WASHINGTON, Sept. 14 /PRNewswire/ -- The Association of Clinical Research Organizations (ACRO), representing companies that are key participants in the clinical development of new medicinal products, is consulting regularly with European Union regulators and policymakers about the impact of the Clinical Trials Directive on clinical research within an enlarged EU.
Following a June 29, 2004 meeting between ACRO member companies and the leadership of the European Medicines Agency (EMEA), the association submitted formal input to that agency's white paper, Road Map to 2010: Preparing the Ground for the Future. As part of ongoing consultations, representatives of ACRO member companies are set to meet with the Pharmaceuticals Unit of the European Commission in Brussels next month.
"While we enthusiastically support the goals of ensuring a consistent regulatory environment and facilitating innovation in the development of new medicinal products, our members have expressed concern that the current lack of harmonization in implementing the Directive is leading to confusion among sponsors, investigators and others, and creating an adverse perception of the EU as a desirable place in which to conduct clinical research," said Douglas Peddicord, Ph.D., Executive Director of the association. "ACRO is committed to collaborating with European authorities to provide a broad perspective on the clinical research enterprise, and to help enhance the European community's role in international clinical research."
Some of the highlights of the association's input to the EMEA and the European Commission include providing an objective and cross-cutting view on a wide range of compliance issues in relation to the Clinical Trials Directive, given widely varying interpretations of the requirements of the Directive being encountered in EU countries. In its meetings with regulators, ACRO has offered to be both a source of "neutral" (across stakeholder) expertise and a partner in initiatives for the education and training of stakeholders in such areas as pharmacovigilance planning, risk management, novel approaches to clinical studies, the development of innovative products, and the like.
"Ours is a global industry, and ACRO members maintain some 119 offices and employ more than 10,000 people in the EU," said Chris Kuebler, Chairman and CEO of Covance, Inc., and Chairman of the ACRO Board of Directors. "As our membership and influence grows, the association will play a significant role to advance and promote the highest standards for clinical trial outsourcing to policymakers and regulators across the world."
The Association of Clinical Research Organizations (ACRO) fosters continued advancement of medical product development. Member companies, representing a multibillion-dollar global industry, provide a wide range of research and development services to help pharmaceutical, biotechnology and medical device companies bring new drugs and new treatments to patients quickly and safely. ACRO represents the clinical outsourcing industry to customers, regulators, legislators and the public.
To view comments submitted by ACRO to the European Commission, the EMEA and the US FDA, go to: http://www.acrohealth.org/.
Association of Clinical Research OrganizationsCONTACT: Courtney Gray Haupt of the Association of Clinical ResearchOrganizations, +1-202-543-4018, or healthadvocate04@att.net
Web site: http://www.acrohealth.org/
