ARCS Conferences

“The importance of PIC/S as a global coordinator in the development of regulatory guidelines (F1)

Synopsis

PIC/S (Pharmaceutical Inspection Cooperation Scheme) celebrated two major events this year; in January 2011 the US FDA became the 39^th member authority of PIC/S; in May 2011 it celebrated its 40^th Anniversary with a major Symposium in Geneva which was attended by many Heads of Agencies, including Dr Margaret Hamburg, US FDA Commissioner. In her keynote address to the Symposium, Dr Hamburg called upon regulatory authorities to cooperate more closely and share information on GMP inspections, in particular in third countries.

Tor Gråberg, the current Chairman of PIC/S, will provide an overview of the PIC/S 40^th Anniversary celebrations, as well as an update on other PIC/S activities; including expected future expansions within PIC/S involving GCP (Good Clinical Practice) and GDP (Good Distribution Practice), and expected changes to the PIC/S GMP Guide and PIC/S guideline documents.

Tor will also discuss the rapid expansion of PIC/S, particularly the interest being shown by regulatory authorities in the Asia Pacific region in becoming members of PIC/S and their move to realign their regulatory requirements to those of PIC/S. The regulatory authorities of NZ, Thailand, Indonesia, Philippines and Taiwan have applied for PIC/S membership and are currently being assessed; the regulatory authorities of Japan, South Korea, Hong Kong and PR of China are expected to apply for PIC/S membership in the near future (the regulatory authorities of Singapore and Malaysia are already members of PIC/S).

The pharmaceutical supply chain is a complex process which spans many geographical regions and involves numerous parties. Most GMP Inspectorates around the world regulate the wholesale distribution part of the supply chain. While various GDP Guides are already available, PIC/S is expected to become more involved in GDP in the future and develop its own GDP Guide.

Mike Arnold, Global Process Head for Pfizer’s Clinical Supply Chain, will present some of the key best practice techniques used in controlling the product flow between various manufacturing organisations and their global customer base.

Mike will discuss supply chain security, including the use of a Quality System approach to help prevent and detect adulteration, counterfeiting, illegal diversion and theft. He will also discuss some recent industry initiatives to develop guidance documents to help ensure supply chain security.

Level of experience: Regulatory and quality professionals – from novice to senior personnel.

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