Investigational Medicinal Products

This 3-day Qualified Person (QP) Pharmaceutical Quality Systems training course provides trainee Qualified Persons and other pharmaceutical quality professionals with a thorough knowledge and understanding of the manufacture and supply of clinical trial materials, often referred to as Investigational Medicinal Products, or IMPs. The course meets all of the requirements of the UK Study Guide for trainee QP’s.

It is essential that any pharmaceutical quality professional working in this area has a detailed appreciation of the specific GMP and regulatory requirements for the manufacturer and supply of IMPs. The course 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 anyone working in the field of clinical trials and the manufacture and supply of clinical trial materials.

By the end of this module, you will have a comprehensive knowledge of the GMP and regulatory requirements associated with the manufacture and supply of clinical trial materials.

In assopciation with QPQuandary

Dates available to book

This course is available for in-house presentation, either on-site or virtually. Please contact us for further details.

Key Topics Covered
  • Pertinent legislation related to performing clinical trials
  • Clinical Trial Application (CTA) and the Product Specification File (PSF)
  • Ethical considerations in the design & lifecycle management of clinical trials
  • The different stages of clinical trials
  • Controls surrounding the procurement, storage, distribution and control of IMP, Non-IMPs, placebo, licensed / un-licensed comparators, and rescue products
  • Manufacture and control parameters for each phase of clinical trial, and applying risk management principles
  • Validation and qualification requirements
  • The packaging of clinical trial materials
  • Good Clinical Practice (GCP)
Who will the course benefit?

This course is aimed at trainee QPs as well and anyone working in, or moving into, clinical trial supply and/ or co-ordination roles.  It will also be of great benefit to people involved in the manufacture of clinical trial materials, as well as those managing clinical trial programmes.  

Course Content

Clinical Trial Design & Trial Phases 
Clinical Trial Management 
Protecting the Patient 
Legal Framework for Clinical Trials 
Clinical Trial Documentation 
Manufacture, testing, packaging, labelling, blinding, randomisation of IMP 
Duties and responsibilities of the QP and the Sponsor 
Applying for a Clinical Trial 
IMP Supply Chain 

 

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. 

 

Course Cost

The cost of the Qualified Person (QP) Analysis and Testing training course is £2,100, plus VAT. Course will be charged in GB pounds.

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+44 1635 866699

info@inspiredpharma.com

Inspired Pharma Training Ltd,

5 Westbrook Court, Sharrow Vale Road,

Sheffield, S11 8YZ, United Kingdom.