Announcing CHI's Clinical Trial Auditing Conference, April 24-25, 2017, Boston, MA

NEEDHAM, Mass. - March 8, 2017 - PRLog -- Cambridge Healthtech Institute (CHI) released today the agenda for its seventh annual Clinical Trial Auditing conference to be held on April 24-25, 2017 at the Westin Copley Place in Boston, MA, as part of the sixth annual Clinical Trial Innovation Summit.

Agenda at-a-Glance:

RISK-BASED AUDITING

Risk-Based Approach across Auditing Types
Lydia Milne, Associate Director, Clinical QA, Astellas

Assessing Sites' Electronic Health Records for Clinical Research Readiness
Linda Maziarz, Director, Clinical Development QA, America's Region, CDQA, GlaxoSmithKline

Evolution of an Internal Audit Program
Johanna L. Stamates, RN, MA, CCRC, CHRC, Executive Director, RCQA (Research Compliance and Quality Assurance), University of Miami

PANEL DISCUSSION: Developing a Risk-Based Auditing Plan for Modern Clinical Trials
Moderator: Beverly Brown, Associate Director, Global R&D Quality, Allergan
Panelists: Ana Sharma, Global Head, Strategy and Operations, Clinical Development Quality, Novartis
Linda Maziarz, Director, Clinical Development Quality Assurance, America's, GSK
Lydia Milne, Associate Director, Clinical QA, Astellas

SETTING THE STAGE FOR A SUCCESSFUL AUDIT

Setting the Stage for a Successful Audit: Building Effective Partnerships with Internal/External Stakeholders
Kira Drummond, Sr. Director, R&D Quality Audits and Inspections. Alexion Pharmaceuticals Inc.

AUDITING FOR VENDOR QUALIFICATION AND PERFORMANCE

Vendor Qualification Approaches
Bill Hansen, Outsourcing Compliance and Quality Management, Quality Medicine, Boehringer Ingelheim Pharmaceuticals, Inc.

We Hold This Truth to Be Self-Evident: NOT All GCP Vendors Are Created Equal
Robyn Lori, Director, GCP Vendor Management, Vertex Pharmaceuticals

HEALTH AUTHORITY INSPECTIONS

Actionable Insight from Health Authority Inspections
Janis Little, Vice President, Global Regulatory Quality, Allergan

Lessons Learned from mHealth Canada Health Authority Inspection
Derek Hall, Associate Director, Quality Assurance GCP, Incyte

ICH E6 R2: EFFECTS ON AUDITING

ICH E6 (GCP) Addendum – Impact on Use of Audits?
Andy Lawton, Director and Consultant, Risk Based Approach Ltd

PLENARY KEYNOTE SESSION: Re-Imagining the Clinical Trial Process: Overcoming Challenges to Innovation
Gillian Hodkinson, Vice President, Development Operations, Development, AbbVie
Nina Spiller, Vice President, Clinical Management, Otsuka
Murray Abramson, M.D., Vice President, Global Clinical Operations, Biogen
Spyros Papapetropoulos, Vice President & Global Head, Clinical Development, Movement Disorders & Neurodegenerative Diseases, Teva

Keynote Luncheon Presentation: Leveraging Advanced Data Analytics and mHealth for Next-Gen Trials
Kyle Given, Vice President, Professional Services, Medidata Solutions
Sponsored by: Medidata Solutions

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 and to register, visit http://www.clinicaltrialsummit.com/clinical-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.