Avoca Quality Summit – Consortium Members Meeting – Agenda – May 8, 2013 Page 1 of 3 #AQCSummit2013

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!AVOCA QUALITY SUMMIT

Consortium Members Meeting

Agenda MAY 8th 2013

!!!10:30 AM - 11:00 AM Registration and Continental Breakfast !11:00 AM - 11:20 AM Welcome and Overview of the Day !

! Patricia Leuchten, CEO, The Avoca Group !11:20 AM - 12:00 PM Session 1: Proactive Quality Management and Quality Oversight Through a presentation followed by a moderated conversation, attendees will discuss efforts to drive proactive quality management and quality oversight as well as their experiences and perspectives on best practices, tools, and processes.

! Presenter and Moderator: Steven Whittaker, Director, Avoca Quality Consortium, The Avoca Group

11:20 – 12:00 – Presentation will cover:

! Key interim findings from the Avoca Consortium Member assessment ! Insights gleaned from phone interviews of Consortium Member executives ! Types and categories of Consortium Member processes, documents, and other

efforts to establish proactive quality management and quality oversight

Avoca Quality Summit – Consortium Members Meeting – Agenda – May 8, 2013 Page 2 of 3 #AQCSummit2013

12:00 PM - 12:45 PM Session 2: Insights and Implications – Prequalification and Routine Systems Audits Since its formation, Avoca has collected data on behalf of the Quality Consortium concerning different aspects of quality in outsourced clinical trials. In this session, the findings of the Avoca research related to prequalification and routine systems audits will be shared and the implications will be discussed. Presenters:

! Denise Calaprice-Whitty, Ph.D., Executive Director, Survey Research and Relationship Management Programs, The Avoca Group

! Sidney DeGraw, Senior Consultant, The Avoca Group !

12:45 PM - 1:45 PM Session 3: Working Lunch – Case Studies and Examples During this working lunch, select Member companies will present case studies describing efforts to drive quality management in practice, including implementation of the Consortium Quality Agreement Template as well as successes and hurdles encountered. Participants:

! Merry Chu, M.Sc., Director, Medical Quality, Regional and Third Party Management, Eli Lilly Canada, Inc.

! Grace Crawford, Senior Director, Quality Assurance, ICON Clinical Research ! Deborah Bisio Dwyer, Associate Director, Outsourcing, Cerexa, Inc. (a wholly

owned subsidiary of Forest Laboratories, Inc.) ! Mitchell Katz, Ph.D., Executive Director, Medical Research Operations, Purdue

Pharma L.P. 1:45 PM - 5:00 PM Session 4: The Art and Science of Partnering™ and Masterclass Workshop – How to Create Effective Partnerships Through this interactive workshop, those responsible for quality oversight as well as those managing partnerships, from both sponsor companies and CROs, will have an opportunity to learn more about the skills and approaches needed for effective oversight and management of relationships. The presentation session will be led by Howard Jacobson, Ph.D., a strategy and business consultant and learning and development specialist who has provided Avoca workshops based on the company’s Art and Science of Partnering™ framework for the past ten years. This workshop is designed to provide operational staff with a practical, hands-on learning opportunity, while providing managers and leaders who have greater experience with new insights on best practices for relationship development. !Moderators:

! Howard Jacobson, Ph.D. ! Steven Whittaker

Avoca Quality Summit – Consortium Members Meeting – Agenda – May 8, 2013 Page 3 of 3 #AQCSummit2013

Session 4: The Art and Science of Partnering™ and Master Class Workshop – How to Create Effective Partnerships (continued)

1:45 - 2:00 – Frame the challenge/opportunity (Presentation) 2:00 - 2:30 – Effective concepts/techniques (Presentation) 2:30 - 4:50 – Experiential Exercise

! 2:30 - 3:10 – Assign roles/table, Review prep materials, Establish negotiation strategy & approach

! 3:10 - 3:30 – Break ! 3:30 - 4:30 – Reconvene: Negotiate and document ! 4:30 - 4:50 – Debrief

4:50 - 5:00 – Master Class Summary !5:00 PM - 5:30 PM Recap and Close

! Patricia Leuchten, CEO, The Avoca Group ! Steven Whittaker, Director, Avoca Quality Consortium

6:30 PM Dinner All participants are invited to join us for a dinner hosted by Acurian at: Tre Piani 120 Rockingham Row Princeton, NJ 08540