The Drug Development Process from Concept to Market


Instructor: Mark Powell
Product ID: 706288
Training Level: Intermediate

  • Duration: 60 Min
The goal of pharmaceutical development is to design a manufacturing process that can produce a drug product to a consistently high quality. This webinar sets out regulatory expectations for pharmaceutical development, taking account of the risk-based approach set out in ICH guidance documents (Q8, Q9, Q10 and draft Q12). It covers some examples of problems encountered during drug development.
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Why Should You Attend:

Pharmaceutical development is a costly and time-consuming process. A science-led, risk-based approach can save time and money.

Successful pharmaceutical development requires effective collaboration between formulation scientists, analytical chemists and, during late-stage development, production staff at the commercial manufacturing site. This webinar focuses on regulatory expectations, techniques for managing risk and the importance of reliable analytical data to support the development process. It emphasizes the importance of effective collaboration between teams and the importance of setting product performance goals at the start. You will gain an improved understanding of the drug development process, the importance of knowledge management throughout the project, and how to evaluate and mitigate risks.

Areas Covered in the Webinar:

  • Regulatory expectations for pharmaceutical development
  • An introduction to quality risk management (ICH Q9)
  • Quality management of development projects
  • Proposed lifecycle approach to pharmaceutical products (ICH Q12)
  • Overview of the development process
  • Setting product performance goals
  • Analytical methods to support product development
  • Examples and case studies

Who Will Benefit:

  • Project managers
  • Formulation development scientists
  • Process development staff
  • Analytical development chemists

Free Materials:

  • Links to free web-based resources
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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