Management of risk is inherent to the conduct of pharmaceutical research including the conduct of clinical trials. During the current COVID-19 pandemic, regulatory and compliance risk is an acute concern by health authorities, pharmaceutical manufacturers, medical practitioners and patients. Navigating the expectations of global health authorities for conducting clinical studies and COVID-19 impact is challenging.
This webinar will discuss the challenges and potential mitigation strategies, in accordance with appropriate application of regulations and COVID-19 guidance documents, to ensure GCP compliance with respect to managing lost to follow-up and missing data:
- The impact of deviations from the protocol due to shelter-in-place orders and onset of COVID-19 symptoms.
- The increased risk of bias in the results of a trial and assessing the internal and external validity of study results.
- Ensuring that clinical trial data collected during the COVID-19 pandemic remains in compliance with Health Authority guidance.
- Continuity of clinical trial oversight by Sponsors and Health Authorities to maintain data integrity.
- Statistical approaches for evaluating the impact of COVID-19 pandemic.
Felicia has over 30 years of pharmaceutical industry expertise spanning Research & Development, Regulatory Affairs, Quality Assurance and Consulting including senior roles in Quality Assurance at several top, global pharmaceutical companies. At Parexel she provides Strategic Leadership to a team of former FDA Investigators delivering GxP compliance solutions and is also a member of Parexel’s Regulatory Consulting Service (RCS) Leadership Team, Compliance Leadership Team and COVID-19 Project Continuity Regulatory Sub-Team.
Felicia Ford-Rice, RAC
Director, Strategic Compliance
Peter is a biostatistician who works primarily with smaller biotech clients on the implementation of novel study designs, improved statistical analysis methods and efficient communication of results. He has over 20 year’s experience in clinical development of biologics and drugs and interactions with the global health authorities including the FDA and EMA.
Senior Director, Biostatistics