MHRA Guidance during the COVID-19 Emergency: Drug Regulation

Instructor: Mark Powell
Product ID: 706479
Training Level: Intermediate
  • Duration: 60 Min
In response to the global coronavirus pandemic, the UK’s MHRA has published guidance designed to protect the drug supply chain. The scope of the guidance is far-reaching (see below for details) and includes temporary changes to GMP and GDP expectations as well as some licensing arrangements.
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Read Frequently Asked Questions

Why Should You Attend:

The webinar will enable participants to comply with the MHRA’s expectations to protect the drug supply chain during the current COVID-19 pandemic.

The UK’s MHRA has relaxed certain regulatory expectations in order to assure the continued supply of medicines during the current COVID-19 emergency. These changes affect drug manufacture, distribution and arrangements for license variations. This webinar will detail these temporary arrangements, together with the controls necessary to maintain compliance.

Areas Covered in the Webinar:

  • Approval of GxP documents when working from home
  • Maintenance and calibration of equipment
  • Supplier qualification
  • Transportation of medicinal products
  • Regulatory inspections
  • Supply of pack-down products to retail pharmacies
  • Arrangements for imported products
  • Expedited assessment
  • Extended regulatory deadlines
  • Relaxed requirements for license variations

Who Will Benefit:

  • Drug product manufacturers
  • Drug product distributors
  • Drug product importers
  • Regulatory affairs professionals
  • Drug product license holders

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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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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