Globalization of clinical trials has increased dramatically in the past 20 years.
Horsham, PA (PRWEB) November 28, 2012
DIA will host Strategic Planning and Partnering in Global Clinical Trials: Compliance with Ethical, Quality and Regulatory Standards conference December 3-4, at the Sheraton Philadelphia Downtown Hotel, 201 N. 17th St., in Philadelphia. The conference will focus on the ideal approach to achieving trial safety and quality while meeting the standards necessary for the regulatory approval of new products.
Globalization of clinical trials has increased dramatically in the past 20 years. That means sponsor companies are conducting studies in multiple regions, including emerging markets. This multiregional approach introduces challenges, including complex and changing regulatory requirements, concern for study quality, and human subject protection dilemmas. This conference will also focus on the strategy and planning processes required for successful entry into multiple markets simultaneously.
Albert J. Allen, Senior Medical Fellow at Bioethics & Pediatric Capabilities at Eli Lilly and Company, and Michelle Roth-Cline, Pediatric Ethicist for the Office of Pediatric Therapeutics at the Food and Drug Administration (FDA), will kick-off the conference by exploring the elements of planning to ensure quality and effectiveness in human subject protection programs.
Over the two-days sessions will include:
- Human Research Protections in the Middle East, presented by Stuart Horowitz, Managing Director, Western Institutional Review Board;
- What Triggers a Health Authority Inspection in a Particular Region, presented by Ann Meeker-O’Connell, Acting Associate Director, Office of Good Clinical Practice Compliance, FDA;
- Importance of Compliance with Regulatory Requirements of EU, presented by Agnès Saint Raymond, Head of Human Medicines Special Areas European Medicines Agency, European Union.
Register for Strategic Planning and Partnering in Global Clinical Trials: Compliance with Ethical, Quality and Regulatory Standards.
ABOUT DIA: DIA is a neutral, global, professional and member-driven association of nearly 18,000 professionals involved in the discovery, development and lifecycle management of pharmaceuticals, biotechnology, medical devices and related health care products. Through our international educational offerings and myriad networking opportunities, DIA provides a global forum for knowledge exchange that fosters the innovation of products, technologies and services to improve health and well-being worldwide. Headquarters are in Horsham, Pa., USA, with offices in Basel, Switzerland; Tokyo, Japan; Mumbai, India; Beijing, China; Washington, D.C.; and Latin America. Visit our website at diahome.org; follow DIA on Facebook, Twitter (#druginfoassn), LinkedIn, Flickr and YouTube.