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Health regulatory leaders ready to flock to city

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The top event for regulatory professionals in the health care industry is headed to Indianapolis next month.

The annual conference of the Regulatory Affairs Professionals Society, or RAPS, is expected to draw thousands of members representing 120 companies and organizations, including the U.S. Food and Drug Administration, European Medicines Agency, Korea Food and Drug Administration and China’s State Food and Drug Administration. The event is set for Oct. 22-26.

Representatives from regulatory agencies in Canada, India, Japan, New Zealand, Saudi Arabia, Singapore and The Netherlands also plan to attend.

RAPS usually holds its big meeting on one of the coasts, said Gretchen Bowker, chief operating officer of Pearl IRB, the state’s first commercial institutional review board firm, which pre-screens clinical trials. Last year it drew more than 2,000 regulatory professionals to San Jose, Calif.

Regulatory affairs professionals often aren’t prominent in the public eye, but their role is crucial in helping get potentially life-saving products to the market quicker. Often it can be a regulatory glitch rather than actual product issue that can slow down the process.

“The regulatory person is the mediator between the scientists and the government agency,” said Bowker.

The health care industry has faced a number of hurdles in recent years, including tighter regulation by the U.S. Food and Drug Administration. That’s led some health care firms to first seek approval from European regulatory agencies.

Top FDA officials will attend the conference at the JW Marriott and at the Indiana Conventional Center.

The big meeting is the latest shot in the arm for the state’s regulatory affairs industry. Two weeks ago, the inaugural Indiana RAPS chapter met downtown, with about 50 people attending, including doctors and lawyers from sectors ranging from central Indiana’s pharmaceutical industry to northern Indiana’s orthopedics device sector to medical products firms downstate.

An Indiana-Cincinnati chapter fizzled out about five years ago, with the failure attributed to the group having too broad a geographic focus. The new, Indiana chapter will have a statewide focus and will meet in various locations statewide on a rotating basis, said Bowker, who is the chapter’s chair.

Pearl IRB was founded last year and is headed by Diana Caldwell, who worked with Bowker at Eli Lilly and Co. Pre-screening and clinical trial services in Indiana often have been conducted by medical experts at hospitals and universities.

The Indiana Health Industry Forum has been trying to stoke clinical trial activity and capabilities to support and grow the life sciences and medical device industry in the state.

Indiana lags some neighboring states in trial activity, with 4,556 in process or completed over the last several years, compared with 7,737 in Illinois and 8,206 in Ohio, according to the National Institutes of Health.

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