1. 1Avoca Quality Consortium - Consortium Members Meeting - Agenda - Oct. 10, 2013
FALL 2013: CONSORTIUM MEMBERS MEETING
AGENDA
DATE: OCTOBER 10, 2013
WESTIN PRINCETON AT FORRESTAL VILLAGE
Theme 1: Quality “Lift Off’
How to implement and socialize Consortium guidelines and tools for the benefit of Members and sourcing
partners
Theme 2: Collaboration Sustains the Mission!
How Members can share information, challenges and best practices to achieve proactive quality
management
Theme 3: Our Future Frontier
The Consortium’s strategies and focus for 2014
8:30 – 9:00
Registration and Continental Breakfast
9:00 – 10:00
“Reaching New Heights...Together”
Welcome and Overview of the Day, Reaching New Heights Concept, Sharing of Consortium Tenets, Refresher of
Oversight Components and Proactive Quality Management Components Shared in May 2013, and Review of Pulse
Survey Results
This session will include a polling system to obtain on-site responses from Consortium Member participants
on relevant topics.
• Patricia Leuchten, CEO, The Avoca Group
• Steven Whittaker, Executive Director, Avoca Quality Consortium, The Avoca Group

2. 2Avoca Quality Consortium - Consortium Members Meeting - Agenda - Oct. 10, 2013
10:00 – 10:45
Implementation of Guidelines and Tools
Session 1a: Development of Proactive Quality Management and Quality Oversight Guidelines and Tools, and
Adaptation of Quality Agreement Template
Components of Quality Oversight and Proactive Quality Management were shared and discussed during
the May 2013 Avoca Quality Consortium Summit. Through a presentation and interactive discussions, The
Avoca Group will share how Member organizations’ best-practice documents and non-pharma industry
specific best-practices have been selected, refined, and modularized, including discussion of the content
of the guidelines and tools. These best-practice guidelines and tools, as well as an updated, modularized
Quality Agreement template will become available to all Member organizations.
• Presenter: Janis Hall, Senior Consultant, The Avoca Group
Presentation will cover:
• Modular approach
o Guidelines
o Tools
o Quality Agreement
• Examples of modules and contents for key components
10:45 – 11:00
Break
11:00 – 12:00
Session 1b: Implementation of Proactive Quality Management and Quality Oversight Solutions, Demo of Technology
Enabler
In order to truly succeed in the establishment of industry best practices for the delivery of quality in
outsourced clinical projects while also maintaining critical aspects of cost effectiveness and timeliness, it
is necessary to not only provide the guidelines and tools, but to also deliver them in an easily accessible,
versatile, user-friendly, and intuitive medium. It is important to allow each Member organization to tailor
processes and tools to their sourcing business models and their partnership arrangements. During this
session, an IT solution will be shared to demonstrate how The Avoca Quality Consortium web portal will
operate.
• Demo Presenter: Debbie Briffa, Consultant, The Avoca Group
• Moderators of Session at all Member Tables: Debbie Briffa, Danya Burakoff, Janis Hall,
Marnie Kanarek, Per Kreipke, Ann Wang, Steven Whittaker
o Demonstration of The Avoca Quality Consortium web portal, modularized guidelines and
tools, and socialization component of the tool
o Table moderators will assist individuals in using their own PCs to access and experiment with
the web portal capabilities and reviewing the modularized documents; debrief at the end
to obtain feedback on the capabilities as well as suggestions for refinement
o Brief demonstration of potential document publishing capability that Avoca is evaluating
(use of modularized Quality Agreement template); intent is to obtain Consortium Member
level of interest in this functionality

3. 3Avoca Quality Consortium - Consortium Members Meeting - Agenda - Oct. 10, 2013
12:00 – 1:00
Networking Lunch
1:00 – 2:30
Session 2: Socialization of Proactive Quality Management and Quality Oversight
During the May 2013 Quality Consortium Summit, the concept of “socialization” arose in order to
successfully ensure best-practices become incorporated into the cultural norm for Member organizations
and their partnerships. During this session, Steven A. Jacobs will present about cultural and human
behavioral aspects of socialization. Also, selected panel members will share their perspectives and
experiences in socializing best-practices across complex organizations and partnerships.
• Presenter: Steven A. Jacobs, MBA, R.Ph., President, Global BioPharm Solutions, LLC
• Member Conversation Moderator: Steven Whittaker, Executive Director, Avoca Quality
Consortium, The Avoca Group
• Member Conversation:
o Sarah Carter, Executive Director, Planning and Platform Services, Global Development
Operations, Amgen
o Deborah Bisio Dwyer, MBA, Associate Director, Outsourcing, Cerexa, Inc.
o Steven A. Jacobs, MBA, R.Ph, President, Global BioPharm Solutions, LLC
o Tony Owen, Vice President Clinical Quality Assurance, Quintiles
o Denise Sharp, Associate Director, Pediatric Program, Cerexa, Inc.
1:00 – 1:45
• Presentation will cover: Concepts and examples of socialization of best practices and change
initiatives within large, complex organizations
1:45 – 2:30
• Moderated conversation with Members
2:30 – 2:45
Break
2:45 – 3:30
Session 3: Quality Metrics – Pfizer Case Study
Background information will be presented regarding how Avoca Quality Consortium Quality Metrics were
derived, including perspectives based on additional research and investigation. The Avoca Group and
Pfizer will co-present a Pfizer Case Study, introduce a Quality Metrics framework for consideration by the
Consortium Members, and engage the attendees in a discussion regarding best practice approaches to
developing robust metrics programs.
• Presenters
o Denise Calaprice-Whitty, Ph.D, Senior Consultant, The Avoca Group
o David Nickerson, Senior Director, Quality and Risk Management Lead, Clinical Quality
Management, Pfizer, Inc.
• Presentation will cover
o Concepts for design and utilization of Quality Metrics
• Facilitators
o Denise Calaprice-Whitty, Ph.D, Senior Consultant, The Avoca Group
o Steven Whittaker, Executive Director, Avoca Quality Consortium, The Avoca Group

4. 4Avoca Quality Consortium - Consortium Members Meeting - Agenda - Oct. 10, 2013
3:30 – 4:15
Session 4: Strategies and Focus for 2014
Review of Pulse Survey results focused on 2014 initiatives and open discussion.
Theme 1: Breaking down risk silos within organizations and between sponsors and providers.
Theme 2: Reducing the level of complexity in quality management and implementation of clinical trials
while enhancing quality outcomes.
During this session, a polling system will be used to obtain on-site interest from Consortium Member
participants on potential 2014 topics.
4:15 – 5:00
Networking Reception