INC Research, Inc. Addresses Global Health Economics and International Regulatory Pathways for Medical Devices at Drug Information Association 2011

CHICAGO, IL--(Marketwire - June 14, 2011) -

DIA 2011 -- INC Research, LLC, a therapeutically focused contract research organization (CRO) with a trusted process for delivering reliable results, today announced that it will be showcasing its strategic and regulatory expertise, as well as its global expansion at the 47th Annual DIA Meeting in Chicago, June 19-23. The company’s thought leaders are participating in three educational sessions and the executives from Trident Clinical Research, an INC Research company, will be at booth #1217 to discuss the latest trends in clinical research.

INC Research’s principal strategist of medical devices, Dr. Alan Touch, will participate in two sessions within the medical device track. First, he will join Professor Cristina Nunes Ferreria from Scientific Medical Products in Brazil and Diana Valencia, CEO of Latam Clinical Trials in Columbia, in a session on performing medical device trials in Latin America. The session will explore the current regulatory guidelines, timelines, and feasibility of conventional clinical efficacy studies for non-innovative products versus new products or technological innovations. Specifically, Dr. Touch will present an overview of medical device trial regulation and operational challenges in Latin America.

“Understanding Medical Device Trial Regulation and Operational Challenges in Latin America,” will be held on Monday, June 20th from 3:30 - 5:00 p.m. in Room W184d.

Dr. Touch’s second presentation will address the evolvement of medical devices approval and postmarketing requirements globally and offer go-to-market strategies. Dr. Touch, along with Mireille De Cre, director of MDCPartners in Belgium, and Sunita Ahir, regulatory affairs manager of the Premier Research Group in Switzerland, will provide a high-level overview of some key issues facing industry and regulatory agencies in addressing current needs for harmonization to facilitate global market access.

“International Regulatory Pathways for Medical Devices: Understand Changing Landscape to Develop Go-to-Market Strategies,” will take place on Tuesday, June 21st from 10:00 - 11:30 a.m. in Room W184d.

With today’s spotlight on drug costs, industry must justify the health economic value of drug development and new products to payers, physicians, and consumers. Recent initiatives highlight the various financial perspectives industry must consider as it progresses a product through the drug development life cycle.

INC Research’s Geoff Fatzinger, executive director of regulatory affairs and strategic product development for Europe and Asia Pacific, will participate in a symposium on the “Economic Transparency of Drug Development.” Specifically, Fatzinger will discuss how sponsors and CROs are now working closely with finance ministers to evaluate costs and economic impact of clinical trials, which can affect reimbursement decisions and regulatory requirements.

“Connecting Clinical Trials to Health Economics: Why it Makes Sense to Evaluate Drug Development as Part of Health-Care Budget,” will take place Wednesday, June 22nd from 1:30 - 3:00 p.m. in Room W181a.

For more information on INC Research’s strategic and regulatory consulting services, click here. For more information on INC Research’s medical devices and in-vitro diagnostics capabilities, click here. Download our latest white paper, Win with Networked Drug Development Alliances, at www.incresearch.com/networked.

About INC Research, LLC
INC Research is a therapeutically focused contract research organization with a high performance reputation for conducting global clinical development programs of the highest integrity. Pharmaceutical and biotechnology companies look to INC Research for a complete range of customized Phase I through Phase IV programs in therapeutic areas of specialty, and in innovative pediatric and women’s health trials. The company’s Trusted Process® methodology and therapeutic foresight leads customers to more confident, better-informed drug and device development decisions. INC Research is headquartered in Raleigh, NC. For more information please visit www.incresearch.com or follow us at @inc_research.

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