Good records management not only has an impact on how effectively an organization manages its records during the conduct of a clinical study; well-managed clinical study records are critical to demonstrating compliance with GCP and other applicable regulations and to supporting regulatory inspections.
This full-day masterclass (comprising interactive seminars, discussions, and group activities) will outline the regulations that relate to Trial Master Files (including best practice guidance and the latest thinking from the European Medicines Agency) and explain how clinical study records can be created and managed to ensure the timely availability of an inspection-ready TMF.
Attendance at this workshop will enable participants to:
-Understand the requirements for clinical study records;
-Comprehend how records can be managed more effectively;
-Learn how to make best use of clinical study records to enhance information sharing and facilitate more efficient operations
-Improve inspection–readiness to avoid resource-intensive preparations when notified of impending audits and inspections
Russell Joyce, Director, Heath Barrowcliff Consulting
Russell Joyce has over 20 years experience in records management across a wide variety of industries (including pharmaceuticals) both as a practitioner and consultant. He is a Director of the Scientific Archivists Group and Executive Committee Member of the Good Clinical Practice Records Managers Association, promoting latest developments, trends, industry best practices and standards in the life sciences sector. Russell has spoken extensively on records management issues for both these groups as well as for the Drug Information Association and the Institute of Clinical Research.
Standard Rate: £599
+44 020 7827 6088