It’s really no secret that the evolving regulatory landscape for clinical trials is a hot topic amongst the community. Just take a look at the agenda for the 6thAnnual CROWN Congress, it’s jam-packed with sessions focused on the eagerly anticipated ICH E6 revisions, the new EU 536/2014 clinical trial regulations, risk management and centralized monitoring. Of course, with the increased pressures coming from the regulatory bodies, sponsors are racing to implement recommendations to ensure that their clinical trials run in line with guidance.
With that in mind, we’ve put together a list of the #CROWNClinical ’17 sessions that you absolutely can’t afford to miss:
Risk-Based Monitoring and the Centralized Monitoring Model – Mapping out and Executing a Centralized Monitoring Approach to Optimize Operational Quality and Efficiency
Speaker: Steve Young, Senior VP of US Operations, CluePoints
Date & Time: Wednesday, March 8, 2017, at 3:30pm
Changing Regulations – Evaluating the Changing Global Regulatory Environment and the Impact on Clinical Risk Management
Speaker: Doreen McGirl, North America Lead, Global Quality Business Operations, Otsuka
Date & Time: Thursday, March 9, 2017, at 08:30am
Proactive Risk Management – Proactively Planning for Risk Realization and Managing Response
Speaker: Stephen Potter, Director, Clinical Development Quality, Pfizer
Date & Time: Thursday, March 9, 2017, at 09:15am
Clinical Operational Shifts – Examining how Evolving Regulations, Quality Expectations and Risk Assessments are Driving Changes in Clinical Operations
Speaker: Federico A. Feldstein, J.D., Vice President, Global Head of Bio Research Quality and Compliance, The Janssen Pharmaceutical Companies of Johnson & Johnson
Date & Time: Thursday, March 9, 2017, at 1:00pm
Not registered yet? – use discount code ‘C846CLUEPOINTS’ to save 15% on registration.
If you would like to schedule some time to discuss the upcoming regulatory revisions, Risk-Based Monitoring implementation, or anything else, please send an email to [email protected]
See you there!