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New MedDRA Version Available; Implementation and Global Adoption Moving Forward.

DENVER, July 10 /PRNewswire/ --

The Maintenance and Support Services Organization (MSSO) of TRW/Healthcare Solutions announced the release of the Medical Dictionary for Regulatory Activities (MedDRA) version 4.0 and discussed implementation goals with regulatory authorities -- U.S. Food and Drug Administration (FDA) and European Medicines Evaluation Agency (EMEA) -- today during the 37th annual meeting of the Drug Information Association. MedDRA is a global, standardized medical terminology for use in adverse event reporting and clinical data management designed to make communication between international regulatory agencies and pharmaceutical companies more efficient. "The long-term goal is not only to implement a new, more specific coding tool, but also to obtain better data analyses," said Patrick Revelle, Director of Products and Services for the MedDRA MSSO of TRW/Healthcare Solutions. "Accordingly, it addresses a combination of IT and medical issues."

"This latest version of MedDRA underwent an extensive review by the MSSO to evaluate every term in the hierarchy for proper placement," said Patricia Mozzicato, M.D., Medical Professional/Senior Manager, MSSO of TRW/Healthcare Solutions. "We addressed outstanding subscriber comments and focused on higher-level terms being reviewed for adequacy, clarification of NEC and NOS terms, and the addition of new special search categories," she said. Dr. Mozzicato added that additional issues would be addressed with the next version release expected in the fall. MedDRA is currently updated biannually and already contains approximately 50,000 terms, substantially more than other nonstandardized, individual medical terminologies (or dictionaries) being used including COSTART, WHO-ART, J-ART, ICD-9, ICD-9-CM, and HARTS.

Challenges

Pat Revelle addressed the misconception of a "plug and play" approach to MedDRA implementation, underscoring its impact on both the medical and IT side of business. He noted it involved several players within the organization, including data management, drug safety, regulatory affairs, clinical research, and information technology, among others. According to Revelle, MedDRA is not just a replacement; it's a superior terminology. From an information technology standpoint, MedDRA implementation has broader implications in that it may require equipment and software updates to ensure integration and compatibility between departments and require new encoding and browsing tools. Revelle emphasized how important it is for companies to plan their own implementation timetable to avoid creating a "Y2K-type scenario" and risking a drain on resources through forced implementation by mandates. Revelle underscored the benefits companies derive when MedDRA is implemented properly -- a decrease costs over time, better data analyses, more precise communication, and the elimination for the need to reconcile data.

According to Dr. Mozzicato, "MedDRA offers many advantages. As opposed to earlier terminologies constituting about 1,200 terms, MedDRA is far more complex, specific and granular comprising a total of 50,000 terms and requiring training at several levels within the organization." She added, "Although its implementation can be a challenge, the MSSO is poised to assist users. The recent release of version 4.0 assures continued growth and improvement of this promising tool."

Implementation

The European Medicines Evaluation Agency (EMEA) which oversees regulatory activities in the 15 European Union Member countries will mandate MedDRA use for all electronic single-case, adverse event reports beginning January, 2002, and for all paper and electronic reports beginning January, 2003. Pilot MedDRA programs have been implemented involving seven EU countries and 17 pharmaceutical companies. In addition, MedDRA translations have been completed for half of the EU languages and other translations are underway, in addition to user training programs. "For companies intending to market products in Europe, we recommend they rapidly start using MedDRA," said Patrick LeCourtois, Head of the Unit of Pre-authorization of the EMEA. "We already receive more and more reports using MedDRA and, in the future, hope to extend its use to clinical trial reporting and labeling."

The U.S. Food and Drug Administration (FDA) has implemented MedDRA use for its Adverse Event Reporting System and is expected to mandate MedDRA compliance during 2002. Min Chen, R.Ph., M.P.H., Associate Director, Division of Drug Risk Evaluation at FDA, noted that MedDRA training for officers in the FDA review division has begun with MSSO support and that an internal policy on MedDRA use in the future will hopefully be developed soon.

In addition, the Japanese Ministry of Health, Labor, and Welfare is adopting MedDRA/J and moving toward requiring its use and "strongly recommended" use of MedDRA/J in adverse drug reporting beginning at the end of March 2000.

MedDRA was formulated in the early 1990's under the auspices of the International Conference on Harmonisation to address growing communications issues between international pharmaceutical companies and regulators. MedDRA is applicable to all phases of drug development and to the health effects of devices with an emphasis on ease-of-use data entry, retrieval, analysis, and display. MedDRA is now owned by the International Federation of Pharmaceutical Manufacturers Associations, which granted TRW exclusive license as the official provider of MedDRA subscriptions and core services. TRW Healthcare Solutions operates the MSSO division which provides a wide range of MedDRA support services and products as well as providing MedDRA updates, managing change submissions, and providing full-time MedDRA support. For more information about MedDRA and the MSSO, visit www.meddramsso.com.

TRW provides advanced-technology products and services for the aerospace, information systems, and automotive markets. The company, which is celebrating its 100th year of operation during 2001, had year-end 2000 sales of $17.2 billion. For more information, visit www.trw.com.

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