QP Module 11: Investigational Medicinal Products

About this course

The adoption of Council Directive 2001/20/EC means that:

• All clinical trial materials must be made in accordance with the principles of GMP
• Manufacturing facilities must hold an appropriate authorisation and will be subject to inspection by the regulatory authorities
• All investigational medicinal products must be subject to certification by a Qualified Person prior to release into a trial

This course is designed to provide existing, trainee and transitional Qualified Persons with the foundation knowledge and understanding required to assess and certify investigational medicinal products and to appreciate the fundamental differences between IMPs and licensed products. It will also be of value for other technical staff working with clinical trial supplies.

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

The Clinical Trial

• The phases of clinical trials
• Impact of trial design on manufacturing and packing operations

Regulatory Framework

• Directives 2001/20/EC and 2005/28/EC
• Annex 13

Role of the Qualified Person

• The legal duties
• Key documentation – the CTA, the IMP dossier and the Product Specification File
• Control and certification of products manufactured or sourced outside the European Union
• The two stage release process
• The role of the QP in split manufacture and in virtual companies
• The special challenges

Good Manufacturing Practice

• Sourcing of materials, including comparators
• Production and quality control of IMPs
• Packaging issues – blinding and product security
• Validation – how much, how soon?
• Assigning and extending shelf life
• Retains and returns
• Assessing ‘equivalence’ of GMP standards

Good Clinical Practice

• What is GCP?
• The GMP/GCP interface – when do the responsibilities of the QP end?

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 tutor panel session, provide delegates with an opportunity to obtain answers to their specific question 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.

Tutors

We believe that our team of experts are the best available. Not only have they got years of experience in the industry, but they are committed to tutoring and helping those inside the industry to improve and raise the standards. We understand that you attend courses to learn about the latest regulations and to get your questions answered.

Our expert for this course are:

• 

  Mr Mike Halliday
  Executive Director
  BSc (Pharm), MRPharmS, PGDip

  • [email protected]
  • +44(0)1751 432999
• 

  Mrs Liz Allanson
  Consultant
  BSc (Pharm), MRPharmS

  • [email protected]
  • +44(0)1751 432999

What you've said

“It was the best course I have ever done. Great.”

Sonja Glanzmann, Merck, Switzerland

“Buzz groups very useful - specifically the ‘tic-tac’ one. Good interactive course and tutors/guest speakers - good to see their news and implementation of regs and problems encountered at their sites.”

Donna Stewart, Almac Group, UK

“Excellent outline and breakdown of issues facing IMP QPs, will be of real value going forward.”

Bertie Craig, Newcastle University, UK

“I found the delivery by the tutors, the knowledge of the guest speakers and the course materials to be of a very high standard.”

Ming Ng, Forest Laboratories, Republic of Ireland

“Very useful course. A whole new world has been opened. It also changed a wrong perception that IMPs follow lower GMP and are less complex. Thank you.”

Nuno Furtado, Baxter Healthcare, UK