Fundamentals of Clinical Outsourcing West

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Agenda at a Glance

Fundamentals of Clinical Outsourcing West Agenda at a Glance

DAY ONE PROGRAM AGENDA: Monday, November 9, 2009

WORKSHOPS: SELECT FROM A or B

8:30	Workshop Registration & Morning Coffee	12:30	Workshop Concludes; Luncheon for Workshop Participants
9:00	Workshop Begins	12:30	Workshop Concludes; Luncheon for Workshop Participants
10:30	30-Minute Networking & Refreshment Break	1:00	Registration for Main Conference Only Participants
WORKSHOP A: Contract Approach and Development: Key Terms and Negotiating Strategies Workshop Leader Frederick Dorey Special Counsel COOLEY GODWARD KRONISH, LLP

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1:30	Chairperson’s Opening Remarks Rikki Hansen Bouchard President & CEO, RH BOUCHARD & ASSOCIATES, INC.
1:45	Map the Clinical Development Outsourcing Process Gary Laine, Director Clinical Sourcing, Contracting and Payments, ELAN PHARMACEUTICALS
2:30	Understand the Different Outsourcing Models Rikki Hansen Bouchard President & CEO, RH BOUCHARD & ASSOCIATES, INC.
	3:15 Networking & Refreshment Break
3:45	Create a Corporate Outsourcing Strategy Gavin Choy, PharmD Vice President, Clinical Operations, SUPERGEN
4:30	KEYNOTE ADRESS: Tracking the Transition from Transactional to Portfolio- Based Relationships Ken Getz MBA, Senior Research Fellow, TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT
5:30	Day One Concludes

DAY TWO PROGRAM AGENDA: Tuesday, November 10, 2009

8:30	Chairperson’s Opening Remarks Rikki Hansen Bouchard President & CEO, RH BOUCHARD & ASSOCIATES, INC.
8:45	The Benefits of a Establishing a Governance Committee Christina S. DiArcangelo Associate Director, Clinical Contracts and Outsourcing, FIBROGEN
9:15	External Service Provider Identification, Assessment and Selection Ira Snyder, CPM Senior Manager, Clinical Outsourcing OTSUKA PHARMACEUTICAL DEVELOPMENT & COMMERCIALIZATION
10:00	Networking & Refreshment Break
10:30	Budget Basics and Outsourcing Tools and Content of Templates Deborah Dwyer Associate Director of Clinical Outsourcing, CEREXA Daniella Ajib, MBA Manager, Clinical Outsourcing, CEREXA
11:15	Developing Scope of Work for a Solid Project Foundation and Minimal Project Setbacks Jessica Y. Kaman Senior Director, Development Outsourcing, EXELIXIS
12:00	Luncheon
1:15	Relationship Management: The “Rules of Engagement” Todd Georgieff Associate Director, Clinical Trial Management, GENENTECH Lauren Meyers Strategic Relationship Manager, Development Outsourcing and Contracts, GENENTECH
2:00	FDA ADRESS: What Does FDA Expect Regarding Quality Oversight of Third Parties? Michael Marcarelli Director, Office of Bioresearch Monitoring, CDRH, FDA
3:00	Conference Concludes

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