URGENT PANDEMIC INFORMATION
In light of the pandemic situation events until September 2021 are cancelled. We will inform customers directly when the events are rescheduled.
COVID CANCELLED: Project Management in Human Resources, Boston MA, Jan 6-8, 2021
COVID CANCELLED: InterDrone, The International Drone Conference, Cambridge MA, Jan 11-13, 2021
COVID CANCELLED: Supplier Management for Medical Device Manufacturers, Cambridge MA, Feb 2-4, 2021
COVID CANCELLED: US Immigration Compliance Strategies, Boston MA, Feb 15-18, 2021
COVID CANCELLED: Project Management Training, Boston MA, Mar 3-5, 2021
COVID CANCELLED: Internal Audit, Fraud Risk Assessment Workshop, Boston MA, Mar 22-25, 2021
COVID CANCELLED: Agile / Scrum Training, Boston MA, Apr 12-14, 2021
COVID CANCELLED: Validation, Verification and Transfer of Analytical Methods, Boston MA, Apr 19-21, 2021
COVID CANCELLED: Computer System Validation - Reduce Costs and Avoid 483s, Boston MA, May 10-12, 2021
COVID CANCELLED: SharePoint Technology Conference, Boston MA, May 26-28, 2021
COVID CANCELLED: Employment Laws Certificate Program, Boston MA, Jun 7-9, 2021
Following events are tentatively planned but may be rescheduled, based on CDC guidelines or attendee registration interest .
TENTATIVE: 21 CFR Part 11 Compliance, Boston MA, Sep 22-24, 2021
TENTATIVE: Quality Control Laboratory Compliance, Boston MA, Oct 6-8, 2021
TENTATIVE: Analytical Instrument Qualification and System Validation, Boston MA, Nov 15-17, 2021
TENTATIVE: FDA's New Import Program for 2021, Boston MA, Dec 7-9, 2021
COVID CANCELLED: Project Management in Human Resources, Boston MA, Jan 6-8, 2021
COVID CANCELLED: InterDrone, The International Drone Conference, Cambridge MA, Jan 11-13, 2021
COVID CANCELLED: Supplier Management for Medical Device Manufacturers, Cambridge MA, Feb 2-4, 2021
COVID CANCELLED: US Immigration Compliance Strategies, Boston MA, Feb 15-18, 2021
COVID CANCELLED: Project Management Training, Boston MA, Mar 3-5, 2021
COVID CANCELLED: Internal Audit, Fraud Risk Assessment Workshop, Boston MA, Mar 22-25, 2021
COVID CANCELLED: Agile / Scrum Training, Boston MA, Apr 12-14, 2021
COVID CANCELLED: Validation, Verification and Transfer of Analytical Methods, Boston MA, Apr 19-21, 2021
COVID CANCELLED: Computer System Validation - Reduce Costs and Avoid 483s, Boston MA, May 10-12, 2021
COVID CANCELLED: SharePoint Technology Conference, Boston MA, May 26-28, 2021
COVID CANCELLED: Employment Laws Certificate Program, Boston MA, Jun 7-9, 2021
Following events are tentatively planned but may be rescheduled, based on CDC guidelines or attendee registration interest .
TENTATIVE: 21 CFR Part 11 Compliance, Boston MA, Sep 22-24, 2021
TENTATIVE: Quality Control Laboratory Compliance, Boston MA, Oct 6-8, 2021
TENTATIVE: Analytical Instrument Qualification and System Validation, Boston MA, Nov 15-17, 2021
TENTATIVE: FDA's New Import Program for 2021, Boston MA, Dec 7-9, 2021
Boston Professional Events List

Operationalize: Electronic Trial Master Files
Date
Aug 16, 2022 - 09:00 AM
- Aug 18, 04:30 PM
Link to Website
Organizer
Hanson Wade
Venue
The Bostonian Boston
Location
26 North Street,
Boston,
MA,
US,
ZIP: 02109
Phone: +1 617 455 4188
Ticket Price: USD 2999.00 - USD 4997.00

As clinical trials get increasingly complex, and outsourcing becomes more prevalent, the number of groups and individuals interacting with TMF widens. Now is the time to drive the industry toward a unified clinical model defined by end-to-end processes and systems, seamless collaboration among stakeholders, and greater insights across the clinical lifecycle.
The Operationalize: eTMF Summit is the first of its kind to unite clinical trial sponsors, CROs, and sites to focus on how technology can be operationalized to break down silos and improve integration and collaboration. In turn, you'll learn how overall TMF health and sponsor oversight can be enhanced to improve inspection readiness.
Join us this August, for over 20 case studies and interactive sessions designed to put a stop to inefficiencies caused by working in isolation. This three-day summit is your chance to increase productivity through collaboration and technology adoption, and ultimately ensure TMFs remain complete and inspection ready during the transition to avoid critical findings and delays.
Exclusive sessions include:
Understand how eTMF and CTMS systems can be integrated to drive a more compliant eTMF - speakers from Beigene and Syneos Health describe how technology can be integrated to best support collaboration internally and between the sponsorS, CRO, and site
Discover key learnings from recent inspections - undertaken by Moderna, Beigene, Syneos Health, and Taysha Gene Therapies
Hear directly from site representatives to optimize collaboration to drive a healthy and inspection ready eTMF- with insights from Suncoast Neuroscience
Associates, Inc, Quality Clinical Research, Texas Heart Institute, and more
Discover how advancing cloud technologies can make your role easier - as speakers from Advanced Clinical tell you about how advances in artificial intelligence and automation can enhance system integration and improve inspection readiness
Tickets https://go.evvnt.com/1148358-2?pid=1052
Brochure https://go.evvnt.com/1148358-3?pid=1052
Prices:
Industry - Conference Only USD 2999.00
Industry - Conference + 1 Workshop USD 3598.00
Industry - Conference + 2 Workshops USD 4197.00
Vendor - Conference Only USD 3599.00
Vendor - Conference + 1 Workshop USD 4298.00
Vendor - Conference + 2 Workshops USD 4997.00
Category: Conferences | Science, Health & Medicine | Pharmaceuticals | Clinical
Speaker Details
JP Miceli, Director of Document Management, Advanced Clinical, Keith Win Manager, Clinical Systems, Daiichi Sankyo, Nisi Nazim, Senior Manager, Global Clinical Operations, BeiGene, Jason Weinstein, Senior Manager TMF Systems & Partner Management, Regeneron, Kate Santoro, Director Clinical Operations TMF, Intellia Therapeutics, Laura Naranjo, Director, TMF Operations, Daiichi-Sankyo, Hobson Lopes, Senior Manager, Regeneron, Jamie Toth, Global Head, TMF Management & Records, BeiGene, Sarah Dean, Executive Director, CTMS & eTMF, Precision for Medicine, Aryn Knight, Administrative Director, Texas Heart Institute, Mallorie Sayre, Senior Manager, Moderna, Matt Lowery, Director of Clinical Research, Suncoast Neuroscience Associates, Inc., Angel Ramos, Senior Manager, Global Records, BeiGene, Monica Alaimo, Senior Director, TMF Operations, Syneos Health, Seneca Harrison, Chief Executive Officer, Quality Clinical Research, Belinda Mabe, Director, TMF Operations, Taysha Gene Therapies, Radwa Aly, Senior Director Clinical Research Operations, GWU Medical Faculty Associates, Tonia Huggins, Director, TMF Operations, Syneos Health
Event Categories
Keywords: technology