About This Course
Keeping up with the changing legislation for clinical trials provides challenges for all those working with investigational medicinal products. This highly interactive training course teaches you all you need to know about international GMP regulations and requirements for the manufacture, control, storage and distribution of medicines to be used in clinical trials manufacture.
Using practical exercises (e.g. the Tic Tac double dummy packaging exercise), our clinical trial GMP training tutors help you to gain a better understanding of the ever-changing world of clinical supply and its legislation. Our tutors are ex-MHRA inspectors and experts in the field of clinical trials manufacturing and regulatory requirements, and teach you simple and pragmatic ways of working designed to help you better meet the needs of the regulators.
Come and join us in Amsterdam to gain a thorough understanding of GMP requirements for clinical supplies or just to keep up-to-date with what’s changing in this area.
This course is approved by the Royal Society of Chemistry and is suitable for its members’ continuing professional development.
Key Learning Objectives
On completion of this course, delegates will know and understand:
- The legislation and guidance around clinical trials and what is changing
- The interpretation of GMPs suitable for clinical trials
- The phases in clinical trials and how requirements change
- Auditing and control of clinical trial operations
- The areas of interface between GMP and GCP requirements and how these should be managed
- Clinical batch releases
- What are they?
- Phases of clinical development
EU Legislation Impacting Clinical Supplies
- The new CT Regulation 536/2014
- The current CT Directive 2001/20/EC
- The GMP Directive 2003/94 and the proposed changes
Annex 13 Requirements for IMPs
- EU and FDA expectations compared – What’s changing?
Product Development and Design
- Product and process understanding
- Risk-based thinking
Supply Chain Management
- Controls on starting materials
- Controls on contractors
- Importation requirements
- Sourcing comparators
- Release procedures
- Quality/technical agreements
GMP Requirements for APIs
- Section 19 of EudraLex Vol 4 Part 2
GMP Considerations for Clinical Manufacture
- Minimising cross-contamination
- The application of ICH Q10
- The importance of risk management
- The importance of the change management system
- Protecting the patient and the trial data
Packaging and Labelling
- Controls of packaging components
- Printing and label controls
- Blinding issues
- Practical considerations
- Stability testing and expiry dating
- How much testing is required?
- How much and how soon?
- Process validation
- Analytical method validation
- Cleaning validation or verification
- What is in an IMPD?
- The importance of a product specification file
Data Integrity in Clinical Trial Manufacture
- What is it and why is it important?
Release Procedures and the Role of the QP
- QP responsibilities
- Two-stage release process
- Use of IVRS
The GMP/GCP Interface
- Issues that fall in the interface
- Audit findings in this area
Shipment to Clinical Sites
- Cold chain supplies
Typical Regulatory Inspection Findings
Darren Jones - Darren is an ex-MHRA GMP Inspector and has audited dosage forms for both commercial and clinical trial applications. Darren also has a wealth of practical knowledge and experience applying GMP in the clinical development world gained during his 18 years with AstraZeneca, prior to joining the MHRA. He was a Qualified Person for IMPs and knows the real challenges and how to overcome them.
Richard Funnell - Richard spent 11 years with the MHRA, including seven as a Senior GMP Inspector with the lead for IMPs. Richard has current knowledge and understanding of what inspectors are looking for in the lead up to the new clinical trial regulations.
Course cost (excluding VAT) £2470
Early bird and multiple delegate booking discounts available. Discounts also offered to NHS staff, regulators and charities– contact us for details.
Have a question or want to book a place? Contact firstname.lastname@example.org
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