Pharmaceutical Legislation Update Subscription Service
About This Course
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 portal and can be viewed anytime. There will also be an opportunity for Q&A 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).
Q3 Full update available from Sep. 10, 2021
Q3 Live Q&A on Sep. 24 | 13:00 to 15:00 UK time
Q4 Interim update available from Dec. 1, 2021
Q4 Live Q&A on Dec. 10 | 13:00 to 14:00 UK time
Q1 Full update available from Feb. 11, 2022
Q1 Live Q&A on Mar. 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
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
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.
Pharmaceutical Legislation Update Training in Italy
This annual one-day pharmaceutical legislation update course, presented in Italian, is ideal for the busy QP or pharmaceutical quality professional who wishes to refresh their knowledge of pharmaceutical law and regulations.
Giovanni Cosmi - Giovanni has 25 years of diversified experience in pharmaceutical quality operations management with several domestic and international companies. He has worked at operational and strategic levels within these for the review, maintenance and improvement of quality systems to ensure compliance on FDA and EMA current Good Manufacturing Practice (cGMP) expectations.
Discounts offered to NHS staff, regulators and charities.