Clinical research is a constantly evolving field and the regulatory requirements are frequently 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, the final EU TMF guideline and data integrity. 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)
ICH GCP E6 R2 – update and inspectors’ expectations
Oversight – how to demonstrate CRO oversight and investigator oversight
Risk management – including new requirements
Final EU TMF guideline and data integrity
Q & A and other hot topics – brief overview of other recent GCP developments in the EU and US
Summary, action plans and final Q & A
Dr Laura Brown MBA, BSc (Biochemistry), BSc (Psychology), 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 and regulatory requirements in clinical trials in the pharmaceutical industry. She has worked in senior positions for several companies, including GlaxoWellcome, Hoechst Marion Roussel, Farmitalia and Phoenix International. She has a particular expertise in quality systems including data protection and data integrity in clinical trials. She was Chairman of the ACRPI GCP Forum for six years. She regularly writes on pharmaceutical regulatory issues in clinical trials