Presented by
Management Forum
This course will assure monitors understand the importance of compliance with GCP standards, and how these apply to monitoring clinical trials including during the pandemic and in the future.
5-6 June 2023
+ 9-10 October 2023
from £1099
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. These alternative ways of monitoring trial data are promoted by regulatory authorities and the future is likely to include a more hybrid monitoring approach.
This course will assure monitors understand the importance of compliance with latest GCP standards, and how new monitoring approaches in clinical trials are being employed for the future.
Key Objectives:
Ensure GCP compliance for monitoring clinical trials including during Covid and monitoring approaches for the future
Evaluate the development of monitoring plans through protocol analysis for remote risk management
Discuss tools and risk evaluation approaches for remote monitoring
Ensure appropriate site selection, initiation, monitoring, and close out visits are carried out including during a pandemic.
Review sponsor and CRO oversight of monitors
This course will benefit those involved in the monitoring of clinical trials, including new and soon-to-be monitors. This will also be an ideal refresher including how monitoring has changed because of the pandemic and those responsible for oversight of monitors.
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.
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
Please contact us for pricing if you are interested in booking 5 or more delegates
5-6 June 2023
Live online
09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 12762
Not ready to book yet?
for 7 days, no obligation
9-10 October 2023
Live online
09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 12763
Until 04 Sep
Not ready to book yet?
for 7 days, no obligation
* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.
Austria
United Kingdom
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Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to: