabis products* for clinical research purposes are also encouraged to complete the Medical Cannabis Clinical Trials course, along with the non-clinical and clinical trials courses (Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) training, along with the Pharmacovigilance regulatory compliance training course.
Clinical trials protocol approval processes – Regulations
Examples in the Good Clinical Practice/GCP compliance training course include an introduction to clinical trial applications to IRB/EC/HREC and regulatory authorities, clinical trial protocol design considerations (including participant inclusion and exclusion criteria), and clinical trial protocol approval. Course content also includes mandatory reporting processes for conducting clinical trials in Australia, the European Union, the UK, and the United States.
Our non-clinical and clinical trials training courses, including Good Laboratory Practice and GCP training, are suitable for individuals involved with clinical trial research for any type of investigational medicine or ATMP. Taken together, they provides an in-depth introduction to the processes involved in non-clinical investigations and clinical trials with human participants. GCP compliance training, for example, as well as the Cannabis Clinical Trials course, cover submitting clinical trial protocols to Ethics Committees, getting a clinical trial approved, when and where the regulatory agencies get involved (TGA, FDA, EMA, MHRA examples included), and the ICH efficacy guidelines for Good Clinical Practice (GCP) – ICH E6(R3) and general considerations for clinical trials.
If you have more than 10 individuals to train, contact us for a customised quote.
Recommended training for clinical trial personnel & CRO staff: Pharmacovigilance training course
Our online Pharmacovigilance/SAE reporting course covers ongoing drug safety monitoring, e.g. pre-marketing surveillance and post-marketing surveillance regulatory requirements. The module covers reporting requirements for adverse drug reactions (ADRs), unexpected adverse events including (SUSARs), and serious adverse events (SAEs).
- This course is an ideal refresher course and orientation training resource for research personnel who will be involved with GCP inspections (including the TGA Pharmacovigilance GCP inspection program).
- This course is beneficial for all regions and includes examples from key regulatory bodies in Australia (AUS), the United States (US), the European Union (EU), and the UK
Examples in the module include safety monitoring and SAEs reporting requirements (Pharmacovigilance guidelines and regulations) for Sponsors, Principal Investigators, and Doctors/Clinicians. Examples of Pharmacovigilance and serious adverse event reporting requirements and SAE reporting timelines are provided for key distribution regions including the United States (US) FDA, Australia (AUS) TGA, European Commission/European Union (EU) and EMA and the UK (MHRA).
Course Disclaimer:
- Courses are for education purposes only and are intended to supplement your onsite pharmaceutical training / regulatory compliance training programs.
- Course durations range from 1 to 2 hours to 4+ hours depending on the topic.
- Individual learning styles will impact completion timeframes.
- A signed/dated Certificate of Completion for your training records is provided upon successful completion of the training course/module (for forwarding to your Personnel Training Department/Quality Team and attaching to your CV when applying for research or quality management positions/operations roles or manufacturing roles.
Last updated on August 26th, 2025 at 02:19 pm
