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#AQCSummit2013
!
!
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

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Avoca Quality Consortium Agenda May 8th Members-only meeting

  • 1. Avoca Quality Summit – Consortium Members Meeting – Agenda – May 8, 2013 Page 1 of 3 #AQCSummit2013 ! ! 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
  • 2. 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
  • 3. 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