by Mike Bennoson

ISPE's first Global Regulatory GMP Conference presents a unique opportunity to meet regulators and senior industry professionals from Europe, the U.S., Japan, and India. Under the theme “New Regulatory Initiatives and Achieving International Harmonisation,” this conference will feature important regulatory and industry insights from leading global pharmaceutical regulators, manufacturers and experts.

The GMP Conference provides an exceptional opportunity for networking, best-practice exchange and in-depth learning. Participants can raise issues of their interest during panel discussions and interactive sessions, and receive immediate feedback from regulators and pharmaceutical industry presenters.

The Plenary Day on 19 September has an excellent group of seven regulators presenting from the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMEA), the Japanese MHLW, the World Health Organisation (WHO), the Pharmaceutical Inspection Cooperation Scheme ( PIC/S ), the German Regulatory Agency and the International Conference on Harmonisation ( ICH ).

Day Two on 20 September will include presentations from eight eminent pharmaceutical industry speakers on a wide range of topics affecting the current global industry including interfaces between regulators/industry, global inspections, quality systems, Q7A and international harmonisation, supplying investigational medicinal products, method for prioritising GMP inspections, ISO standards and pharmaceutical manufacture in Asia.

Day Three on 21 September will be devoted to a concluding panel discussion followed by round table forums to enable in-depth discussions with regulators, industry speakers and fellow delegates.

Do not miss the opportunity to attend this significant event and gain a competitive edge in your organization by being updated on the rapidly changing regulatory and pharmaceutical industry environment. It is a major coup for ISPE to have so many leading professionals willing to share their knowledge and experience to a global audience, expected to be more than 200. For registration information, go to: www.ispe.org/goto_pragueconferences.

About the Author
Michael J. Bennoson joined ISPE in May 1996 and supports the European office in the development of European educational programs and ISPE links with regulatory authorities. Bennoson obtained a Bachelor of Technology degree in industrial chemistry from the University of Bradford, England. He emigrated to Montreal, Canada where he spent four years in quality assurance at Ayerst Laboratories. He then emigrated to New Zealand and established GMP inspections for the government as head of inspection for the Department of Health. Upon his return to the UK, he joined Wellcome (now GSK) in quality assurance, retiring as director of quality assurance operations, UK in December 1995. Bennoson was chairperson of the UK industry GMP Committee for 13 years and participated in a number of European working groups.