EMA/Coronavirus (COVID-19) 関連情報(2020年6月10日付)
※追記更新(2020.06.17)
EMAからの6/10付でのCOVID-19関連情報です。
ただ、GMP Platform読者に関係しそうなものだけを取り上げていますことをご容赦ください。
また、必要に応じては、ECからの通知等も含めておりますことも、合せてご容赦ください。
関係者および興味のある方は、下記URLsのウェブサイト等をご参照ください。
l6/9付News release「Latest data support continued use of ACE inhibitors and ARB medicines during COVID-19 pandemic」
https://www.ema.europa.eu/en/news/latest-data-support-continued-use-ace-inhibitors-arb-medicines-during-covid-19-pandemic
[上記関連ニュース記事]
l6/10付RAPS「EMA affirms ACE inhibitors, ARBs safe during COVID-19」
https://www.raps.org/news-and-articles/news-articles/2020/6/ema-affirms-ace-inhibitors-arbs-safe-during-covid
l6/10付ガイダンス「Guidance on remote GCP inspections during the COVID-19 pandemic」
https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidance-remote-gcp-inspections-during-covid-19-pandemic_en.pdf
l6/10付Updated「Good clinincal practice (GCP) inspection procedures」
https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-clinical-practice/good-clinincal-practice-gcp-inspection-procedures
[上記関連ニュース記事]
l6/10付RAPS「EMA issues guidance on remote GCP inspections」
https://www.raps.org/news-and-articles/news-articles/2020/6/ema-issues-guidance-on-remote-gcp-inspections
[6/17付追記更新:上記関連ニュース記事]
l6/16付ECA/GMP News「Remote GCP Inspections」
https://www.gmp-compliance.org/gmp-news/remote-gcp-inspections
l6/10付Updated「COVID-19: What's new」
https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/covid-19-whats-new
l6/10付Updated「Treatments and vaccines for COVID-19」
https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines-covid-19
l6/10付EC「Mandate - A new framework for the organisation of health and social care following the COVID-19 pandemic」
https://ec.europa.eu/health/sites/health/files/expert_panel/docs/mandate_careorganisation_en.pdf
l6/9付EC「Summary report - 23rd Health Security Committee on COVID-19 outbreak」
https://ec.europa.eu/health/sites/health/files/preparedness_response/docs/ev_20200603_sr_en.pdf
l6/9付EC「Presentations - Webinar on the impact of COVID 19 for people living with a Rare Disease (9 June 2020)」
https://ec.europa.eu/health/ern/events/ev_20200609_en
EMAからの6/10付でのCOVID-19関連情報です。
ただ、GMP Platform読者に関係しそうなものだけを取り上げています
また、必要に応じては、ECからの通知等も含めておりますことも
関係者および興味のある方は、下記URLsのウェブサイト等をご
l6/9付News release「Latest data support continued use of ACE inhibitors and ARB medicines during COVID-19 pandemic」
https://www.ema.europa.eu/en/
[上記関連ニュース記事]
l6/10付RAPS「EMA affirms ACE inhibitors, ARBs safe during COVID-19」
https://www.raps.org/news-and-
l6/10付ガイダンス「Guidance on remote GCP inspections during the COVID-19 pandemic」
https://www.ema.europa.eu/en/
l6/10付Updated「Good clinincal practice (GCP) inspection procedures」
https://www.ema.europa.eu/en/
[上記関連ニュース記事]
l6/10付RAPS「EMA issues guidance on remote GCP inspections」
https://www.raps.org/news-and-
[6/17付追記更新:上記関連ニュース記事]
l6/16付ECA/GMP News「Remote GCP Inspections」
https://www.gmp-compliance.
l6/10付Updated「COVID-19: What's new」
https://www.ema.europa.eu/en/
l6/10付Updated「Treatments and vaccines for COVID-19」
https://www.ema.europa.eu/en/
l6/10付EC「Mandate - A new framework for the organisation of health and social care following the COVID-19 pandemic」
https://ec.europa.eu/health/
l6/9付EC「Summary report - 23rd Health Security Committee on COVID-19 outbreak」
https://ec.europa.eu/health/
l6/9付EC「Presentations - Webinar on the impact of COVID 19 for people living with a Rare Disease (9 June 2020)」
https://ec.europa.eu/health/
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