By Derek Walker

Humans: management, visionaries, acknowledgements and awards -- association -- technique safeguard -- the surroundings -- Regulatory affairs: assembly the U.S. nutrition and Drug management

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Extra resources for The Management of Chemical Process Development in the Pharmaceutical Industry

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For the warehousing and stringent documentation covering receipt, storage, and distribution, we were fortunate to be in the hands of Dennis Von Linden and his staff. No people acknowledgment would be complete without paying tribute to the enormously talented and well-organized administrative assistants I relied on, especially in my Schering years, to ensure that the organization ran smoothly. They were called secretaries, but they took on a much more proactive guidance role, beyond the routine definition of secretary.

Dinesh was one of the few who made time to write papers and publish his work. ) Bill Leong should be mentioned along with Junning Lee, for their efforts within the American Chemical Society, New Jersey local section, and the Sino-American chemistry society, respectively, to promote the profession of chemistry on the larger stage outside the internal activities of their employer. We were fortunate in employing many very talented, hard-working bachelor’s and master’s degree chemists without whom we could not have succeeded.

The other change in the way of thinking was in the Regulatory Affairs area. George was seconded to the Regulatory Affairs Department for several months, where he acquired the insights c02 JWDD078/Walker January 24, 2008 17:50 Char Count= OUTSTANDING SCIENTISTS/ENGINEERS 25 needed to enable Chemical Development to gain a real voice in decisions on what technical information should be included in our INDs and NDAs. On his return from this “sabbatical,” his efforts enabled us to preserve some flexibility in our written submissions to the FDA, especially in submitting information on the early steps of a process.

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