Qualified Person/QP Pharmaceutical Law and Administration Training CourseThis intensive 3-day 'live online interactive' course provides Pharma professionals with a thorough knowledge and understanding of EU and UK laws related to the manufacture and distribution of medicinal products for human and veterinary use. The course meets all of the requirements of the UK Study Gude for QP's. Key InformationMake Booking
Our intensive 3-day QP Law and Administration training course is aimed at people who need an in-depth appreciation of European and UK Laws related to the manufacture and distribution of medicinal products for human and veterinary use.
The legal side of the manufacture, sale and supply of medicines is a complicated area. With a combination of UK and EU laws to satisfy, it can become very challenging for a Qualified Person to know exactly which laws are, or are not, relevant for the activities that they are undertaking. This course aims to simplify all of this and present the legal side of pharmaceutical manufacturing in a straightforward and interesting way. This three-day virtual course covers the legal and administrative duties that a QP needs to have an appreciation of and is based on, and includes, all of the requirements of the latest UK: Qualified Person Study Guide for trainee QPs. The course is primarily aimed at trainee QPs, but will also be of great benefit to any anyone interested in the legal side of pharmaceuticals, including people working in Quality Assurance, Regulatory Affairs and Clinical Trials.
Key features of our 3-day course
Maximum class sizes
For maximum interactivity and effectiveness, our class size is limited to 10 delegates with at least two tutors. The quality and effectiveness of our courses is unrivalled.
Value for money
Our 3-day course is priced at £1995 – much lower than other alternatives. And with no extra costs of travel, hotels and meals it offers the best value in the marketplace.
Fully up-to-date including BREXIT
This course is totally up-to-date with all recent legislation and in particular the impact of Brexit.
Lively and highly interactive course
Our 3-day format is designed to ensure that this is a lively and highly interactive course with practical workshops and exercises throughout the programme. See the incredible feedback from delegates about our ‘live online interactive ‘ courses in this article.
Take the course at home or your workplace
Avoid travelling to remote locations and staying in hotels. Focus your time on acquiring this critical knowledge and not in your car or the train.
Make a Booking
IN HOUSE COURSES – this course can also be delivered on your site or using our ‘live online interactive’ courseware on a date to suit you. If you are interested please contact us at firstname.lastname@example.org . To see our full range of in-house courses and customisation and delivery method options please visit this page.
Select the tabs below to find out all the details you need to know to make a booking:
The cost of the QP Pharmaceutical Law and Administration training course is £1995 plus VAT. Course will be charged in GB pounds. For full details of what is included in the cost see below.
However delegates from outside the UK but within the European Union (EU) will not be charged VAT if they supply their own company’s national VAT number when booking. VAT will not be charged for any delegates coming from outside the EU.
What's included in cost
The cost includes:
- Course folder containing copies of slides and supplementary notes and handouts.
- Course attendance certificate
- Full tutor support and access during course times.
Payment can be made by cheque, electronic transfer, credit or debit card. Payment must be made before the course start date. Either payment or a Purchase Order number will be required to secure a place on the course.
If you plan to pay by credit card then you should first look at this helpful information.
Alternatively, if you want to discuss any aspect of this training course or want to reserve a place, please send an email with your enquiry or call +44 1635 866699.
Based Outside the UK?
If so, be sure to pick the ‘Tax Exempt’ options in the payment method list when you are making a booking. If you are based in the EU then you must also enter your VAT number to qualify to be exempt from VAT.
Group Bookings - discounts of up to 50%
Book 2 or more individuals from the same company for the same course date to enjoy substantial discounts. The first booking is charged at the full published rate with the second booking charged at full published rate minus 20%. A third or fourth booking is charged at full published rate minus 50%. These discounts are applied automatically when you make a booking.
Key Course Information
Who will the course benefit?
This course is aimed at trainee QPs as well and anyone working in Quality Assurance or Regulatory related roles who need a greater appreciation of the legal side of pharmaceutical manufacturing and supply. It will be of benefit to anyone in QP support roles, including those dealing Marketing Authorisation (Product Licence) applications and updates to existing ones.
09.00 – 16.30 each day
This course provides a comprehensive coverage of the legal side of pharmaceutical manufacturing, sale and supply. Included in this course is how laws are made in the United Kingdom (UK) and the European Union (EU). It also covers how EU laws have been incorporated into UK law over time, as well as more recent ramifications of Brexit. All of the pertinent pharmaceutical laws are covered, with some going into more detail than others. This includes an overview of the Clinical Trials Directive, however the detail of this is saved for our QP: Investigational Medicinal Products course.
