About the event
This Symposium is in partnership with the US Food and Drug Administration (FDA).
Regulatory agencies conduct Good Clinical Practice (GCP) inspections to assure the integrity of data generated in clinical trials and to confirm the protection of human research subjects, in addition to ensuring that clinical trials are conducted according to the applicable regulations. With the globalisation of clinical trials, regulators have increased collaboration amongst themselves to evaluate the adequacy of clinical trial conduct to optimise regulatory resources and oversight.
This event continues the discussion from the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) and the US Food and Drug Administration’s (FDA), Center for Drug Evaluation and Research (CDER) October 2018 GCP Symposium: Data Integrity in Global Clinical Trials - Are We There Yet? This event will provide regulatory perspectives on the importance of sponsor oversight of clinical sites and laboratories, eSource including electronic health records, protocol deviations including the impact on clinical trials, and the challenges in ensuring data quality in novel clinical trial designs. On day two workshop participants will have opportunities to work on relevant case studies on these topics.
At this symposium, participants will learn:
Key aspects regarding sponsor oversight of clinical investigator sites and laboratories
Impact of eSource on clinical data
Investigator control of their data
Impact of data quality on decision making
How handling of protocol deviations impact data reliability and subject safety
The challenges faced in ensuring data quality in novel clinical trial design
The joint MHRA and FDA GCP Symposium is part of a week-long series of events led by the MHRA Inspectorate. Interested in attending more than one symposium? Details of discounted combined tickets are listed in the registration section via the Register link above.