Good Clinical Practice (GCP) is the international ethical, scientific, and practical standard to which all clinical research in humans is conducted. It is important that everyone involved in research is trained or appropriately experienced to perform the specific tasks that they are being asked to undertake.
This interactive and engaging course will provide you with an overview of the ICH GCP regulations and guidance and explore the 8 sections of GCP in one session. It will also include updates surrounding R3. Upon completion of this course, you will have a clear understanding of the importance of GCP and GDPR in clinical trials, the clinical drug testing process, risk management and the considerations in identifying critical to quality factors and quality by design.
This course can be booked on an individual or group basis. If you are interested in training for you or your organisation, please contact training@towermains.com.
✔ Importance of regulations in clinical trials
✔ The Declaration of Helsinki
✔ The history and development of clinical trials
✔ Understanding the clinical drug testing process and who is involved
✔ Risk-based approach to Monitoring
✔ Corrective and Preventative Actions
✔ The relationship between GDPR and clinical trials
✔ Considerations in identifying critical to quality factors
This course would be beneficial for individuals who are:
✔ New to GCP or would benefit from a refresher course
✔ Sponsors of clinical research who need to understand and update their GCP requirements
✔ Team members who lead and deliver clinical research
1 day
The course is delivered to groups of up to 20 learners and broken down into four modules:
Topic 1:
- Clinical research
- What is it?
- Why do we do it?
- How is it controlled?
- The regulations for UK clinical trials
- The Declaration of Helsinki
- The history of clinical trials
- The clinical drug testing process
- Who’s involved?
Topic 2:
- Introduction to the newly revised ICH GCP (R3) and ICH E8 (R1) and how they work together
- The 8 sections of ICH GCP
Topic 3:
- GDPR and Clinical trials
- Hot topics from inspection findings
Topic 4:
- Risk management and clinical trials
- Considerations in identifying Critical to Quality Factors and Quality by Design
This course consists of a mixture of presentations, and individual and interactive group exercises.
An electronic certificate of attendance will be issued to each delegate.
If you are interested in booking a future course, please contact Erin Bell to register your interest.
Testimonials
“I thought the course was informative and delivered by Fiona, someone who has first-hand experience of running/being involved in clinical trials. Her stories really brought the training material ‘to life’ and she answered all questions knowledgeably and honestly.”
“Easy to follow, very clear explained, entertaining, which is very helpful because the subject is sometimes heavy to digest.”
“I enjoyed the course immensely, the anecdotes made us laugh and helped make the content memorable. The experience and expertise of the presenters were clear and they promoted a friendly, open discussion where everyone was able to ask questions.”
“Fiona was very knowledgeable and engaging. They made the training informative and fun.”
“Extremely knowledgeable”
