Process points: Pharmaceutical industry targets global regulatory affairs

More than 200 pharmaceutical industry professionals and global regulators are expected to gather in the Czech Republic this fall to discuss global regulatory affairs.


More than 200 pharmaceutical industry professionals and global regulators are expected to gather in the Czech Republic this fall to discuss global regulatory affairs. The conference, the first global regulatory GMP event sponsored by the International Society for Pharmaceutical Engineering (ISPE), will take place in Prague, Sept. 19-21, 2005.

The 3-day meeting will include regulatory and industry insights presented by European, U.S., and Japanese regulatory experts and leading global pharmaceutical manufacturers. A variety of issues affecting the pharmaceutical industry now and in the future will be on the agenda.

“We decided it was high time such a meeting of minds was held in Europe, particularly when globalization of the pharmaceutical industry continues at a rapid pace, the European Union has expanded to 25 countries, and with the increasing influence of India and China on the international regulatory and manufacturing environment,” said Paul D’Eramo, executive director, Johnson and Johnson USA and Chair of the ISPE Board of Directors. “The event is geared towards maximum interaction between regulators and industry professionals, with a mixture of presentations, round table discussions, panel discussions, and workshops planned,” he said.

Topics to be discussed include new regulatory initiatives and achieving international harmonization. Also planned are seminars on opportunities in future science-based API (active pharmaceutical ingredients) manufacture, GAMP (good automated manufacturing practices) Good Practice Guide for laboratory systems validation, biopharmaceutical facilities, and more. A table top exhibition will accompany the conference.

Click here for more information or to register .

—Jeanine Katzel, senior editor, Control Engineering,

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