About This Course

International pharmaceutical legislation, regulations and guidance change at an alarming pace. These changes to legislation and guidelines, and their interpretation, can have significant implications for companies. Many changes require detailed planning to implement. Failure to do so can result in serious compliance issues.

We keep track of these changes, so you don’t have to. Part of a very successful series of continuing professional development (CPD) seminars, our one-day pharmaceutical legislation update course is ideal CPD for the busy QP or pharmaceutical quality professional who wishes to refresh their knowledge of pharmaceutical law and regulations.

This course is approved by the Royal Society of Chemistry approved as suitable for its members’ continuing professional development.

Key Learning Objectives

This course is designed to help you understand and discuss the current interpretation of recently implemented and proposed changes to:

  • EU legislation: Directives and regulations
  • EU GMP: Chapters and annexes
  • The impacts of Brexit on biopharmaceutical processes and supply chains across the EU and the UK
  • ICH guidance
  • U.S. legislation and FDA guidance
  • UK MHRA requirements and processes

Who Should Attend

  • Quality assurance personnel, Qualified Persons
  • Other technical/managerial personnel responsible for the manufacture and testing of APIs and medicinal products

Course Tutors

Course tutors will be selected from the following

Peter Gough - Peter has 50 years’ experience in the pharmaceutical industry and for the past 18 years has been responsible for advising senior management regarding changes to pharmaceutical legislation and guidance.

Giovanni Cosmi - Giovanni has 25 years of diversified experience in pharmaceutical quality operations management with several domestic and international companies. He has worked at operational and strategic levels within these for the review, maintenance and improvement of quality systems to ensure compliance on FDA and EMA current Good Manufacturing Practice (cGMP) expectations.