{"id":1264,"date":"2017-02-03T08:03:00","date_gmt":"2017-02-03T08:03:00","guid":{"rendered":"https:\/\/pepharm.gr\/consultation-on-a-reflection-paper-issued-by-ema-3rs\/"},"modified":"2021-11-29T11:50:29","modified_gmt":"2021-11-29T11:50:29","slug":"consultation-on-a-reflection-paper-issued-by-ema-3rs","status":"publish","type":"post","link":"https:\/\/pepharm.gr\/en\/consultation-on-a-reflection-paper-issued-by-ema-3rs\/","title":{"rendered":"Consultation on a reflection paper issued by EMA (3Rs)"},"content":{"rendered":"
\n
\n
<\/div>\n

\u03a4\u03bf \u03c0\u03b1\u03c1\u03b1\u03ba\u03ac\u03c4\u03c9 \u03ad\u03b3\u03b3\u03c1\u03b1\u03c6\u03bf \u03c0\u03b5\u03c1\u03b9\u03bb\u03b1\u03bc\u03b2\u03ac\u03bd\u03b5\u03b9 \u03b8\u03b5\u03bc\u03b1\u03c4\u03bf\u03bb\u03bf\u03b3\u03af\u03b1 \u03c0\u03bf\u03c5 \u03b1\u03c6\u03bf\u03c1\u03ac \u03c3\u03b5 \u03b5\u03c0\u03b1\u03b3\u03b3\u03b5\u03bb\u03bc\u03b1\u03c4\u03af\u03b5\u03c2 \u03b1\u03c0\u03cc \u03c4\u03b1 \u03c4\u03bc\u03ae\u03bc\u03b1\u03c4\u03b1 Regulatory affairs, \u03a0\u03b1\u03c1\u03b1\u03b3\u03c9\u03b3\u03ae\u03c2, \u0394\u03b9\u03b1\u03c3\u03c6\u03ac\u03bb\u03b9\u03c3\u03b7\u03c2 \u03c0\u03bf\u03b9\u03cc\u03c4\u03b7\u03c4\u03b1\u03c2 \u03ba\u03b1\u03b8\u03ce\u03c2 \u03b5\u03c0\u03af\u03c3\u03b7\u03c2 \u03ba\u03b1\u03b9 \u03c3\u03b5 \u03b5\u03c0\u03b9\u03c3\u03c4\u03b7\u03bc\u03bf\u03bd\u03b9\u03ba\u03cc \u03c0\u03c1\u03bf\u03c3\u03c9\u03c0\u03b9\u03ba\u03cc \u0399\u03b1\u03c4\u03c1\u03b9\u03ba\u03ce\u03bd \u03c4\u03bc\u03b7\u03bc\u03ac\u03c4\u03c9\u03bd \u03bc\u03b5 \u03b3\u03bd\u03ce\u03c3\u03b5\u03b9\u03c2 \u03c6\u03b1\u03c1\u03bc\u03b1\u03ba\u03bf\u03bb\u03bf\u03b3\u03af\u03b1\u03c2, \u03c4\u03bf\u03be\u03b9\u03ba\u03bf\u03bb\u03bf\u03b3\u03af\u03b1\u03c2 \u03ba\u03b1\u03b9 \u03c6\u03b1\u03c1\u03bc\u03b1\u03ba\u03bf\u03ba\u03b9\u03bd\u03b7\u03c4\u03b9\u03ba\u03ae\u03c2.<\/p><\/div>\n