The course also includes how to apply for and what is included in a Marketing Authorisation, a Manufacturing and Import Authorisation and a Wholesale Dealer’s Authorisation, including what needs to be done if any changes need to be made to these. In addition, the course covers a wide range of international regulatory bodies and organisations, including their roles with regards to GMP, licencing and inspection. During the course we will cover the role of and legal status of various pharmacopoeias. Also included are the requirements for recalling product from the market and the role of pharmacovigilance and the Regulatory Affairs department. The course also covers specific requirements for veterinary medicines, as well as an overview of medical device legislation and guidance. In addition, the course also covers other relevant sales laws, as well as how the QP needs to keep up to date with forthcoming changes in legislation.
Click on the +icon for more details on each topic:
THE UNITED KINGDOM: RULES, LAWS AND GUIDELINES:
- How laws are made in the UK.
- The UK’s Medicines Act (1968) and subsequent amendments.
- Human Medicines Regulations and Veterinary Medicines Regulations.
- Related pharmaceutical Statutory Instruments.
- The structure of the UK’s MHRA “Orange Guide”.
- How EU Directives have been converted into UK law over time.
- BREXIT and its ramifications
THE EUROPEAN UNION: RULES, LAWS AND GUIDELINES:
- The European Union – history and today.
- EU Regulations and Directives – how they work.
- EU pharmaceutical directives overview.
- Directives 2001/83/EC and 2004/27/EC.
- The GMP Directives (2017/1572 and 2017/1569).
- The EU Guide to GMP.
- The structure of EUDRALEX.
- An overview of the Clinical Trials Directive (2001/20/EC).
- Other Directives of relevance.
- An overview of EU GMP Annexes 16 and 21 and the impact of these for the QP.
AUTHORISATIONS AND LICENCES:
- Marketing Authorisations (Product Licences).
- Manufacturing and Import Authorisations (Manufacturing Licences).
- Wholesale Dealer’s Authorisations (Wholesale Dealer’s Licences).
- Other authorisations, such as for Specials and Importers.
- Updates and variations to authorisations.
- Technical and regulatory considerations for pharmaceutical product lifecycle management (ICH Q12).
- The ramifications of BREXIT with authorisations and licences.
- Supply of medicines to and from the UK and EU (and vice-versa).
- Supply of medicines to and from Northern Ireland (and vice-versa).
REGULATORY BODIES, GROUPS AND INSPECTION:
- The UK’s Medicines and Healthcare-products Regulatory Agency (MHRA).
- The European Medicines Agency (EMA).
- The United States Food and Drug Administration (FDA) and USA GMP.
- Registration of products in the United States.
- Other GMPs and regulatory bodies (such as Japan, Canada, Brazil, Australia and China).
- The International Council on Harmonisation (ICH).
- The Pharmaceutical Inspection Co-operation Scheme (PICS).
- Mutual Recognition Agreements (MRAs).
Trade groups and bodies (such as ABPI, PQG, EFPIA, NICE).
- The British Pharmacopoeia (BP).
- The European Pharmacopoeia (EP).
- The European Directorate for the Quality of Medicines and Healthcare (EDQM).
- Other pharmacopoeias
COMPLAINTS, RECALLS, COUNTERFEIT AND THE FMD
- GMP requirements for complaints and recalls.
- The MHRA’s Defective Medicines Reporting Centre (DMRC).
- Different types of alerts and recalls and actions needed.
- United States Field Alerts.
- The EMA’s CHMP / CVMP guidelines on quality.
- An overview of the Falsified Medicines Directive (FMD).
PHARMACOVIGILANCE AND REGULATORY AFFAIRS
- The role of Regulatory Affairs.
- The role of the Medical Department.
- Good Pharmacovigilance Practice (GPvP).
- Interactions between the QP and these departments
SPECIFIC REQUIREMENTS FOR ANIMAL HEALTH PRODUCTS
- GMP Directives and guidelines (including 91/412/EEC).
- Directives 2001/82/EC and 2004/28/EC.
- The Veterinary Medicines Directorate (VMD).
- The British Pharmacopoeia (Vet).
DISTRIBUTION OF PHARMACEUTICALS:
- Wholesale Dealers Authorisations (WDA).
- EU Good Distribution Practice (GDP).
- The Responsible Person (RP) and Responsible Person for Import (RPi).
- The importance of the legal supply chain.
MEDICAL DEVICES AND COMBINATION PRODUCTS:
- Classes of medical devices.
- Combination products.
- Registration of medical devices.
- Medical device technical files.
- The role of the Notified Bodies.
- ISO 13485 for Medical Devices.
- CE Marking.
