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.
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| This service is Royal Society of Chemistry approved as suitable for its members’ continuing professional development (CPD). | This service is supported by AFI for AFI members. |
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.
Additional Recommended Courses
Pharmaceutical Law and Administration
This highly interactive four-and-a-half-day course is designed to provide the aspiring Qualified Person and pharmaceutical quality professional with the knowledge and understanding of international pharmaceutical legislation so that they can carry out their duties with skill and authority. We will describe the laws, regulations and guidance that dictate how we must work on a daily basis, we will explain why these laws exist and how they come into being, we will describe the roles and responsibilities of the major international regulatory agencies and we will emphasise the key role that QP and pharmaceutical professionals must play to ensure compliance with international legislation in the interest of patient safety.
Tutors: To be confirmed
Price: £3780 excluding VAT (where applicable)
Course registrations will close 5 working days before the start of the course.
You can view our booking terms and conditions from here.
Multiple Delegate Discounts are available for delegates from the same company attending the same course.
The first delegate must pay full price. The second delegate will receive a 20% discount. The third and any subsequent delegates will receive a 50% discount. Charities, NHS staff are entitled to a 50% discount. (Proof will be required).