EMA Guidance during the COVID-19: Requirements for Accelerated Assessment

Instructor: Mark Powell
Product ID: 706487
Training Level: Intermediate
  • Duration: 60 Min
Accelerated assessment of medicines in the EMA’s centralised procedure may be granted for treatments that are of major interest to public health. It is one of a number of regulatory mechanisms designed to provide early access to new drug treatments.
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Why Should You Attend:

Reducing the time taken to make a new therapy available to patients has obvious commercial and public health advantages. This webinar sets out the circumstances in which accelerated assessment may be offered by the EMA, and the steps required to secure such approval. It also covers two other regulatory mechanisms for early patient access: conditional marketing authorization and compassionate use.

The EMA’s centralized procedure for accelerated assessment is available to drug development companies that can demonstrate that the new treatment represents a major public health advance, especially for treatments that address an unmet clinical need. The accelerated assessment mechanism is closely related to the Agency’s scheme to support priority medicines (PRIME). Both topics will be discussed during this webinar, along with other regulatory mechanisms for early patient access to new medicines. This subject is especially timely in the context of the current global COVID-19 pandemic.

Areas Covered in the Webinar:

  • Legal basis
  • Criteria for accelerated assessment
  • Accelerated assessment timetable
  • Pre-submission meetings
  • Pre-approval inspections
  • Priority medicine support scheme (PRIME)
  • Conditional marketing authorisation
  • Compassionate use

Who Will Benefit:

Professionals developing new drug products for unmet medical need, including:

  • Regulatory affairs
  • Clinicians
  • Medical researchers

From

  • Pharmaceutical development
  • Clinical development

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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