1Avoca Quality Consortium - Consortium Members Meeting - Agenda - Oct. 10, 2013

FALL 2013: CONSORTIUM MEMBERS MEETINGAGENDA

DATE: OCTOBER 10, 2013WESTIN 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 FrontierThe Consortium’s strategies and focus for 2014

8:30 – 9:00Registration 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

2Avoca Quality Consortium - Consortium Members Meeting - Agenda - Oct. 10, 2013

10:00 – 10:45Implementation 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 – 11:00Break

11:00 – 12:00Session 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

3Avoca Quality Consortium - Consortium Members Meeting - Agenda - Oct. 10, 2013

12:00 – 1:00 Networking Lunch

1:00 – 2:30Session 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 – 2:45Break

2:45 – 3:30Session 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

4Avoca Quality Consortium - Consortium Members Meeting - Agenda - Oct. 10, 2013

3:30 – 4:15Session 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 – 5:00Networking Reception