Announcing CHI’s Clinical Auditing Forum, June 2-3, 2015, Boston, MA

NEEDHAM, Mass. - April 2, 2015 - PRLog -- Cambridge Healthtech Institute (CHI) released today the agenda for its Clinical Auditing Forum that will take place on June 2-3, 2015 at the Omni Parker House in Boston, MA, as part of the fourth annual Clinical Trial Oversight Summit where 250+ highly targeted decision makers will be in attendance.

Agenda at-a-Glance:

Tuesday, June 2

Implementing Risk-Based Auditing
Dirk Gille, Vice President, Head Bioresearch QA, Janssen R&D, Belgium

Risk Management: An ICH Perspective
Bob Figarotta, Senior Manager, Clinical, Allergan

Rethinking CAPA Metrics and TMF Metrics: Are You Measuring the Right Things?
Linda B. Sullivan, Co-Founder & President, Metrics Champion Consortium (MCC)

Case Study: Building an Effective CAPA Management Process
Federico Feldstein, J.D., Vice President, Medical Regulatory Compliance, Pfizer, Inc.

Risk-Based Monitoring and Quality Management Systems
Denise M. Shelley, MS, Clinical Project Manager II, Clinical Research Directorate, Clinical Monitoring Research Program (CMRP), Leidos Biomedical Research, Inc., Frederick National Laboratory for Cancer Research

Dinner Short Course: Quality by Design in Clinical Research: Is This Only for the Protocol?

Wednesday, June 3

Avoiding the Leap from 483 to Warning Letter
Robert Romanchuk, BSHS, CCRC, CIP, CHRC, Vice Chair, Schulman Associates, IRB

Sponsor Oversight: The Importance of Auditing in Vendor Management
Beverly Brown, Manager, Global Regulatory Quality, Allergan

Decrease Audit Traffic and Increase Audit Value through Broader Audit Scope and Exchange of Information
Dr. Barbara Heumann, Managing Director, GXP-Engaged Auditing Services GmbH
Debra Ploss, Quality Manager, GXP-Engaged Auditing Services GmbH

Risk-Based Audit Planning: Developing a Three Year Strategy
Rita Farrell, Compliance Specialist, Global Quality & Regulatory Compliance – Clinical Trials & Safety (GQRC-CT&S), Bristol-Myers Squibb

Randomized Controlled Trials: Ethics, Consenting, Maintaining the Blind, and Protocol Adherence
Jerri B. Perkins, M.D., former Medical Officer, FDA

Managing Global Inspections
Janis A. Little, MS, Vice President, Global Regulatory Quality, Allergan

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-Forum.

About Clinical Trial Oversight Summit

Cambridge Healthtech Institute's fourth annual Clinical Trial Oversight Summit will feature four co-located conferences covering best practices and recent trends relevant to clinical research monitoring, auditing, clinical quality assurance, site management, and vendor oversight. This three-day summit will brings together 250+ highly targeted decision makers  and include presentations, case studies, interactive breakout discussion groups, dinner short courses, and networking opportunities. Themes throughout will include risk-based approaches to clinical trial management, implementing quality systems-based approaches to GCP compliance, ensuring reliable study data, responding to the evolving regulatory landscape, and preparing sites and clinical research partners for inspection-readiness.

About Cambridge Healthtech Institute (CHI)

Cambridge Healthtech Institute (CHI), founded in 1992, is the industry leader in providing superior-quality scientific information to eminent researchers and business experts from top pharmaceutical, biotech, and academic organizations. Delivering an assortment of resources such as events, reports, publications and eNewsletters, CHI's portfolio of products include Cambridge Healthtech Institute Conferences, Barnett Educational Services, Insight Pharma Reports, Cambridge Marketing Consultants, Cambridge Meeting Planners, Cambridge Healthtech Media Group, The Knowledge Foundation, and OpenHelix. http://www.chicorporate.com