Roundtable: External Ethics and Compliance Perspective 2 - Third Parties - CROs Moderator: Dave O’Shaughnessy, VP Compliance, Quintiles Panel Members: Dr. Douglas Peddicord, PhD Executive Director, ACRO Association of Clinical Research Organizations Dr. John Poland, PhD Senior Director, Regulatory Policy Covance UK clinical development services

THE PROMISE OF THE NEW HEALTH A Great Opportunity to Discuss Third Party Views and Challenges THE PROMISE OF THE NEW HEALTH CROs provide very diverse services to sponsors/healthcare companies Basic research, all aspects of clinical research and the associated regulatory requirements, laboratory/analytical work, submissions/registrations of products, support for marketing, market access, medical communication and educations, sales forces etc. CRO have extensive experience of working in regulated environments (GxP etc.) Dealing directly with government agencies and their expectations (in regulatory interactions, regulatory inspections) etc. Alongside and/or on behalf of sponsors Sponsor / CRO Strategic partnerships, preferred provider models have increased Challenge of creating an effective ethics and compliance interface Strategically, operationally, and governance Opportunity to explore some aspects today 6/19/2018 Success in the New Health It requires being: honest enough to acknowledge the challenges innovative enough to build new solutions, and courageous enough to implement them And to do so even when it means taking the road less traveled. The old ways of doing business in our industry either aren’t working as well or aren’t working at all anymore. The New Health requires a new approach. And that’s what we deliver.

To change this title, go to Notes Master 6/19/2018 Given the importance of third parties to pharma/healthcare companies, this session aims to provide an opportunity for the audience to hear directly from ACRO on:   Sharing views and perspectives on the importance of ethics and compliance Providing some views/feedback on how sponsor/customer expectations are received / impact CROs Exploring any ideas on how this may continue to improve Giving the audience an opportunity to think about how best to engage third parties/CROs as they meet / execute their compliance oversight obligations / responsibilities

Transparency & Data Privacy For third parties / CROs – do you fully understand the interfaces, relationships and dependencies? Audience invited to explore the following topics with the panel: Transparency & Data Privacy Third Parties – R&D, GxP, ABAC, FMV, Disclosure R&D – Commercial Interface – Medical Affairs, Medical Governance Global /Regional / Local Challenges – post-marketing surveillance, late phase studies