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

Mark Powell

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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.

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
Webinar Events
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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Mark Powell, Director, Mark Powell Scientific Limited

Dr Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as an analytical chemist. Mark was Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016, when his term of office ended. Between 2003 and 2013, he was the Analytical Development Manager, and later Scientific Manager, of a UK-based contract research organization which specialized in early-stage oral drug development. During this time, he was responsible for method validation, verification and transfer activities, as well as the qualification of laboratory instruments and computerized data systems. In 2013, he set up Mark Powell Scientific Limited, which provides training and consultancy services to pharmaceutical companies. Mark has since enjoyed working with companies of all sizes around the world on a variety of training and consultancy assignments, and has recently co-authored a White Paper on Pharmaceutical Data Integrity for the laboratory supply company VWR.

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