The current coronavirus pandemic has created problems for the management of ongoing clinical trials. In response, regulators have produced guidance aimed at protecting the safety of subjects and clinical trial integrity. This webinar sets out how the US FDA and UK MHRA expect those involved in the management of clinical trials to address these problems.

Areas Covered in the Webinar:-

• Safeguarding patient safety
• Alternative approaches for products normally administered at the clinic
• Informed consent by quarantined patients
• Availability of clinical trial supplies
• Subject enrollment
• Handling protocol deviations
• Approval of protocol amendments
• Monitoring of trial participants
• Access to medical records
• Pausing clinical trials

Why Should You Attend:-

The COVID-19 pandemic has disrupted clinical trials in a number of ways, including site closures, travel restrictions, supply chain interruptions, and unavoidable protocol deviations or modifications.

The webinar will enable participants to adopt a risk-based, compliant response to the challenges posed by COVID-19 to the conduct of clinical trials.

Who Will Benefit:-

• Clinical investigators
• Clinical trial sponsors
• Manufacturers of clinical trial supplies
• Regulatory affairs professionals
• Clinics undertaking human trials
• Pharmaceutical manufacturers