Pharmaceutical Legislation Update Subscription Service

About This Service

You can register for this service all year round! Pharmaceutical legislation and regulatory authority guidance are continually changing. These changes, and their interpretation, 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 pharmaceutical regulatory training provides you with 12 months of updates of changes to legislation and guidance that have the potential to impact the manufacture and distribution of medicinal/drug products. A full update for the past year and a summary of what is new each quarter will be provided in February, May, September, and late November. Your subscription will start with the next available update.

The updates are provided as recordings through NSF’s online LMS portal and can be viewed at a time convenient to you. We will create an account for you on our LMS and, as each update is made available, you will receive an enrolment email giving you a link to access the material. There will also be an opportunity for Q&A with Pete Gough through a live two-hour virtual meeting each quarter.

This training provides essential information for Qualified Persons and other quality professionals employed by organizations that manufacture or distribute medicinal/drug products.

This service is Royal Society of Chemistry approved as suitable for its members’ continuing professional development (CPD).

Key Learning Objectives

To understand and discuss the current interpretation of recently implemented and proposed changes to legislation and guidance which has the potential to impact the manufacture and distribution of medicinal products. This includes changes from:

  • EU medicines legislation: Directives and regulations
  • EU GMP guidance
  • The impacts of Brexit on biopharmaceutical processes and supply chains across the EU and the UK
  • ICH guidance
  • US drug legislation and FDA guidance
  • UK medicines legislation and 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

Tutor

Pete Gough - Peter has almost 50 years’ experience in the pharmaceutical industry and for over 20 years has been responsible for advising senior management regarding changes to pharmaceutical legislation and guidance.

  • The virtual role out of the pharmaceutical update has been a real triumph. The ability to watch and pause the presentations at my own leisure, to allow notes to be made and guidance documents to be looked up at source, has made a huge difference in enabling me to understand and digest the content.
    Peter Tyler
    Seqirus
  • These online courses make it so much easier to review and go back to key elements. The pace is great, and a great balance of slides and extra content in the discussion. I have enjoyed the Question and Answer sessions, and will continue to subscribe to this service. Thanks so much Pete.
    Jennifer Hynes
    Catapult, UK
  • I have always thoroughly enjoyed Pete's courses and this is no exception. With his, what's appears to be endless, pool of experience and knowledge in the field, he has an astonishing knack of interpreting the most ambiguous, often disjointed and seemingly incomprehensible legislation into a thoroughly understandable and user-friendly format.
    Daniel Clarke
    Viatris
  • I really like this being available in this format and the subscription model. I hope this is continued as an option even after we can travel and meet again.
    Emma Maloney
    Fujifilm
  • Invaluable training from Pete. Presented at the right level to aid understanding and provoke thoughts and considerations at own site.
    Nicola Kiernan
    Sartorius
  • I really enjoyed the course and it’s great to go back and look more than once to help with understanding and learning.
    Jennifer Howcroft
    GSK