ENGINEERING PHARMACEUTICAL INNOVATION
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What our members say

The unique combination of ISPE's common sense and global presence will make us able to work with regulators throughout the world, as well as small and big companies worldwide. We can combine global presence and global strength with ISPE's abilities to integrate this into people's daily lives.

Gert Moelgaard, Vice President
NNE, Denmark

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True Stories: What it means to be an ISPE Member - (WMV, 16 MB) (Click to begin, or right-click to download and view later)

Regulatory Resources
Regulatory Review

March 2008: Revision of EU GMP Guidelines by Robert M. Tribe

December 2007: PIC/S UPDATE by Robert M. Tribe

August 2007: Update on ANZTPA: Establishment of Joint Australian and New Zealand Regulatory Agency on Hold by Robert M. Tribe

July 2007: A Concise Look at FDA Field Staff by Joseph X. Phillips

May 2007: PIC/S UPDATE: PIC/S Committee Meeting, May 2007 by Robert M. Tribe

February 2007: Japan's Pharmaceutical Affairs Law (PAL): Opportunities and Challenges by Paul D'Eramo

January 2007: PIC/S Update: Committee Meeting & PIC/S-Industry Forum by Robert M. Tribe

November 2006:  US FDA's New Measures to Protect Americans from Counterfeit Drugs by Joseph X. Phillips

September 2006: Restructure of Australia's GMP Inspectorate by Robert M. Tribe

June 2006: PIC/S Update: Düsseldorf Committee Meeting and Seminar by Robert M. Tribe

May 2006: Update on FDA Pharmaceutical cGMPs for the 21st Century - A Risk-based Approach, by Joseph X. Phillips 

March 2006: PIC/S Blueprint, by Robert M. Tribe

February 2006: Pharmaceutical Regulatory and GMP Structure in Russia, by Mike Bennoson

December 2005: A Modern Harmonization Approach to Pharmaceutical Quality and Manufacturing, by Joseph X. Phillips

November 2005: PIC/S Update: Bucharest Meeting and Training, by Robert M. Tribe

October 2005: The World Health Organization - Global QA Guidelines, by Mike Bennoson

September 2005: Pharmaceutical Quality Assessment -- A Science- and Risk-based CMC Approach in the 21st Century, by Joseph X. Phillips

August 2005: Procedure for Accession to PIC/S, by Robert M. Tribe

July 2005: Global Regulatory GMP Conference is Unique Gathering of Worldwide Regulators and Industry, by Mike Bennoson

May 2005: Drug Shortages: a Continuing Challenge, by Joseph X. Phillips

April 2005: PIC/S Approach to Classifying GMP Deficiencies, by Robert M. Tribe

February 2005: An Overview of the International Conference for Harmonization, by Joseph X. Phillips

January 2005: The European Regulatory Environment, by Mike Bennoson

November 2004: ISPE: A Catalyst for Change, by Joseph X. Phillips

October 2004: Growth of the Pharmaceutical Inspection Cooperation Scheme (PIC/S), by Robert M. Tribe

 

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