<\/div>\n
\u03a0\u03b1\u03c1\u03b1\u03ba\u03b1\u03bb\u03bf\u03cd\u03bc\u03b5 \u03cc\u03c0\u03c9\u03c2 \u03b1\u03c0\u03bf\u03c3\u03c4\u03b5\u03af\u03bb\u03b5\u03c4\u03b5 \u03c4\u03b1 \u03c3\u03c7\u03cc\u03bb\u03b9\u03b1 \u03c3\u03b1\u03c2<\/a> \u03bc\u03ad\u03c7\u03c1\u03b9 \u03c4\u03b9\u03c2 30 \u0391\u03c0\u03c1\u03b9\u03bb\u03af\u03bf\u03c5 2017 \u03c0\u03c1\u03bf\u03ba\u03b5\u03b9\u03bc\u03ad\u03bd\u03bf\u03c5 \u03b7 \u03bf\u03bc\u03ac\u03b4\u03b1 \u03b5\u03c1\u03b3\u03b1\u03c3\u03af\u03b1\u03c2 Regulatory Affairs \u03ba\u03b1\u03b9 \u0392\u03b9\u03bf\u03bc\u03b7\u03c7\u03b1\u03bd\u03af\u03b1\u03c2 \u03c4\u03b7\u03c2 \u03a0\u0395\u03a6 \u03c3\u03b5 \u03c3\u03c5\u03bd\u03b5\u03c1\u03b3\u03b1\u03c3\u03af\u03b1 \u03bc\u03b5 \u03c4\u03bf \u03c4\u03bc\u03ae\u03bc\u03b1 Technical and Professional Development \u03c4\u03b7\u03c2 EIPG \u03bd\u03b1 \u03b1\u03c0\u03bf\u03c3\u03c4\u03b5\u03af\u03bb\u03bf\u03c5\u03bd \u03c3\u03c5\u03b3\u03ba\u03b5\u03bd\u03c4\u03c1\u03c9\u03c4\u03b9\u03ba\u03ae \u03c6\u03cc\u03c1\u03bc\u03b1 \u03c0\u03c1\u03bf\u03c2 \u03c4\u03bf\u03bd \u0395\u039c\u0391, \u03bc\u03b5 \u03c3\u03c7\u03cc\u03bb\u03b9\u03b1 \u03b3\u03b9\u03b1 \u03c4\u03b7\u03bd \u03c4\u03b5\u03bb\u03b9\u03ba\u03ae \u03b4\u03b9\u03b1\u03bc\u03cc\u03c1\u03c6\u03c9\u03c3\u03b7 \u03c4\u03bf\u03c5 \u03b5\u03b3\u03b3\u03c1\u03ac\u03c6\u03bf\u03c5. \u03a0\u03b1\u03c1\u03b1\u03ba\u03b1\u03bb\u03b5\u03af\u03c3\u03c4\u03b5 \u03cc\u03c0\u03c9\u03c2 \u03c5\u03c0\u03bf\u03b4\u03b5\u03af\u03be\u03b5\u03c4\u03b5 \u03b1\u03bd \u03c4\u03b1 \u03c3\u03c7\u03cc\u03bb\u03b9\u03b1 \u03c3\u03b1\u03c2 \u03b5\u03af\u03bd\u03b1\u03b9 \u03b3\u03b5\u03bd\u03b9\u03ba\u03ac \u03ae \u03b1\u03c6\u03bf\u03c1\u03bf\u03cd\u03bd \u03c3\u03b5 \u03b5\u03b9\u03b4\u03b9\u03ba\u03ac \u03b8\u03ad\u03bc\u03b1\u03c4\u03b1 \u03ba\u03b1\u03b9 \u03c3\u03b5 \u03c0\u03bf\u03b9\u03b1 \u03c3\u03b5\u03bb\u03af\u03b4\u03b1 \u03c4\u03bf\u03c5 \u03b5\u03b3\u03b3\u03c1\u03ac\u03c6\u03bf\u03c5 \u03b1\u03bd\u03b1\u03c6\u03ad\u03c1\u03bf\u03bd\u03c4\u03b1\u03b9.<\/div>\n

<\/p>\n

Reflection paper providing an overview of the current regulatory testing requirements for medicinal products for human use and opportunities for implementation of the 3Rs.<\/b><\/a><\/div>\n
<\/div>\n
The current reflection paper provides a snapshot of the testing requirements at the time of publication. It is to be expected that, over time, new testing approaches will become accepted and the tables will become out of date. In reviewing these tables the reader should remember that the fundamental responsibility of the CHMP is to ensure the quality, safety and efficacy of medicinal products and so to safeguard patient health. While the CHMP is committed to encouraging use of 3Rs approaches wherever possible, these cannot be accepted at the expense of safety and efficacy for patients.<\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"

