The first workshop for this year’s HSRAA Annual Conference is a must attend for anyone responsible for Trial Master Files (TMFs) in the Health Sciences fields. TMFs have moved from a tertiary office function to a prominent and integral part of the Clinical Research process. With prominence comes visibility, and inspectors, sponsors and CROs are looking!
The TMF Essentials workshop will cover underlying principles, regulatory requirements, and practical issues associated with TMFs. The instructors are Jamie Toth who currently works for Daiichi Sankyo as the Director/Head of TMF Operations, and Eldin Rammell, a freelance, independent Records Management Consultant with his company Rammell Consulting. Together they bring a combined 50 years of TMF experience from the sponsor, CRO and consultancy areas of GxP.
Sarah Curno and Russell Joyce will lead the second workshop, Managing Electronic Records. Sarah, a Records Management Consultant for Hedian Records Management and Russell, the Managing Director of Heath Barrowcliff Consulting Ltd, will bring their collective experience in GCP and records management together to discuss practicalities in managing electronic records. Topics covered include; management of records in a regulated business system, life cycles, templates and management of electronic archives.
You don’t want to miss this opportunity to ensure your company’s Trial Master File is meeting or even exceeding industry standards.