Announcing CHI's Clinical Trial Auditing Conference, May 10-11, 2016, Boston

NEEDHAM, Mass. - March 22, 2016 - PRLog -- Cambridge Healthtech Institute (CHI) released today the agenda for its Clinical Trial Auditing conference to be held on May 10-11, 2016 at the Westin Boston Waterfront Hotel in Boston, MA, as part of the fifth annual Clinical Trial Innovation Summit.

Confirmed Presentations:

CO-PRESENTATION: ICH E.6 Addendum & Change Management towards a Metrics Based Future
Andy Lawton, Global Head, Data Management, Biometrics & Data Management, Boehringer Ingelheim Ltd.
Jean Baumann, Change Management Specialist, JMB Consulting, LLC

CAPA as Part of Quality Systems in Academia
Johanna L. Stamates, RN, MA, CCRC, CHRC, Executive Director, RCQA (Research Compliance and Quality Assurance), University of Miami

Use of Quality Investigations for Implementing CAPAs in Good Clinical Practice
Linda Hook-D'Innocenzo, MS, RQAP-GCP and GLP, Director, GCP Compliance, Forum Pharmaceutical

Moving Away from a "Conventional" Approach to Auditing in Clinical Trials
Janis Little, Vice President, Global R&D Quality, Allergan

Science-Based Auditing of Clinical Trials
Amer Alghabban, Vice President, GxP QA, Compliance & Training, GxP Quality Assurance, Karyopharm Therapeutics Inc.

A Collaborative Audit Approach of Central Laboratory Partners
Roxana Duque, Compliance Specialist, GQRC-Clinical Trials & Safety, Bristol-Myers Squibb

Partnering Quality with Our Quality Partners: Managing Clinical Trial Quality through Oversight and Collaboration with Our CRO Partners
Derek Hall, Associate Director, Quality Assurance GCP, Incyte

Presentation to be announced by Unanet

Issue Escalation for Fully Outsourced Studies
Rosemary Dillon, Associate Director, Clinical Outsourcing & Operations, Bristol-Myers Squibb

Vendor/Sponsor Performance Metrics: How Are We Doing?
Randy Krauss, Director, Clinical Process Optimization, Shire

PANEL DISCUSSION: Project Tracking and Establishing Appropriate Metrics from Both the Sponsor & CRO Perspective
Randy Krauss, Director, Clinical Process Optimization, Shire
Timothy S. LaCroix, MBA, Head, Business Development, PharPoint Research, Inc.
Linda Hook-D'Innocenzo, MS, RQAP-GCP and GLP, Director, GCP Compliance, Forum Pharmaceutical

Writers and editors are invited to attend. To request a press pass, email Lisa Scimemi, lscimemi@healthtech.com.

For details on sponsorship, exhibit and lead generation packages, contact Ilana Quigley, Tel: 781-972-5457, iquigley@healthtech.com.

For more information, visit http://www.clinicaltrialsummit.com/clinical-auditing.

About Clinical Trial Innovation Summit

Cambridge Healthtech Institute's Fifth Annual Clinical Trial Innovation Summit will bring together leaders from across pharma, biotech and academia to share case studies and best practices on effective clinical trial management and vendor oversight. The 2016 program focuses on key issues and opportunities in the clinical trial industry, including patient recruitment, site selection, data integration, mobile technologies, project management, outsourcing, budgeting, quality in trial conduct, risk-based monitoring and auditing.

About Cambridge Healthtech Institute (CHI)

Cambridge Healthtech Institute (CHI), a division of Cambridge Innovation Institute, is the preeminent life science network for leading researchers and business experts from top pharmaceutical, biotech, CROs, academia, and niche service providers. CHI is renowned for its vast conference portfolio held worldwide including PepTalk, Molecular Medicine Tri-Conference, SCOPE Summit, Bio-IT World Conference & Expo, PEGS Summit, Drug Discovery Chemistry, Biomarker World Congress, World Pharmaceutical Congress, Next Generation Dx Summit and Discovery on Target. CHI's portfolio of products include Cambridge Healthtech Institute Conferences, Barnett International, Insight Pharma Reports, Cambridge Marketing Consultants, Cambridge Meeting Planners, Knowledge Foundation Bio-IT World Clinical Informatics News and Diagnostics World.