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Wednesday, June 29 • 2:00pm - 3:00pm
#354: Protocol Optimization: Making It Real

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Limited Capacity seats available
Component Type: Workshop
Level: Intermediate

Increasing complexity in clinical trial protocols makes implementation and reporting difficult. The lack of consistency across protocols compounds the issue. TransCelerate BioPharma Inc. has released a Common Protocol Template that provides a common structure and model language. The common protocol template is a foundational element in the longer-term movement towards an electronic protocol. Participants will rotate through interactive, discussion-based stations to learn about the Common Protocol Template and inform its future development. Topics will include:


• Implementation: benefits and overcoming common challenges
• Technology Enabled Edition: how content reuse and metadata capture is possible today
• Experience from the Trenches: lessons learned and FAQs about the template.

**Due to session format, seating will be limited to 50 participants and available on a first come, first served basis. Once all seats are occupied, DIA will be required to close the session, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Explain the value of harmonizing protocols across industry; Discuss the TransCelerate Common Protocol Template; Identify implementation challenges and strategies for overcoming them.

Chair

Robert L. Ferendo

Speaker

Facilitator
Virginia Nido, MS

Facilitator
Stacy J. Tegan

Facilitator
Bryan Yee


Chair
avatar for Robert Ferendo

Robert Ferendo

Consultant-Process & Technology, Eli Lilly and Company

Speakers
avatar for Virginia Nido

Virginia Nido

Head, Industry Collaborations, Genentech, A Member of the Roche Group
Virginia Nido is the Global Head of Industry Collaborations Management for Roche Product Development. In this role, Ms. Nido is accountable for strategic oversight of external collaboration initiatives. Ms. Nido serves on the Oversight Committee of TransCelerate Biopharma and the... Read More →
avatar for Stacy Tegan

Stacy Tegan

Sr. Manager, Regulatory Technology Consulting, Accenture
Stacy Tegan brings 20+ years of experience in the Pharmaceutical industry with expertise in Regulatory Operations, Clinical Development Processes, and Project Management. Starting in Regulatory Operations, she managed sponsor and outsourced publishing teams and led multiple transitions... Read More →
avatar for Bryan Yee

Bryan Yee

Strategic Planning and Operations Senior Manager, Amgen Inc.
Over the past 10 years Bryan has led global cross-functional teams in the design and implementation of large-scale transformation initiatives at Amgen. He is currently a member of a team focused on creating a best-in-class clinical development capability to bring more medicines to... Read More →

Wednesday June 29, 2016 2:00pm - 3:00pm EDT
Exhibit Hall A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 22: Engage and Exchange, Workshop