This course provides recent updates on the EU Clinical Trial Regulation, other EU, MHRA and FDA requirements, consideration for managing Covid-19 for studies in the future and technology developments
10 Mar 2022 + 2 more dates
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 legislation and guidance and will look at how these developments have been implemented. Topics covered will include the latest update of the EU Clinical Trial Regulation, the final EMA TMF guideline and the further renovation of ICH GCP R2. The programme will also examine 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, 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.
Dr Laura Brown is an independent QA and training consultant and director of the MSc in Clinical Research, School of Pharmacy, University of Cardiff. Laura has many years’ experience of managing GCP inspections in the pharmaceutical industry and has worked for several leading companies including GSK, Hoechst Marion Roussel, Good Clinical Research Practices and Phoenix International. She has worked as a clinical research manager, audit director and head of a training department. She is an international expert on GCP and clinical trial requirements and was chair of the Institute of Clinical Research GCP Forum for six years. Laura writes regularly on clinical research regulatory requirements and has written a chapter in International Pharmaceutical Product Registration and several articles on the EU Clinical Trial Regulation, Brexit, and ICH GCP R2.
10 Mar 2022
09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
04:30-12:00 New York (UTC-05)
Course code 11585
Until 03 Feb
16 Jun 2022
London venue TBC
00:00-00:00 UK (London)
Course code 11379
Until 12 May
22 Sep 2022
00:00-00:00 UK (London) (UTC+01)
01:00-01:00 Paris (UTC+02)
19:00-19:00 New York (UTC-04)
Course code 11700
Until 18 Aug
[Laura] is a good presenter, she has world of knowledge. She was also able to get open discussion with the participant which made the course more interesting.
Sep 24 2021
Director, Clinical QA, MEI Pharma
Mar 29 2019
Very good and worthwhile attending.
Research Governance Manager, University Hospitals Plymouth NHS Trust
Sep 25 2018
It was understandable and fullfiled my expectations. I received many useful links and publications, which I can search for. The content was good but a bit too much information in a short timeslot.
Lead CRA, Octapharma Pharmazeutika Produktionsges.m.b.H.
United States of America