Past event: Trial Master File Institute - Frankfurt

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

TMF management is becoming increasingly specialised. This specialisation is attributable to a host of factors - globalisation; a matrix of overlapping regional and international regulations; emerging technologies; and interdependence of TMF professionals and professionals in other functional units.

We are expanding the TMF Institute globally to meet the growing demand for targeted professional development, training and education for the TMF professionals and allies. 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. Each of the TMF Institute daylong courses provide information and develop skills essential to specific to a specialized job function or level or responsibility

The TMF Institute consists of a slate of four courses to meet the professional development and educational needs growing TMF community. The instructors and all facets (e.g., content, activities, discussion topics) of each course are determined by what participants need to know and be able to do to excel in a particular purview or echelon.

Who Should Participate

Professionals from pharmaceutical, biotech, and medical device organisations 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
  • Business
  • Trial Records Management
  • Clinical Process
  • Clinical Trial Compliance
  • Clinical Development
  • Quality Assurance/Control/Operations
  • R&D Quality Management
  • Strategic Operations and Planning
  • Global Development
  • R&D IS Management
  • Archives

Instructors

  • Kristen Bretzius, Document Center Manager - PSI PHARMA SUPPORT AMERICA
  • Robin Farmer, Associate Director, Document Control and Training - DYNAVAX TECHNOLOGIES
  • Cristoph Gerdts, IT Business Partner Clinical - BAYER BUSINESS SERVICE GMBH / BAYER AG
  • Martin Hausten, Head of Global Documentation Quality Centre EU - BOEHRINGER INGELHEIM
  • Susan Homminga, Senior Manager of Process Quality, Clinical Medical Quality - GLAXOSMITHKLINE
  • Andreas Jaremo, Associate Director Enablement, TMF Global Lead - ASTRAZENECA
  • Tracey McCulloch, Head TMF Operational Excellence - NOVARTIS
  • Claudia Panitz, Head eDMS Center of Excellence/Regulatory Readiness - NOVARTIS
  • Timothy Rafferty, eTMF Quality and Metrics Manager - ROCHE
  • Eldin Rammell, Director - HEALTH SCIENCES RECORDS & ARCHIVES ASSOCIATION
  • Edith Tapie, TMF Repository Support Lead, TMF Governance Office - NOVARTIS
  • Jamie Toth, Director and Head of TMF Operations - DAIICHI SANKYO
  • Secretary - HSRAA

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Venue

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Venue

Sheraton Offenbach Hotel
AM Busing Palais, Berliner St. 111
Frankfurt/ Offenbach 63065 Germany

You can reach the Sheraton Hotel Offenbach in a short amount of time from Frankfurt Airport or directly from the city centre. 221 air-conditioned rooms in a modern design as well as a suite are provided. You can enjoy rest and relaxation in our spa with sauna, steam room and massage treatments. At the Fitness Center, open around the clock, you can keep your body in shape and exercise for free on the LifeFitness equipment. Otherwise, spend a moment in the sun on our fantastic summer terrace. Incidentally, also known as the most beautiful terrace in the city. Treat yourself to the delicacies of regional and international cuisine as well as dishes in Tapas style at our restaurant, PURE. We also mix delightfully fresh cocktails at our popular OneEleven bar.

To make reservations guests can call +49 69 82999 707 and request the negotiated rate for ExL's TMF Institute. To make reservations online: click here

The group rate is available until February 25, 2019. Please book your room early as rooms available at this rate are limited.
Event details
Organizer : ExL
Event type : Training Course
Reference : ASDE-20295