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      PIC/S - ASEAN FORUM (22 November)

A half-day meeting between PIC/S and representatives from Regulatory Authorities of the Association of South East Asian Nations (ASEAN) took place in Singapore on 22 November 2007. Representatives from Brunei Darussalam, Indonesia, Malaysia, Philippines, Singapore, Thailand and Vietnam attended the meeting. PIC/S was represented by the Executive Bureau.

This was the first meeting between PIC/S Participating Authorities and ASEAN. It gave the occasion for both PIC/S and ASEAN to present their respective organisation and to explore possible ways of co-operation on GMP training and GMP Guides and Guidance documents. For PIC/S, it is of particular interest to note that ASEAN countries are in the process of harmonising their GMP inspection systems through the negotiation of an MRA taking PIC/S as a reference. A draft MRA is expected by the end of 2007.

Participants agreed to co-operate in the following fields of GMP: training for inspectors (e.g. joint visits or coached inspections), preparation of application for PIC/S membership, sharing of information (e.g. Rapid Alert System, import for export-only products) and sharing of knowledge on the inspection of herbal medicines.

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PIC/S – ISPE JOINT WORKSHOP (23 November)

PIC/S and the International Society for Pharmaceutical Engineering (ISPE) organised in Singapore on 23 November 2007 an interactive joint workshop on “Systems Approach to Quality Risk Management”. It was the first time that PIC/S organised such a joint event with an industry association.

The meeting was open to both regulators and industry. It was attended by more than 226 participants (among which, 65 participants from Regulatory Authorities) representing 34 countries.

Participants attended plenary sessions with presentations from industry and regulatory authority representatives (respectively “Risk Management in Production System, Two Examples” and “Manufacturing of Risky Molecules in Non Dedicated Facilities”). GMP inspectors and industry representatives also participated in practical workshops on different aspects of Quality Risk Management.

The workshop was a success and it is expected that more joint workshops will be organised with professional and industry associations in the future.

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