Past event: Trial Master File Institute - Philadelphia

The work of the TMF professional is evolving in complexity at the same time as it is growing in significance. Individuals and companies must adapt to keep pace with the changing regulations, emerging technologies, the advent of the eTMF, the growth of CROs in the marketplace, globalization and a host of other stressors. TMF management and stewardship is becoming increasingly specialized at the same time as it is becoming more integrated with other clinical functions and beyond.

The TMF Institute is a landmark training course program intended to complement our TMF Summit series. We created the TMF Institute by incorporating what participants like most about the TMF Summit series' workshops into an objective-driven professional growth and learning opportunity.

We hope that you will participate the TMF Institute - Philadelphia this August 12-13, 2019.

Who Should Participate

Professionals from pharmaceutical, biotech, and medical device organizations as well as CROs, vendors, and eTMF/TMF service providers having or seeking responsibilities in the following areas:
  • TMF and eTMF Management
  • Document/Record Management
  • Clinical Trial Administration
  • Clinical Operations
  • Clinical Documentation
  • Clinical Compliance
  • Clinical Business Processes
  • Clinical Research Management
  • Clinical Development/Study Management
  • Quality Assurance/Control/Operations
  • GCP
  • Data Archiving
  • Regulatory Affairs/Operations
  • Competency Development
  • Strategic Operations and Planning
  • Informatics/Clinical IS
  • IT/System Integration
  • Clinical Data Management
  • Alliance Management
  • SOPs/Process Improvement

Instructors

  • June Buchanan, Associate Director, Clinical Operations - TESARO
  • Heidi Dildine, Senior Specialist, Clinical Document Management and Inspection Readiness - TAKEDA
  • Donna Dorozinsky, President - JUST IN TIME GCP
  • Wendy Kelly, Manager, Global Development - SUNOVION
  • Joanne S. Malia, Director, Clinical Documentation Management - REGENERON
  • Lisa Mulcahy, Owner and Principal Consultant - MULCAHY CONSULTING
  • Barbara A. Novak, Senior Manager, Clinical Operations - KYOWA KIRIN PHARMACEUTICAL DEVELOPMENT
  • Vinay Parachuri, Practice Head - Life Sciences - PHARMA TEK SOLUTIONS
  • Jamie Toth, Director and Head of TMF Operations - DAIICHI SANKYO, Secretary - HSRAA
  • Jason Weinstein, Business Lead and Manager, eTMF - REGENERON

Please fill in your name and email to receive the Agenda of this event.

Venue

Sonesta Philadelphia Downtown Rittenhouse Square
1800 Market St, 19103
Philadelphia, PA, USA

Venue

Sonesta Philadelphia Downtown Rittenhouse Square
1800 Market Street
Philadelphia, PA 19103

Explore the comfort and fresh, contemporary vibe at Sonesta Philadelphia Downtown Rittenhouse Square. A premier choice among hotels in Philadelphia, enjoy spacious, modern accommodations and luxurious amenities while staying in the heart of downtown and only steps away from Rittenhouse Square.

To make reservations, guests can call 1-800-SONESTA (766-3782) and request the group rate for ExL's 2nd Trial Master File Institute-Philadelphia. To make reservations online Click Here

The group rate is available until July 22, 2019. Please book your room early, as rooms available at this rate are limited.
Event details
Organizer : ExL
Event type : Training Course
Reference : ASDE-20428