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Qualified Person (QP) Pharmaceutical Law and Administration training course

This 3-day Qualified Person (QP) Pharmaceutical Law and Administration training course provides trainee Qualified Persons and other pharmaceutical quality professionals with a thorough knowledge and understanding of UK and EU laws related to the approval, manufacture and distribution of medicinal products for human and veterinary use. The course meets all of the requirements of the UK Study Guide for trainee QPs.
Key InformationMake Booking

 

This 3-day Qualified Person (QP) Pharmaceutical Law and Administration training course provides trainee Qualified Persons and other pharmaceutical quality professionals with a thorough knowledge and understanding of UK and EU laws related to the approval, manufacture and distribution of medicinal products for human and veterinary use. The course meets all of the requirements of the UK Study Guide for trainee QPs.

The laws associated with pharmaceutical manufacturing and release can be complicated and difficult to get an appreciation of.  This course aims to break down all of the legislation that a QP needs to have an understanding off, making it all, hopefully, more simple to understand. A QP does not need to know all of these laws word-for-word, but does need to have an appreciation of what they are about and what they are designed to achieve.

By the end of this module, you will have knowledge of the structure and application of current and forthcoming UK and EU legislation relating to the manufacture, control, storage  and supply of medicinal products (Human, veterinary and IMP for clinical trials).

Key topics covered:

  • UK / EU Legislation and guidance
  • Competent authorities
  • Import and export of products
  • Site and product authorisations
  • Defect reporting
  • Pharmacovigilance
 
 

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Booking details

Select the tabs below to find out all the details you need to know to make a booking on this Qualified Person (QP) Pharmaceutical Law and Administration training course:

Course cost

The cost of the Qualified Person (QP) Pharmaceutical Law and Administration training course is £1950, 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:

  • Electronic course folder, containing copies of slides and supplementary notes and handouts.
  • Course attendance certificate
  • Full tutor support and access during course times.

Payment

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 Qualified Person (QP) Pharmaceutical Law and Administration training 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.

Course overview:

  • The structure, content and administration of Marketing and site authorisations (MA, MIA, WDA or equivalents)
  • The role of the UK and EU Regulatory / Licencing bodies (MHRA/VMD/EMA) including procedures for defect reporting
  • Import and export requirements for medicinal products
  • The impact of trade and recognition agreements on import / export requirements
  • The role of ICH and PIC/s
  • Regulations related to Pharmacovigilance and drug safety monitoring

It must be noted that delegates will need to maintain and apply their knowledge to fully meet the requirements of the UK QP Study Guide.

This course is run in partnership with QP Quandary.  You can book from this website or from their website.

If you are interested in booking, click on BOOK NOW above.

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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 began to once again offer traditional classroom courses - see details on each course page.

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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.

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