- The ramifications of BREXIT.
OTHER LAWS AND REGULATIONS:
- The UK Sales of Goods Act (1979).
- Contract and tort.
- Technical and quality agreements with suppliers and customers.
- Rules regarding the packaging of pharmaceuticals.
- Advertisement and promotional rules and guidelines and the QP’s link to the Marketing Department.
- Control over Control Drugs (CDs).
- Generic and orphan products
- Recent and forthcoming changes to rules and guidance.
- Keeping up to date with forthcoming changes.
A proven and effective training delivery method
Live Online Interactive Training
This course is currently available using our proven and very popular ‘live online interactive’ format. Select the tabs below to find out more:
Stay Safe - Attend from home or whilst at work
With 2 expert facilitators and a maximum of 10 delegates our course will utilise state-of-the art interactive online classroom software that will enable you to:
- chat online with the facilitators and other delegates
- raise your ‘virtual’ hand to ask a question
- participate anonymously in a poll or survey and see an instant display of the class results
- undertake exercises on your own or in a group
And best of all no travel is needed nor a stay in a hotel saving you a lot of time, hassle and money.
As always we will ensure this event is inspirational, enjoyable and educational.
What is involved?
We will send you a link to the live online interactive course with your joining instructions once you have booked your place.
You should log into the training session 10-15 minutes before the start time, to ensure that you have set up the courseware correctly. The course will start precisely on time and it may not be possible to go back over material missed by late arrivals.
Your active participation is expected: everyone will be heard and seen throughout, just as they would be if we were in a room together. To be heard, hear and be seen you will need a microphone, speakers and camera — if you have a modern laptop that’s all you will need. Remember, you’ll need a quiet place to call from and a decent internet connection is a must.
Why choose Inspired Pharma?
Neil is an experienced Quality leader and Qualified Person with over 35 years of pharmaceutical industry experience. He has been a registered QP on several site MIAs and MIA (IMP)s for multiple dosage forms for human pharmaceutical medicinal products, including sterile products, solid dose and ATMPs. Neil also has experience of being a registered QP on a site Man(A) veterinary medicines licence. In addition, he has also acted as a successful QP Sponsor and particularly enjoyed this role.
As well as being a registered QP, Neil has also been named on both UK and Swedish GDP Licences as an RP, and gained substantial GDP knowledge across global supply chains.
During his career he has built extensive knowledge of European and Global GMP and GDP quality systems and has a successful record of team management, including internationally. He has worked for major pharmaceutical companies including GlaxoWellcome, Wyeth, Novartis, Allergan and Boehringer-Ingelheim Animal Health. Neil is also an experienced Corporate GMP Global quality auditor.
Christine started her career with Sanofi Winthrop working in QC over 20 year’s ago, moving through to the QA Department and from there into QP training as her career progressed, finally working as Head of Quality. She has extensive experience of working in both ethical and generic pharmaceutical companies and with a wide range of dosage forms. She is eligible to work both as a Qualified Person (QP) and a Responsible Person (RP), having extensive GMP and GDP experience internationally
Dominic Parry has worked in the pharmaceutical industry since 1992 and is a leading pharmaceutical quality management specialist. He initially worked for Evans Medical Limited as a Production Development Scientist. He then moved to Hoechst Marion Roussel where he worked as a Quality Assurance Officer and then Validation Manager for the sterile manufacturing operations.
Over the past 20 years he has worked as a leading pharmaceutical trainer and Quality Management System specialist. He works closely with pharmaceutical companies and their suppliers on evaluating, developing and continually improving their quality systems so that they add real-value to organisations. He has a real passion for training in the pharmaceutical industry and has presented GMP and Quality Management related training courses all over the world. He is an IRCA registered GMP Lead Auditor and regularly performs audits of pharmaceutical companies and their suppliers.
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About Inspired Pharma
We help people in Pharma organisations to continually improve their regulatory systems to gain competitive advantage and ensure compliance.
We offer a wide range of highly praised and respected classroom and online training courses and also provide our global pharma clients with consultancy support. Our classroom courses are available on a public schedule and also can be customised for inhouse delivery at a client site.
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Our Public Course range
Most of our public courses are currently being delivered using our proven 'live online interactive' courseware enabling you to attend the course from your home or workplace and be heard and seen throughout, just as you would be if we were in a room together. In 2022 we will also begin to offer some traditional classroom courses - see details on each course page.
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Online courses available anytime anywhere
Each course typically consists of 10-20 minute chapters of content followed by a quiz based assessment. The QP courses feature tutor assessment too. The learning is accessed over the internet using desktop computers, laptops, tablets and even smartphones.