\u03a4\u03bf \u03c0\u03b1\u03c1\u03b1\u03ba\u03ac\u03c4\u03c9 \u03ad\u03b3\u03b3\u03c1\u03b1\u03c6\u03bf \u03c0\u03b5\u03c1\u03b9\u03bb\u03b1\u03bc\u03b2\u03ac\u03bd\u03b5\u03b9 \u03b8\u03b5\u03bc\u03b1\u03c4\u03bf\u03bb\u03bf\u03b3\u03af\u03b1 \u03c0\u03bf\u03c5 \u03b1\u03c6\u03bf\u03c1\u03ac \u03c3\u03b5 \u03b5\u03c0\u03b1\u03b3\u03b3\u03b5\u03bb\u03bc\u03b1\u03c4\u03af\u03b5\u03c2 \u03b1\u03c0\u03cc \u03c4\u03b1 \u03c4\u03bc\u03ae\u03bc\u03b1\u03c4\u03b1 Regulatory affairs, \u03a0\u03b1\u03c1\u03b1\u03b3\u03c9\u03b3\u03ae\u03c2, \u0394\u03b9\u03b1\u03c3\u03c6\u03ac\u03bb\u03b9\u03c3\u03b7\u03c2 \u03c0\u03bf\u03b9\u03cc\u03c4\u03b7\u03c4\u03b1\u03c2 \u03ba\u03b1\u03b8\u03ce\u03c2 \u03b5\u03c0\u03af\u03c3\u03b7\u03c2 \u03ba\u03b1\u03b9 \u03c3\u03b5 \u03b5\u03c0\u03b9\u03c3\u03c4\u03b7\u03bc\u03bf\u03bd\u03b9\u03ba\u03cc \u03c0\u03c1\u03bf\u03c3\u03c9\u03c0\u03b9\u03ba\u03cc \u0399\u03b1\u03c4\u03c1\u03b9\u03ba\u03ce\u03bd \u03c4\u03bc\u03b7\u03bc\u03ac\u03c4\u03c9\u03bd \u03bc\u03b5 \u03b3\u03bd\u03ce\u03c3\u03b5\u03b9\u03c2 \u03c6\u03b1\u03c1\u03bc\u03b1\u03ba\u03bf\u03bb\u03bf\u03b3\u03af\u03b1\u03c2, \u03c4\u03bf\u03be\u03b9\u03ba\u03bf\u03bb\u03bf\u03b3\u03af\u03b1\u03c2 \u03ba\u03b1\u03b9 \u03c6\u03b1\u03c1\u03bc\u03b1\u03ba\u03bf\u03ba\u03b9\u03bd\u03b7\u03c4\u03b9\u03ba\u03ae\u03c2. \u03a0\u03b1\u03c1\u03b1\u03ba\u03b1\u03bb\u03bf\u03cd\u03bc\u03b5 \u03cc\u03c0\u03c9\u03c2 \u03b1\u03c0\u03bf\u03c3\u03c4\u03b5\u03af\u03bb\u03b5\u03c4\u03b5 \u03c4\u03b1 \u03c3\u03c7\u03cc\u03bb\u03b9\u03b1 \u03c3\u03b1\u03c2 \u03bc\u03ad\u03c7\u03c1\u03b9 \u03c4\u03b9\u03c2 30 \u0391\u03c0\u03c1\u03b9\u03bb\u03af\u03bf\u03c5 2017 \u03c0\u03c1\u03bf\u03ba\u03b5\u03b9\u03bc\u03ad\u03bd\u03bf\u03c5 \u03b7 \u03bf\u03bc\u03ac\u03b4\u03b1 \u03b5\u03c1\u03b3\u03b1\u03c3\u03af\u03b1\u03c2 Regulatory Affairs \u03ba\u03b1\u03b9 \u0392\u03b9\u03bf\u03bc\u03b7\u03c7\u03b1\u03bd\u03af\u03b1\u03c2 \u03c4\u03b7\u03c2 \u03a0\u0395\u03a6 \u03c3\u03b5 \u03c3\u03c5\u03bd\u03b5\u03c1\u03b3\u03b1\u03c3\u03af\u03b1 \u03bc\u03b5 […]<\/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":[1,168],"tags":[],"class_list":["post-1264","post","type-post","status-publish","format-standard","hentry","category-uncategorized","category-168","pmpro-has-access"],"acf":[],"_links":{"self":[{"href":"https:\/\/pepharm.gr\/en\/wp-json\/wp\/v2\/posts\/1264","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=1264"}],"version-history":[{"count":1,"href":"https:\/\/pepharm.gr\/en\/wp-json\/wp\/v2\/posts\/1264\/revisions"}],"predecessor-version":[{"id":2094,"href":"https:\/\/pepharm.gr\/en\/wp-json\/wp\/v2\/posts\/1264\/revisions\/2094"}],"wp:attachment":[{"href":"https:\/\/pepharm.gr\/en\/wp-json\/wp\/v2\/media?parent=1264"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pepharm.gr\/en\/wp-json\/wp\/v2\/categories?post=1264"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pepharm.gr\/en\/wp-json\/wp\/v2\/tags?post=1264"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}