【速報】PIC/S/4月のジュネーブ総会報告

※追記更新(2018.05.12)
※追記更新(2018.05.16)
5/9付でPIC/S本部から「PIC/S meetings in Geneva, Switzerland, 16-18 April 2018」と題して、本年4/16-4/18にジュネーブで開催された総会報告がPress Releaseされています。
ハイライトは以下の通りです。
ちなみに、ガイド改訂版や新規aide-memoire等については、「2018年7/1付発効」となっておりますが、発効前にウェブサイトの“Publications”に掲載すると通知されています。
・New PIC/S guidance on GMP inspection reliance based on draft by ICMRA with aim to maximise inspection resources for GMP compliance of overseas facilities.
・Revision of PIC/S GMP guide (PE009). Chapters 3, 5 and 8 of the PIC/S GMP guide have been revised with entry into force on 1 July 2018; along with adoption of transposition for pic/s purposes of EU guidances on GMP exicipent risk assessment, exposure limits and GDP for API.
・New PIC/S working group established with WHO to revise Annex 2 on biologicals and ATMP.
・Limited stakeholder consultation for draft PIC/S guidance on data integrity
・New PIC/S aide-memoire on cross-contamination in shared facilities.
・New PIC/S pre-accession application received from Pakistan / DRAP.
・New PIC/S working groups to be established on whistle-blowers/confidential informants; quality defects procedures; as well as PIC/S assessment and re-assessment procedures.
・PIC/S 2018 seminar to be hosted by US FDA in Chicago and other news in the field of training for GM(D)P inspectors.
また、PIC/S本部のPress Releaseに合せて、英国MHRA/Inspectorate Blogに「PIC/S press release following April 2018 meeting」と題するブログがアップされています。
興味のある方は、下記URLsのPress Release並びにプログをご参照ください。
●PIC/S News「PIC/S meetings in Geneva, Switzerland, 16-18 April 2018」
https://www.picscheme.org/en/news
●Press release「PIC/S Meetings in Geneva (Switzerland)」~pdfファイル
https://www.picscheme.org/layout/document.php?id=1394
●5/9付英国MHRA/Inspectorate Blog「PIC/S press release following April 2018 meeting」
https://mhrainspectorate.blog.gov.uk/2018/05/09/pic-s-press-release-following-april-2018-meeting/
【5/12付追記更新】
5/11付のRAPSが「PIC/S Adopts New Guidance on GMP Inspections」と題して記事に取り上げています。
興味のある方は、下記URLのニュース記事をご参照ください。
https://www.raps.org/news-and-articles/news-articles/2018/5/pics-adopts-new-guidance-on-gmp-inspections
【5/16付追記更新】
5/14付のGMP Publishingが「PIC/S Meeting in April 2018」と題して記事に取り上げています。
興味のある方は、下記URLのニュース記事をご参照ください。
https://www.gmp-publishing.com/en/gmp-news/gmp-aktuell/pics-meeting-april-2018.html
※追記更新(2018.05.16)
5/9付でPIC/S本部から「PIC/S meetings in Geneva, Switzerland, 16-18 April 2018」と題して、本年4/16-4/18にジュネーブで開催
ハイライトは以下の通りです。
ちなみに、ガイド改訂版や新規aide-memoire等につい
・New PIC/S guidance on GMP inspection reliance based on draft by ICMRA with aim to maximise inspection resources for GMP compliance of overseas facilities.
・Revision of PIC/S GMP guide (PE009). Chapters 3, 5 and 8 of the PIC/S GMP guide have been revised with entry into force on 1 July 2018; along with adoption of transposition for pic/s purposes of EU guidances on GMP exicipent risk assessment, exposure limits and GDP for API.
・New PIC/S working group established with WHO to revise Annex 2 on biologicals and ATMP.
・Limited stakeholder consultation for draft PIC/S guidance on data integrity
・New PIC/S aide-memoire on cross-contamination in shared facilities.
・New PIC/S pre-accession application received from Pakistan / DRAP.
・New PIC/S working groups to be established on whistle-blowers/confidential informants; quality defects procedures; as well as PIC/S assessment and re-assessment procedures.
・PIC/S 2018 seminar to be hosted by US FDA in Chicago and other news in the field of training for GM(D)P inspectors.
また、PIC/S本部のPress Releaseに合せて、英国MHRA/Inspectorat
興味のある方は、下記URLsのPress Release並びにプログをご参照ください。
●PIC/S News「PIC/S meetings in Geneva, Switzerland, 16-18 April 2018」
https://www.picscheme.org/en/
●Press release「PIC/S Meetings in Geneva (Switzerland)」~pdfファイル
https://www.picscheme.org/
●5/9付英国MHRA/Inspectorate Blog「PIC/S press release following April 2018 meeting」
https://mhrainspectorate.blog.
【5/12付追記更新】
5/11付のRAPSが「PIC/S Adopts New Guidance on GMP Inspections」と題して記事に取り上げています。
興味のある方は、下記URLのニュース記事をご参照ください。
https://www.raps.org/news-and-
【5/16付追記更新】
5/14付のGMP Publishingが「PIC/S Meeting in April 2018」と題して記事に取り上げています。
興味のある方は、下記URLのニュース記事をご参照ください。
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