Trial Master File Summit
Agenda
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| Day One – Thursday, January 19, 2012 | |
| 8:00 AM | Registration Opens & Continental Breakfast for Workshop Participants |
| 9:00 AM | Pre-Conference Workshop |
Working with External Partners, Joint Ventures, and Mergers Yours, Mine, and Ours: Preparing for TMF Success in Partnerships, M&A, and Multiple CROs. Led by: Carol Smith, Director of Clinical Strategic Sourcing and Systems Management, | |
| 10:30 AM | Networking & Refreshment Break |
| 12:00 PM | Lunch for Workshop Attendees / Registration Opens for Main Conference |
| Main Conference Begins | |
| 1:00 PM | Chairperson's Day One Welcome and Opening Remarks Patricia Brady, Senior International Clinical Trial Manager, |
| 1:15 PM | eTMF AND THE PHARMACEUTICAL INDUSTRY PANEL: Bringing the Pharmaceutical Industry into the 21st Century Moderator Lisa Mulcahy, Mulcahy Consulting, Co-Leader, Panelists Susan Paul, Director, Development BT, TMF Process Owner, Jennifer Embury, CCRP, BSC, Karen Redding, Global Business Development Director, Troy Deck, Founder and CEO, |
| 2:00 PM | INSPECTION READINESS: Right from the Start, Ready all the Time Fran Ross, Continuous Process Improvement Principal Analyst, Clinical Research, |
| 2:45 PM | Networking & Refreshment Break |
| 3:15 PM | ADVANCES IN eTMF TECHNOLOGY: How has Technology Changed to make eTMF More Tenable? Rose-Emily Calo, MBA, PMP, Independent Project Management Consultant, |
| 4:00 PM | STANDARDS: Facilitating the Process of Information Sharing in Outsourcing and Drug Development Collaborations Donald Palmer, RAC, Associate Director Regulatory Systems, |
| 4:45 PM | PORTALS OVERVIEW: How Integrating Portals can Facilitate Communication and Filing David Gwyn, Vice President R&D and Collaborations, |
| 5:30 PM | Close of Day One |
| Day Two – Friday, January 20, 2012 | |
| 9:00 AM | Chairperson's Recap Patricia Brady, Senior International Clinical Trial Manager, |
| 9:15 AM | What are the Different Structures of eTMF Systems? Patricia Brady, Senior International Clinical Trial Manager, |
| 10:00 AM | Training, Measurement and Accountability in Trial Master Files Lisa Rakebrand, MLIS, Associate Director & eTMF Business Owner, Global Clinical Operations,JOHNSON & JOHNSON |
| 10:45 AM | Networking & Refreshment Break |
| 11:15 AM | Coordinating with External Partners (such as CROs) Jennifer Embury, CCRP, BSC, INDEPENDENT CLINICAL RESEARCH CONSULTANT |
| 12:00 PM | PROCESS IMPROVEMENT AND MASTER FILES: Streamlining TMF Filing to Reduce Non-Value-Add Tasks and Inefficiency Throughout the Drug Development Process Carol Smith, Director of Clinical Strategic Sourcing and Systems Management,CEPHALON |
| 12:45 PM | Lunch |
| 1:45 PM | FDA EXPECTATIONS: How can Pharmaceutical Companies File in a Way That Satisfies FDA Requirements Without Creating Excessive Filing Ann Meeker-O'Connell, Acting Associate Director, Risk Science, Intelligence, and Prioritization,OFFICE OF SCIENTIFIC INVESTIGATIONS, CDER/FDA |
| 2:30 PM | REDUCING CLUTTER: What Should be done with Paper After an Upgrade to eTMFs? Lisa Mulcahy, MULCAHY CONSULTING, Co-Leader, |
| 3:15 PM | TAKING CHARGE PANEL DISCUSSION: Where does Responsibility for the TMF Lie Within the Company? Moderator JP Miceli, Manager I, Clinical Business Operations, Panelists Lisa Mulcahy, MULCAHY CONSULTING , Co-Leader, Jason Methia, MS, Manager, Clinical Documentation, Clinical Site Services, Carol Smith, Director of Clinical Strategic Sourcing and Systems Management, |
| 4:00 PM | Conference Concludes |
