Continuing efforts to increase visibility into the clinical trial process have resulted in a number of proposed and final regulations, guidance documents, and principles for the sharing of both study-level and patient-level clinical data. In this webinar, industry leaders will review the current content and status of the different requirements and recommendations for data-sharing from the EMEA, FDA and PhRMA. This review will assist attendees in determining the necessary steps to navigate through the complicated field of data transparency and to assure compliance.
About the Author
Dr. Lindsay McNair has extensive experience in the pharmaceutical industry. Prior to joining WCG, she was a consultant to pharmaceutical and biotechnology companies, providing medical guidance on clinical development strategies and study designs for new drug studies, and medical oversight of all phases of clinical trials. Dr. McNair teaches graduate-level courses on the scientific design of clinical research studies. She has been actively involved in IRB work for 18 years, and has a Master’s of Science in Bioethics with a concentration in research ethics.Follow on Twitter More Content by Dr. Lindsay McNair, MD, MPH, MSB | Chief Medical Officer, WCG