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Pharmaceutical Regulatory Affairs in the EU and US

9 Module eBook

Online Learning

This 9-module self-study course has been specifically designed for new entrants to pharmaceutical regulatory affairs wanting a complete overview of the issues and systems affecting the approval of their products..

Work through the course at your own pace online, test your knowledge with end of module quizzes and receive a certificate once you've passed the final course quiz. This course is available for individual registrations or can be supplied to a department as a licence for a year.

  • Discover the origins and purposes of pharmaceutical regulation, and the principal regulatory bodies.
  • Know how to ensure your pre-clinical and clinical studies comply with both key EU and US regulations, including GLP, GCP, the EU Clinical Trials Directive and FDA requirements
  • Learn the fundamental procedures, issues and initiatives (including the FDA Critical Path) that will have an impact on your regulatory strategy
  • Gain awareness of other procedures so you can manage the approval process for a range of product types (including biosimilars, generics and variations)
  • Find the approach to gaining marketing authorisation that works for your markets – and make sure you meet the required safety standards.

This course is useful for anyone who works directly or indirectly  with regulatory affairs.

  • Regulatory Affairs Executives
  • Regulatory Affairs Managers

Our ebooks have been designed with great usability features to enhance your learning experience.

Don't just take our word for it, try our demo - email our marketing team today.

Nicholas Wells

Nicholas has been the managing director of Independent Pharma Consultants in the UK since 2005 and has been working in the field of regulatory affairs since 1998. He has extensive global regulatory experience gained through a successful career with companies including Abbott, Novartis and Pfizer, where he has held a number of senior positions. Clients turn to Nicholas for assistance not only in meeting regulatory requirements, but also in designing strategies for developing and marketing products in the EU and US. He holds a degree in Applied Biology and is a member of TOPRA.

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