Good Clinical Practice (GCP) Inspections Program
New online courses available for clinical trials and GCP compliance training. The latest online training courses at www.onlinegmptraining.com relate to drug safety through GCP (clinical trials) and pre-and post-marketing pharmacovigilance (drug safety surveillance and adverse event reporting/SAE reporting).
These courses cover pharmaceutical development quality management systems (QMS) and quality risk management (QRM), drug approval processes, regulations and guidelines.
Course content includes: investigational drug applications, the typical sequence of clinical trials and drug approval processes, clinical trial protocols, Sponsor/Principal Investigator role responsibilities, Good Clinical Practice (GCP) inspections, and Pharmacovigilance (drug safety).
The first newly released online training for Clinical Trials focuses on regulations and licencing considerations for conducting Medicinal Cannabis Clinical Trials. The course is, however, suitable for all herbal medicine clinical trials as provides a robust overview of pharmaceutical testing, quality monitoring, safety reporting and drug approval processes.
This intensive online Certificate training course for clinical trials includes a section on ICH GCP guidelines.
In brief, this 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 this Clinical Trials (GCP) course:
- Sponsors of new medicines involving controlled substances including cannabis
- Sponsors of other medicines who need to learn more about clinical trial requirements and drug approval processes
- Principal Investigators and Co-investigators
- Medicinal Cannabis Suppliers
- Laboratory researchers
- Data analysts/statisticians and report writers involved with data analysis for 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 course, along with the new online Pharmacovigilance training course.
Clinical trials and protocol approval processes – Regulation examples
Examples in this training course include an introduction to clinical trial applications to EC/HREC and regulatory authorities, clinical trial protocol design considerations (including inclusion and exclusion criteria), and clinical trial protocol approval and mandatory reporting processes for conducting clinical trials in Australia, the European Union, the UK, and the United States.
GCP for medicinal cannabis research studies
Course topic: Clinical trial requirements when investigating new medicines containing CBD and THC, with examples from Australia (TGA), the United States (FDA), Europe (EMA) and the UK (MHRA).
This extensive training module on Medicinal Cannabis Clinical Trials provides a robust introduction to clinical trial requirements for research involving new products containing cannabinoid (CBD) and Tetrahydrocannabinol (THC).
This course is also suitable for anyone who is new to clinical trial research for any type of investigational medicine, as it provides an in-depth introduction to the processes involved in submitting clinical trial protocals 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 guidelines for Good Clinical Practice (GCP).
Certificate training – Medicinal Cannabis research trials and GCP requirements
The online certificate training course also compares the TGA’s GCP guidelines (Australia-specific TGA clinical trial guidelines for the CTN/CTX Schemes) with the ICH CGP guidelines, because there are certain differences. Included in the module are the following topics:
- An overview of ICH-GCP principles and requirements
- Good Clinical Practice (GCP) considerations
- Ethics Committees and Clinical Trial Protocol submission requirements for medicinal cannabis medications
- Clinical trial approval processes for new drugs
- Reporting requirements and safety monitoring (pharmacovigilance)
- Human Research Ethics Committee membership requirements and clinical trial approval processes(HREC)
- IND and CTA applications for clinical trials involving medicinal cannabis
Note that pharmacovigilance is covered in Module 2 (which covers safety surveillance of pharmaceuticals more broadly, and is not medicinal cannabis-specific).
The online certificate training course for Clinical Trials involving cannabis also explores the Australian TGA GCP guidelines for clinical trials (e.g. for CTN vs CTX Schemes) compared with the ICH CGP guidelines, because there are certain differences.
Average course duration
This is an intensive orientation-course/training module. The Medicinal Clinical Clinical Trials course will take from 2 to 4 hours to complete, on average, but this can vary. You will gain access to the online course immediately upon purchasing the module online (check your emails, including your pre-filtered inbox folders).
How to gain access to your clinical trial course (resources)
- Medicinal Cannabis Clinical Trials and can be purchased at the online GMP training store (single-user licences).
- A certificate of completion is downloadable on the successful completion of a Final Assessment.
- If you have more than 10 individuals to train and/or need specific cannabis business cultivation training, contact us for a customised quote.
Course 2: Pharmacovigilance training course
This 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).
Course 2 in the newly released drug development and drug safety courses is the Pharmacovigilance module.
Pharmacovigilance, including regulatory compliance orientation training in relation to clinical trials (pre-and post-marketing pharmaceutical safety surveillance) and mandatory drug safety/adverse event reporting, is being released on September 14, 2020.
This online GMP/GCP training course relates to regulatory requirements for Pharmacovigilance during drug development AND after marketing authority is granted by the Regulatory Authority (i.e. the TGA, FDA, EMA, MHRA, or the specific regulatory authority in your region).
- This course is an ideal refresher course and orientation training resource for research personnel who will be involved with GCP inspections (including the TGA Pharmacovigilence 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 are provided for researchers, Sponsors and manufacturers in the United States (US), Australia (AUS), European Union (EU) and the UK (MHRA).
Average duration: online courses
Duration of this course
Allow from 1.5 to 3 hours for completion of the Pharmacovigilance course including your final assessment.
How to gain access to your Pharmacovigilance (certificate course)
- The Pharmacovigilance training module can be purchased at the online GMP training store (single-user licences)
- You can take the course in one sitting or over as many days as necessary
- You will have access to the course for 12 months
- A certificate of completion is downloadable on the successful completion of a Final Assessment
- One user/one learner per course purchase
If you have more than 10 individuals to train and/or need specific cannabis business cultivation training, contact us for a customised quote.
- Courses are for education purposes only and are intended to supplement your onsite pharmaceutical training / regulatory compliance training programs.
- Please also note that course completion time frames can vary from course to course and from person to person.
*Cultivators should complete these courses after Series 1 and Series 2 in the Medicinal Cannabis Cultivation training courses.