Over the past few years, the work of a TMF professional had grown more and more complex for a variety of reasons (e.g., increasing regulation, emerging technologies, eTMF, growth of CROs in the marketplace). It is safe to say that this trend is expected to continue if not accelerate due to globalization, the advent of using eTMF for oversight, and so forth.
We are proud to announce the launch of the TMF Institute - a landmark professional development program for TMF professionals. The instruction provided of each course will offer comprehensive education and training for participants return to work with the savvy, knowledge and skill sets they need to thrive at work.
Each of the courses of the TMF Institute will provide information tailored for a specialized job function, or that relates to a particular theme. This summer, TMF professionals may select one of the two-day long courses that are offered each day.
Instructors
- Donna Dorozinsky, President, JUST IN TIME GCP
- Liz Farrell, Senior Manager, TMF, BIOGEN
- Renee Fate, Director, Clinical Records Management, ALLERGAN
- Laura Forcade, Clinical Trial Master File Specialist, ALEXION
- Tamika Jackson, President, Corementum
- Jennifer Maier, Associate Director, R&D Quality Compliance, ALEXION PHARMACEUTICALS
- Joanne Malia, Associate Director, Clinical Documentation Management, REGENERON
- Lisa Mulcahy, Owner and Principal Consultant, MULCAHY CONSULTING
- Mark Romano, R&D Customer Success Manager
- Kate Santoro, Clinical Trial Manager, ALKERMES
- Supriya Shoroff, Associate Director, TMF, SAGE THERAPEUTICS
- Brian Souder, TMF Head, MERCK
- Perry Steinberg, Regulated Content Management – General Manager and Product Leader, MEDIDATA
- Jamie Toth, Head of TMF Operations, DAIICHI SANKYO
- Stephanie Viscomi, Associate Director, Clinical Trial Office, IMMUNOGEN
Please fill in your name and email to receive the agenda of this event.
July 11, 2018, 9:00am - 5:00pm (choose one course)
- TMF Foundations: Understand the Fundamentals and Challenges of the TMF, and the Regulations and Guidelines That Govern It
- TMF Leadership: Steward Continuous Improvement Through Oversight and a Shared Culture of Quality With Internal and External Allies
July 12, 2018, 9:00am - 5:00pm (choose one course)
- TMF Operations: Streamline Processes That Promote Inspection Readiness Throughout the Study Life Cycle
- Electronic Records Management: Improve GCP for All Document Archiving and Records Management
The agenda is available as PDF under downloads at the right side of the page.
Venue
The venue is not yet available for this event.
Follow this event to be informed when the venue is available and stay informed on other changes.
Venue
The Colonnade Hotel120 Huntington Avenue
Boston, MA 02116
To make reservations, guests can call 1-800-962-3030 or 617-424-7000 and request the negotiated rate for ExL’s TMF Institute. To make reservations online
Click HereThe group rate is available until June 19, 2018. Please book your room early, as rooms available at this rate are limited.
(617) 424-7000
