{"id":1302,"date":"2016-03-22T11:15:00","date_gmt":"2016-03-22T11:15:00","guid":{"rendered":"https:\/\/pepharm.gr\/ema-consulation-draft-guideline-on-gvp-and-draft-guidance-on-format-of-the-rmp\/"},"modified":"2016-03-22T11:15:00","modified_gmt":"2016-03-22T11:15:00","slug":"ema-consulation-draft-guideline-on-gvp-and-draft-guidance-on-format-of-the-rmp","status":"publish","type":"post","link":"https:\/\/pepharm.gr\/en\/ema-consulation-draft-guideline-on-gvp-and-draft-guidance-on-format-of-the-rmp\/","title":{"rendered":"EMA consulation: Draft guideline on GVP – and Draft guidance on format of the RMP"},"content":{"rendered":"
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The European Medicines Agency has released for public consultation a draft guideline on good pharmacovigilance practices (GVP) 3 – Module V \u2013 Risk management systems (Rev 2) and a draft guidance on format of the risk management plan (RMP) in the EU \u2013 in integrated format.<\/p>\n

Good pharmacovigilance practices (GVP) module V, released in 2012, advises developers of medicines, marketing authorisation holders and regulators on the design of effective risk management systems and plans. This draft guideline on good pharmacovigilance practices (GVP) 3 – Module V \u2013 Risk management systems (Rev 2) is the first major revision clarifyings the activities a risk management plan should focus on during the life cycle of a product. This will help to ensure that a risk-proportionate planning of activities directs resources to areas where the need for additional information and risk minimisation is greatest.<\/p>\n

The document open for consultation is available by clicking here<\/a>.<\/div>\n

<\/a>The European Medicines Agency is consulting stakeholders, through the draft guidance on format of the risk management plan (RMP) in the EU \u2013 in integrated format, on an amended risk management plan (RMP) template, to be used by medicine developers. The revision of the template is based on the principles described in the updated good pharmacovigilance practices (GVP) module V in the view of getting a focused risk management system and simplifying the way information is submitted to the regulators.<\/p>\n

The document open for consultation is available by clicking here<\/a>.<\/div>\n

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The European Medicines Agency has released for public consultation a draft guideline on good pharmacovigilance practices (GVP) 3 – Module V \u2013 Risk management systems (Rev 2) and a draft guidance on format of the risk management plan (RMP) in the EU \u2013 in integrated format. Good pharmacovigilance practices (GVP) module V, released in 2012, […]<\/p>","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"pmpro_default_level":"","footnotes":""},"categories":[54],"tags":[],"class_list":["post-1302","post","type-post","status-publish","format-standard","hentry","category-54","pmpro-has-access"],"acf":[],"_links":{"self":[{"href":"https:\/\/pepharm.gr\/en\/wp-json\/wp\/v2\/posts\/1302","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pepharm.gr\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/pepharm.gr\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/pepharm.gr\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/pepharm.gr\/en\/wp-json\/wp\/v2\/comments?post=1302"}],"version-history":[{"count":0,"href":"https:\/\/pepharm.gr\/en\/wp-json\/wp\/v2\/posts\/1302\/revisions"}],"wp:attachment":[{"href":"https:\/\/pepharm.gr\/en\/wp-json\/wp\/v2\/media?parent=1302"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pepharm.gr\/en\/wp-json\/wp\/v2\/categories?post=1302"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pepharm.gr\/en\/wp-json\/wp\/v2\/tags?post=1302"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}