Good Clinical Practice (GCP) Symposium – Tuesday, 11 February 2025
Hear from MHRA GCP inspectors on the latest changes to the UK Clinical Trials legislation, an update on implementation of ICH GCP E6 (R3), discussion of hot topics from GCP inspection findings and how GCP inspections will be evolving.
This event is suitable for Individuals working with clinical trials of investigational medicinal products from both commercial and non-commercial organisations.
Participants of the GCP Symposium will learn about:
- Latest Changes to UK Clinical Trials Legislation: Hear directly from MHRA GCP inspectors about the newest updates.
- ICH GCP E6 (R3) Implementation: Discuss the MHRA timeline and plans to implement the new UK Clinical Trials legislation and ICH E6 (R3). Learn what new guidance will be available and what organisations can do to prepare.
- GCP Principles in UK Clinical Trials: Understand how ICH GCP E6 (R3) principles apply in UK Clinical Trials, including expectations on sponsor decision-making and risk-proportionality.
- Key Changes in ICH GCP E6 (R3): Describe the key changes and their applicability to UK Clinical Trials.
- Inspection Findings: Learn from GCP inspection metric trends and hot topics identified on recent inspections.
- Future of GCP Inspections: Understand the future MHRA GCP inspection strategy, how inspections are evolving, and how GCP inspectors are collaborating with other regulators.
The GCP / Labs Symposium is a CPD-accredited event.
Laboratories Symposium – Wednesday, 12 February 2025
Hear from MHRA Laboratory inspectors on GLP requirements and MHRA expectations regarding conduct of GLP studies and analysis of human samples from Clinical Trials, discussion of hot topics from inspection findings, including the challenges seen on inspections of Test Facilities and Laboratories.
This event is suitable for all individuals from industry that are sponsoring and conducting GLP studies in addition to individuals involved in the analysis of human samples from Clinical Trials. The symposium is aimed at Test Facility or Laboratory Management, Quality Assurance, Study Directors, Principal Investigators, Archivists and Scientists. In addition, individuals who provide a consultancy or contract service to facilities
Participants of the Laboratories Symposium will learn about:
- Insights from MHRA Laboratory inspectors on conducting GLP studies and conducting clinical trial human sample analysis.
- Compliance Issues: Recognise the types of compliance issues that Test Facilities and Laboratories face daily and understand how regulators address these issues to maintain acceptable levels of compliance while encouraging innovative and risk based thinking.
- Inspection Findings: Gain a better understanding of the MHRA’s inspections of GLP and Clinical Laboratories and learn about common issues identified during inspections.
- Developing Compliance Approaches: Information provided at the event will help you develop your organisation’s approach to compliance incorporating risk based thinking.
The GCP / Labs Symposium is a CPD-accredited event.
