FDA and MHRA Guidance during the COVID-19 Emergency: Conduct of Clinical Trials


Instructor: Mark Powell
Product ID: 706477
Training Level: Intermediate

  • Duration: 60 Min
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.
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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.

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

Who Will Benefit:

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

Free Materials:

  • Reference documents
  • Rule documents or guidance
  • Checklist
  • SOP template
  • Easy fill in forms
  • Articles
Instructor Profile:
Mark Powell

Mark Powell
Director, Mark Powell Scientific Limited

Dr Mark Powell a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as a senior analytical chemist. Mark was Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016. He has worked at a senior level in a number of companies with responsibility for method development and equipment qualification. In 2010 Mark was appointed Scientific Manager of a UK-based pharmaceutical CRO, with responsibility for guiding the direction of drug development programs as well as establishing collaborations with academia and instrument manufacturers. His work resulted in a number of published papers and presentations at international scientific conferences. In 2013, he set up his own company to provide training and consultancy services to pharmaceutical professionals. His consultancy work has involved, amongst other things, managing the analytical aspects of pharmaceutical development programs and conducting data integrity audits. He is in demand as a trainer in topics such as chromatography, spectroscopy, pharmaceutical dissolution testing, data integrity, control of impurities, technical writing, stability/stress studies and sample preparation.

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