EU and FDA GCP (Good Clinical Practice) and Clinical Research Training Course: ICH GCP R3Hot Inspection Topics Updates (Online Event: May 19, 2026)
Dublin, Jan. 29, 2026 (GLOBE NEWSWIRE) -- The "GCP (Good Clinical Practice) and Clinical Research Update - Hot Inspection Topics Training Course (May 19, 2026)" training has been added to ResearchAndMarkets.com's 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
Certifications:
Key Topics Covered:
Brief review of regulatory authority inspection findings
EMA, MHRA and FDA findings
New ICH GCP E6 R3 draft guideline
Other ICH updates
Data integrity governance
EU Clinical Trial Regulation (536/2014) update
Essential records: EMA key requirements to avoid inspection findings, and documents requirement in ICH GCP E6 R3
Awareness update from EU and FDA
Digitalisation and technology advances and GCP
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 https://www.researchandmarkets.com/r/dvajb3
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