28-05-2025
GCP (Good Clinical Practice), Clinical Research and Inspection Training Course: Regulatory Compliance, Recent Legislation, and Technological Advances (ONLINE EVENT: July 7, 2025)
Stay ahead in clinical research with our essential course on EU Clinical Trials Regulation and ICH GCP R3 updates. Benefit from expert insights on regulatory compliance, recent legislation, and technological advances. Earn 6 CPD hours and a completion certificate. Reserve your spot today!
Dublin, May 28, 2025 (GLOBE NEWSWIRE) -- The "GCP (Good Clinical Practice) and Clinical Research Update - Hot Inspection Topics Training Course" training has been added to offering.
Clinical research is a constantly evolving field and the regulatory requirements are frequently being updated. In order to stay ahead and maintain your GCP knowledge, it is important to receive regular training.
This must-attend course provides a review of recent changes to relevant guidance and legislation and will look at how these developments have been implemented and are likely to be implemented. Topics covered will include the EU Clinical Trials Regulation and associated documents and an update on ICH GCP R3
This is a highly interactive course suitable for those who need to refresh their knowledge and to demonstrate recent and up-to-date training to regulatory inspectors.
Who Should Attend:
The course is of particular relevance for those working in clinical research, regulatory affairs and pharmacovigilance, QA, Audit, CROs, academic trialists and regulatory inspectors. It will also be of interest to those departments who liaise/support clinical trial personnel and all other professionals who want to know more about updates in GCP regulations and guidelines covering clinical trials.
Benefits of attending
Be updated on ICH GCP R3
Discuss recent developments in GCP and clinical trial legislation and guidance in the EU, FDA considerations
Review the requirements of clinical trail essential documentation
Identify common audit and inspection findings to help prepare for inspection
Understand the EU Clinical Trial Regulation requirements
Clarify requirements for data integrity and governance
Explore technology advances in clinical trials
Certifications:
CPD: 6 hours for your records
Certificate of completion
Key Topics Covered:
Brief review of regulatory authority inspection findings
EMA, MHRA and FDA findings
New ICH GCP E6 R3 draft guideline
What is new and likely to impact on running trials
Revised principles
Data governance
Records and reports
Key updates, additions and revisions
ICH E8
Other ICH updates
European Commission Guidelines on Good Clinical Practice specific to Advanced Therapy Medicinal Products (ATMPs)
ICH E8
Data integrity governance
What inspectors look for
MHRA integrity guidance compliance
ICH GCP R3 Governance requirements
EU Clinical Trial Regulation (536/2014) update
Key changes and documentation
Update since go-live
Clinical Trials Information System (CTIS)
EU clinical trial authorisation
Serious Breaches
Essential records: EMA key requirements to avoid inspection findings, and documents requirement in ICH GCP E6 R3
TMF structure, content, security, control, maintaining the TMF and storage, e-TMFs, archiving and retention
ICH GCP R3 - recommended format for compliance
Awareness update from EU and FDA
EU
EMA Guidance on validation & qualification of computerised systems
European Commission Guidelines on Good Clinical Practice specific to Advanced Therapy Medicinal Products (ATMPs)
Artificial intelligence reflection guidance in lifecycle
Stronger enforcement of the GDPR in cross-border cases
Real-world data
FDA
Guidance for industry: considerations for the use of real-world data
FDA guidance on enhancing the diversity of clinical trials
A risk-based approach to monitoring of clinical investigations
Informed consent guidance for IRBs, clinical investigators and sponsors
Digitalisation and technology advances and GCP
Technology innovations in clinical research
Electronic informed consent
Apps, medical devices and mobile technologies in clinical trials
Artificial intelligence
Decentralised clinical trials
Conclusion and final Q&A
Speakers: Laura Brown Pharmaceutical QA and Training Consultant University of Cardiff Dr Laura Brown MBA, BSc,PhD, is a Pharmaceutical QA and Training Consultant, Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. She has more than 20 years' experience of quality assurance in the pharmaceutical industry and has worked for several companies, including GSKs Hoechst Marion Roussel, Farmitalia and Phoenix International.
She has a particular expertise in quality assurance including risked based approaches to quality systems, data Integrity and project management in the pharmaceutical industry. She regularly writes on pharmaceutical regulatory issues including "The Planning of International Drug Development", in the Clinical Research Manual, Euromed and the "Impact of Brexit", RQA Journal 2017. For more information about this training visit
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