Course Overview

  • “Good balance between content and delivery.” Mahboob Rehman / Eaststone, UK
  • “As always, a really valuable course to attend. Well-presented and excellent documentation.” Justin Barry / Midatech Biogune, Spain
  • “At a time of unprecedented change and more to come, this was an excellent course to highlight these changes to help check that I hadn’t missed anything and what this means to the industry. I am not alone!” Carol Sandercock / Helena Biosciences Europe, UK
  • “Very beneficial to discuss impact with other delegates and gain an understanding of their challenges as well as our own.” Caitriona Lenagh / Almac Clinical Services, UK
  • “Good concise summary of upcoming legislation.” Meriam Lindsay / Protherics, UK
  • “Yet again a concise review of the ‘interesting’ developments in the regulatory landscape.” Mark Sephton / Bard Pharmaceuticals, UK
  • “As always, a full, comprehensive overview of a complicated and fast-moving topic.” David Preston / Bespak Europe, UK

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

A detailed review of the ever-changing regulations

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 Continuing Professional Development (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; including the CT, GMP and Safety Features Regulations
  • EU GMP: Chapters and Annexes; including ATMP GMP and Annexes 1, 17 and 21
  • ICH guidance; including ICH M4E(R2), Q3D, Q12, M9 and M10
  • 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 Tutors

  • 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.
  • Roger Guest; Roger is an expert in GMP and, in particular, the manufacture of sterile medicinal products.

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)  £770.00

DISCOUNTS AVAILABLE
Early bird and multiple delegate booking discounts available. Discounts also offered to NHS staff, regulators,
charities and some self-funding individuals – contact us for details

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