Course description
Pharmaceutical Legislation Update Subscription 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 training provides you with 12 months of updates on 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 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 a live two-hour virtual meeting each quarter.
This service is Royal Society of Chemistry approved as suitable for its members' continuing professional development (CPD).
Upcoming start dates
Suitability - Who should attend?
This training provides essential information for Qualified Persons and other quality professionals employed by organizations that manufacture or distribute medicinal/drug products.
Outcome / Qualification etc.
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
Training Course Content
Q3 Update available from Sept 9, 2022
Q3 Live Q&A on Sept 22, 2022 | 13:00 to 15:00 UK time
Q4 Update available from Nov 30, 2022
Q4 Live Q&A on Dec 8, 2022 | 13:00 to 15:00 UK time
Q1 Update available from Feb 10, 2023
Q1 Live Q&A on Mar 2, 2023 | 13:00 to 15:00 UK time
Q2 Update available from May 8, 2023
Q2 Live Q&A on May 31, 2023 | 13:00 to 15:00 UK time
Q3 Update available from Sept 8, 2023
Q3 Live Q&A on Sept 28, 2023 | 13:00 to 15:00 UK time
Q4 Update available from Nov 29, 2023
Q4 Live Q&A on Dec 13, 2023 | 13:00 to 15:00 UK time
Course delivery details
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.
Why choose NSF International, Health Sciences
Trained over 1,300 delegates on our CQI and IRCA certified GMP PQS lead auditor training course
Provided expert health sciences training for over 30 years
More people have become ‘Qualified Persons’ in Europe through our training programme than any other training provider
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Reviews
Average rating 4.9
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 e...
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 astoni...
Expenses
Discounts
Discounts offered to NHS staff, regulators and charities.
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 guid...