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.

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