Course overview
With regulatory inspectors increasingly finding GCP issues with monitoring clinical trials, it is becoming even more important for the biopharmaceutical industry, study sites, and CROs to employ efficient and accurate strategies for monitoring clinical trials. Also, the global COVID-19 pandemic has changed the ways clinical trials are monitored and resulted in remote and centralized monitoring techniques at the forefront of monitoring. This has created an environment that requires monitors to not only purely focus on site visits. Regulatory authorities promote these alternative ways of monitoring trial data and the future is likely to include a more hybrid monitoring approach.
This highly interactive course, which includes group discussions, ensures that monitors not only understand the importance of compliance with the latest GCP standards but also gain insights into how new monitoring approaches are shaping the future of clinical trials.
CPD Hours: 12
Course Content
- Day 1
- ICH GCP R3 Compliance considerations for monitoring clinical trials for the future
- Site selection
- Site initiation
- Monitoring visit procedures
- Day 2
- Study close-out visits
- Planning Patient recruitment strategies
- Oversight of monitoring
- GCP, documentation and archiving
- Reporting serious breaches and preventing fraud: what monitors need to know
- Preparing for audit and inspection visits to comply with GCP
Speakers
Laura Brown
Dr. Laura Brown is an independent pharmaceutical QA and training consultant. Laura is an expert in GCP compliance for running and monitoring clinical trials. She has more than 20 years of experience in the pharmaceutical industry in several senior roles and has worked for several companies, including GSK, Hoechst Marion Roussel, and Phoenix International in quality assurance of clinical trials.
Laura is an international expert on regulatory requirements in clinical research and was Chair of the Institute of Clinical Research GCP Forum for over six years. She writes regularly on clinical research regulatory requirements and is the author of several articles on the EU Clinical Trial Regulation, ‘The Planning of International Drug Development’ in the Clinical Research Manual, and has written a chapter in International Pharmaceutical Product Registration.
