九州影院

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 in February, May, September and late November.  Your subscription will start with the next available update.  The updates will be provided as recordings through NSF鈥檚 online LMS portal and can be viewed at a time convenient to you. To access the recorded updates, 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 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.

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

Prerequisites

For any queries regarding entry requirements for both QP training and/or postgraduate qualifications please contact [email protected]

Additional information

NSF delivers instructor-led QP courses with blended training methods, in a mix of virtual and in-person courses. Please visit for current dates. If you cannot see your delivery method of choice, please contact [email protected]