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Designing a Registration Stability Study from Scratch

View Webinar

Register now to view our recent webinar where Dr. Mark Powell discussed designing a registration stability study from scratch.

The aim of this webinar was to provide guidance on the design of long-term stability studies in support of a MAA or NDA.  As well as describing the general requirements for different dosage forms, differences in expectations between EU and US regulators were highlighted.  Depending on the dosage form and pack type, certain risks require mitigation prior to registration batch manufacture and stability set-down: these were also discussed.  Confidence in test methods and a plan for low-level impurity data reporting are also important elements.  Finally, study designs were discussed, including different product configurations and requirements for registration in Climatic Zones III and IV.

Topics covered included:

  • Regulatory expectations for different dosage forms
  • Product knowledge
  • Test method and data reporting considerations
  • Study design
  • Different strengths/primary pack configurations
  • Considerations for global registration

Guest speaker

Dr. Mark Powell, Director at MP Scientific

Dr. Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as a senior analytical chemist. Mark has served as both Honorary Secretary and 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 analytical 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 programmes as well as establishing collaborations with academia and instrument manufacturers. In 2013, he set up his own company to provide training and consultancy services to the pharmaceutical industry. His consultancy work has involved, amongst other things, managing the analytical aspects of pharmaceutical development programmes and conducting data integrity audits.

He is in demand as a trainer in topics such as chromatography, spectroscopy, dissolution testing, data integrity, control of impurities, technical writing, stability/stress studies, method validation, extractables and leachables, and root cause analysis.