Course Overview

  • “Course was extremely beneficial as it provided an insight in the ever-changing regulatory requirements and provides a heads-up of what to expect and what to do to ensure continued compliance.” Caitriona Lenagh / Almac Clinical Services, UK
  • “Pete is always extremely knowledgeable and his personality and the way he delivers the material makes the course great!” Marie Aherne / Novartis, UK
  • “Good concise summary of upcoming legislation.” Meriam Lindsay / Protherics, UK
  • “As always, a really valuable course to attend. Well-presented and excellent documentation.” Justin Barry / Midatech Biogune, Spain

International pharmaceutical laws, regulations and guidance change at a frightening pace – it’s difficult to keep up! That’s why we have developed this 1 day “refresher” course for you. We keep track of all the changes so you don’t have to – just come along and learn what’s new and what’s on the horizon. Ideal CPD for the busy Qualified Person or pharmaceutical quality professional.

About This Course

Pharmaceutical legislation and regulatory authority guidance is continually changing. These changes to legislation and guidelines, and the interpretation of them, can have significant implications for companies. Many changes require detailed planning to implement and failure to do so can result in serious compliance problems.

This is the continuation of a very successful series of one-day seminars that are designed to form part of your CPD. This course is also Royal Society of Chemistry approved as suitable for their members’ CPD.

Key Learning Objectives

To understand and discuss the current interpretation of recently implemented and proposed changes to:

  • EU legislation: Directives and regulations
  • EU GMP: Chapters and annexes
  • ICH guidance
  • US legislation and FDA guidance
  • UK MHRA requirements and processes including the potential impacts of Brexit on biopharmaceutical processes in the UK

Who Should Attend

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

Course Tutor

  • Peter Gough; Peter has over 40 years’ experience in the pharmaceutical industry and for the past 15 years has been responsible for advising senior management regarding changes to pharmaceutical legislation and guidance.

Other Dates and Venues for this Course

For other dates and venues for this course, visit our course calendar

Course Fees

Course cost (excluding VAT)  £790.00

Early bird and multiple delegate booking discounts available. Discounts also offered to NHS staff, regulators,
and charities – contact us for details

Have a question or want to book a place? Contact - you can also register online by clicking below.