Trial Master File Institute - San Francisco

Enhance TMF Professional Competencies and Knowledge Base Through Tergeted Learning and Skill Development


San Francisco (Burlingame), CA, United States

The work of TMF professionals 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 marketplace, globalization among a plethora of other stressors. Companies are leveraging eTMFs and other evolving technologies for the quality management systems and for monitoring trials for Inspection Readiness.

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. The institutes are a response to the evolving nature and shifting demands being place on TMF professional.

The TMF institute offers professional development, education and training to course participants from a particular echelon or with a particular purview. The courses are objective driven -designed to develop targeted skill sets, knowledge base, and savvy that is most necessary for participants of that course. The 8-hours of instruction, structured networking and peer-to-peer learning ensure that participants will learn what they need to know and be able to do upon returning to work.

We are proud to be able to bring the TMF Institute to the west coast this spring and hope to see you there.

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/eTMF Systems Management
  • Clinical Document Management
  • Clinical Trial Documentation
  • Clinical Trial Administration
  • Clinical/TMF Project Management
  • Quality Control/Quality Management
  • Clinical Operations
  • Clinical Research Coordination/Management
  • Regulatory Affairs/Operations
  • Clinical Trial Coordination
  • Business
  • Process
  • Trial, Document and Records Management
  • Clinical Document Coordination
  • Clinical Trial Compliance
  • Clinical Development/Study Management
  • Quality Assurance/Control/Operations
  • R&D Quality Management
  • Strategic Operations and Planning
  • Global Development
  • R&D IS Management
  • Archives

Speakers

  • Donna Dorozinsky, President - JUST IN TIME GCP
  • Robin Farmer, Associate Director, Document Control and Training - DYNAVAX TECHNOLOGIES
  • Michelle Ingraham, Manager, Information Governance and Compliance - PPD
  • Lisa Leete, Clinical Research Associate - XENCOR
  • Alex Markiel, Director, Clinical Operations, Head of Clinical Document Control - PHARMACYCLICS
  • Lisa Mulcahy, Owner and Principal Consultant - MULCAHY CONSULTING
  • Emily Roberts-Thomson, VP, Clinical Operations - ACERTA
  • Jolanta Strus, Associate Principal Clinical Scientist - Merck
  • Wendy Trimboli, Director, Head of TMF Management and Compliance - EISAI
  • Melissa Umbehauer Chiasson, Senior Manager, Process, Training and Compliance - TAKEDA
  • Michele Weitz, Senior Director GCP, Compliance Operations - CLOVIS ONCOLOGY

Venue

Hyatt Regency San Francisco Airport
1333 Bayshore Highway
Burlingame, CA 94010

Designed for on-the-go guests, Hyatt Regency San Francisco Airport is a sleek hotel just five minutes from SFO. Feel at home in rooms and luxury suites with bay views and access San Francisco International Airport and downtown Burlingame with complimentary shuttle and trolley service. Take advantage of ample meeting space and chic dining options.

To make reservations guests can call 650-347-1234 or 877-803-7534 and request the negotiated rate for ExL's TMF Institute San Francisco.

To make reservations online Click Here

The group rate is available until April 23, 2019. Please book your room early as rooms available at this rate are limited.