Clinical research is a constantly evolving field and the regulatory requirements are regularly being updated. In order to stay up to date and maintain your GCP knowledge, it is important to receive regular training.
This course provides an update on recent changes to relevant legislation and guidance and will discuss how these changes have been implemented. Topics covered will include ICH GCP R2, the EU Clinical Trial Regulation, data integrity and the impact of GDPR on clinical trials. The programme will discuss inspection findings and common failings in these new areas and how these should be addressed.
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.
Benefits of attending:
The course is of particular relevance for those working in clinical research, regulatory affairs and pharmacovigilance 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.
Brief review of regulatory authority inspections findings
New EU Clinical Trial Regulation (536/2014) – overview and update including new supporting documents
ICH GCP E6 R2 – practical examples of implementation to comply with inspectors’ expectations
Oversight – how to demonstrate and document for CRO oversight and investigator oversight
Risk management – new requirements for GCP compliance
GDPR (General Data Protection Regulation) requirements for clinical trials
Q & A and other hot topics
Summary, action plans and final Q & A
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.