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. Full updates will be provided in February and September, with interim summaries in May and December. The updates will be provided as recordings through NSF’s 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 with Pete Gough through live two-hour virtual meetings 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).
Program
Q1 Full update available from February 11, 2022
Q1 Live Q&A on March 3 | 13:00 to 15:00 UK time
Q2 Interim update available from May 9, 2022
Q2 Live Q&A on June 1 | 13:00 to 14:00 UK time
Q3 Full update available from September 9, 2022
Q3 Live Q&A on September 22 | 13:00 to 15:00 UK time
Q4 Interim update available from November 30, 2022
Q4 Live Q&A on December 8 | 13:00 to 14:00 UK time
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
- U.S. 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 over 45 years’ experience in the pharmaceutical industry and for nearly 20 years has been responsible for advising senior management regarding changes to pharmaceutical legislation and guidance.
Price and Discounts
Price: £1020 excluding VAT (where applicable)
Charities, NHS staff and regulatory bodies are entitled to a 50% discount. (Proof will be required).
