Last update 20 May 2016
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2016 PIC/S Seminar, Manchester (6-8 July 2016) Registrations open

Registrations for the 2016 PIC/S Seminar on "Inspectorates of the Future", hosted by MHRA / UK (Manchester, 6-8 July 2016) are now open (for National Drug Regulatory Authorities only).

For more information: http://www.pics2016.co.uk



Hong Kong SAR / PPBHK and Croatia / HALMED accede to PIC/S

Geneva, 4 January 2016: On 1 January 2016, the Pharmacy and Poisons Board of Hong Kong SAR (PPBHK) as well as the Agency for Medicinal Products and Medical Devices of Croatia (HALMED) became the 47th and 48th PIC/S Participating Authorities.



PIC/S events in Nusa Dua, Indonesia, 5-9 October 2015

Geneva, 24 November 2015: the PIC/S Committee met on 5-6 October 2015 in Nusa Dua (Indonesia). The meeting was followed by the PIC/S annual training Seminar on 7-9 October 2015. The topic of the seminar was "Biopharmaceuticals: Biotechnology and Biologicals: How to Inspect".

The press release regarding these events can be downloaded from the link below:

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Revision of PIC/S GMP Guide

Geneva, 30 September 2015: The PIC/S GMP Guide (PE 009-12) has been revised to incorporate revised Annex 15 and will enter into force on 1st October 2015.

To download the revised GMP Guide (PE 009-12), please consult the page "publications" or click on the link below:

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ICH Q7 Q&A on GMP for API

Geneva, 25 June 2015: ICH has published the ICH Q7 Questions & Answers on Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. PIC/S contributed to this Q&A document which provides interpretation to GMP for APIs since the implementation of the ICH Q7 Guideline. The ICH Q7 Guideline is originally based on a PIC/S draft guideline on API and was adopted by PIC/S in 2001, then integrated as part II of the PIC/S GMP Guide in 2007.

The ICH Q&A document can be downloaded from the link below:

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PIC/S events in Geneva, Switzerland, 11-13 May 2015

Geneva, 3 June 2015: the PIC/S Committee met on 11-12 May 2015 in Geneva (Switzerland). The meeting was followed by a bilateral meeting between the PIC/S Executive Bureau and China / CFDA on 13 May 2015.

The press release regarding these meetings can be downloaded from the link below:

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Mexico applies for PIC/S membership

Geneva, 10 January 2015: On 18 December 2014, Mexico's Federal Commission for the Protection from Sanitary Risks - Ministry of Health (COFEPRIS) applied for PIC/S membership. The Rapporteurs will be appointed by written procedure.



Croatia applies for PIC/S membership

Geneva, 16 September 2014: On 5 September 2014, the Croatian Agency for Medicinal Products and Medical Devices (HALMED) applied for PIC/S membership. The Rapporteurs will be appointed at the next PIC/S Committee meeting on 20-21 October 2014 in Paris (France).


 
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PIC/S Secretariat 14, rue du Roveray CH - 1207 Geneva Switzerland
Tel.: (+41) 22 738 92 16 - Fax: (+41) 22 738 92 17 - E-mail

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