About this course
Pharmaceutical law and administration is a key foundation knowledge requirement for all Qualified Persons (QPs). This is clearly spelled out in the relevant article of European Directives 2001/82/EC and 2001/83/EC and in the current Qualified Person Study Guide. The QP must ensure that the relevant laws are being complied with. Thus, a thorough understanding of the laws and legal processes, within Europe and beyond, is essential. This is equally true for other pharmaceutical technical managers.
This extremely popular QP training module is designed to ensure that, in an increasingly changing world, you have a deep and detailed understanding of…
- Why we have medicines laws and what they seek to achieve
- The laws and legislative processes within the EU which impact on medicinal products, and hence the role of the QP
- The UK medicines legislative framework
- US and other international pharmaceutical legislation
- Other relevant laws and guidelines
Why This Training Will Benefit YOU
The Aspiring Qualified Person
- This series of 12 modules held over a 21 month period has been carefully designed to meet the requirements for theoretical training detailed in the latest UK Qualified Person Study Guide and EC Directives 2001/82/EC and 2001/83/EC.
- All our training courses provide practical, face-to-face tuition in sufficient depth to prepare you fully for the challenges that lie ahead.
- Our training is generally considered as the best available and our QPs are held in high regard within the industry.
- As well as being accepted in the UK, our training courses are well known and accepted by several other EU countries, including Ireland, The Netherlands, Austria, Hungary and Malta.
- You are more likely to become a QP with us than with any other training provider!
The Pharmaceutical Technical Professional
- Not all the people attending these courses intend to become QPs. Many use the training to develop as technical managers within other areas of pharmaceutical manufacture and control.
- Increasingly, companies are using these modules as part of a modular technical and professional development plan for their staff.
- Additionally, many industry professionals attend the courses as part of their Continuing Professional Development.
- This course is designed to lead to Postgraduate Certificate, Diploma and MSc qualifications depending on modules taken and work commitment by students. For further details, please contact Stella Pearson-Smith, our QP Course Administrator at [email protected] for more information.
Course outline
European Medicines Legislation
- The legislative framework in the EU
- EU Directives affecting medicines
- Organisation and function of EMA
- Rules governing medicinal products in the EU (EudraLex)
- Importation into the EU and distribution within the EU (wholesale dealing)
- Powers of the licensing authorities and adverse licensing reports
- Pharmacovigilance
UK Medicines Legislation
- Background and development of UK medicines legislation
- MHRA and VMD
Other Relevant Legislation
- US legislation and FDA
- International Conference on Harmonisation (ICH)
- PIC/S
- Medical Devices
Discussion and Working Groups
A significant proportion of the course time will be devoted to group work, where delegates have the opportunity, through case studies, to put theory into practice.
Additionally, discussion periods, including a course trainer panel session, provide delegates with an opportunity to obtain answers to their specific questions and concerns.
Venue
York Marriott Hotel, York, UK
The York Marriott Hotel is within walking distance of York city centre and its many attractions. With 151 stylish guest bedrooms the hotel is ideal for the business or social traveller.
Secure WIFI internet access is available in public areas and their recently refurbished Leisure Club features a heated pool, sauna, steam room, jacuzzi, gymnasium and private tennis court.
Hotel Accommodation
- Online early booking offer – we have negotiated a discounted bed and breakfast rate including free wi-fi.
- To take advantage of this offer, you must book via a special weblink, details of which are provided under the ‘Hotel Bookings’ section at the bottom of this page.
- This offer is only available until four weeks before the course start date, after which point the hotel cannot guarantee room or rate availability.
- If you need any help or guidance with the accommodation booking process, please contact our course administration team.
- Your account with the hotel should be settled at check-out.
- Any charges made by the hotel as a result of you not taking up your reservation for any reason will remain your responsibility, therefore please ensure you are aware of the hotel’s cancellation policy.
Venue Address and Contact Details
York Marriott Hotel
Tadcaster Road
York
YO24 1QQ
England
Tel: +44 (0) 1904 701 000
Fax: +44 (0) 1904 702 308
www.marriott.co.uk
Hotel Bookings
If you would like to benefit from our specially negotiated Bed and Breakfast rate with the hotel, please book your accommodation following “this link - link to be confirmed shortly”
This offer is only available until four weeks before the course start date, after which point the hotel cannot guarantee room or rate availability.
What you've said
“I think sessions versus teamwork ratio was good. Notes were good; detailed and copy of presentations. Lectures were clear and informal. Liz was good at questions raised from candidates. True stories/experience of tutors was good to hear. MHRA panel was interesting to hear things from the ‘other side of the fence’.”
Krishna Halai, Allergan Europe, UK
“Another great course from NSF-DBA.”
Stephen Evans, Benchmark Vaccines, UK
“I really enjoyed the training and I found it very useful. Especially, Liz and Pete impressed me by knowledge and expertise.”
Katerina Dudova, Reckitt Benckiser Pharmaceuticals, Czech Republic
“Everybody who works in QA should have this course and not only people who wish to be a QP.”
Zoltan Jarai, Biogen Idec International, Switzerland
“Comprehensive overview of EU Pharmaceutical Law. NSF-DBA managed to make typically dry law quite interesting and thought provoking – well done.”
Kathryn Cole, Becker & Associates Consulting, USA
“Good course, great knowledge of tutors!”
Arthur Stevenson, Catalent Pharma Solutions, UK
“I really enjoyed the training and I found it very useful.”
Katerina Dudova, Reckitt Benckiser Pharmaceuticals, Czech Republic
“Has brought all my previous knowledge and experience together to bring clarity on subject matter. Would be hugely beneficial for anyone working in QA. Brought to life with real examples.”
Julia Hocking, Boots Contract Manufacturing, UK
“Everybody who works in QA should have this course and not only people who wish to be a QP.”
Zoltan Jarai, Biogen Idec International, Switzerland
“Comprehensive overview of EU Pharma Law. NSF-DBA managed to make typically dry law quite interesting and thought provoking – well done.”
Kathryn Cole, Becker & Associates Consulting, US
“Tutors demonstrated excellent knowledge and aptitude for teaching. Made a dry subject fun.”
Jasbir Rattu, Richmond Pharmacology, UK
“Really great course – a complex subject made enjoyable! Material and support given is excellent.”
Krystyna Woodward, Actavis UK, UK
“NSF-DBA tutors excellent as always. Group activities really helpful in learning to apply learning in real situations.”
Anne Moore, DDD, UK
“Excellent course, very well structured. Information presented in a logical way. You made law interesting which is an achievement in itself.”
Jill O’Mullane, Genzyme, UK
“NSF-DBA manages to make legislation interesting and fun. I have now a much better understanding which legislation and laws exist, where I can find them and how they interact and relate to guidances.”
Brigitte Boxma, MSD Animal Health, The Netherlands
“Great course. I learned substantially and the course exceeded my expectations.”
Carlos Alvarez, Biogen Idec, Switzerland
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