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𝗚𝗖𝗣 𝗦𝗻𝗶𝗽𝗽𝗲𝘁𝘀: 𝗖𝗼𝗽𝗶𝗲𝘀 𝗪𝗶𝘁𝗵𝗼𝘂𝘁 𝗢𝗿𝗶𝗴𝗶𝗻𝗮𝗹𝘀 📜📃 We continue sharing a few snippets from the new ICH GCP revision, dug up and commented by one of our regulatory experts, who has seen more guidelines and regulations in his professional life than we can count. 📚😮 Be assured that FGK has the experience, skills and understanding to guide you through the regulatory jungle!👌 Today’s GCP snippet is about the definition of “certified copies” according to ICH E6 (R3). Excerpt from the Article: “𝘐𝘊𝘏 𝘌6 (𝘙3) 𝘧𝘦𝘢𝘵𝘶𝘳𝘦𝘴 𝘢𝘯 𝘪𝘯𝘤𝘰𝘯𝘴𝘱𝘪𝘤𝘶𝘰𝘶𝘴, 𝘣𝘶𝘵 𝘵𝘳𝘰𝘶𝘣𝘭𝘦𝘴𝘰𝘮𝘦 𝘤𝘰𝘯𝘤𝘦𝘱𝘵 𝘤𝘢𝘭𝘭𝘦𝘥 “𝘤𝘦𝘳𝘵𝘪𝘧𝘪𝘦𝘥 𝘤𝘰𝘱𝘺”. 𝘛𝘩𝘦 𝘨𝘭𝘰𝘴𝘴𝘢𝘳𝘺 𝘥𝘦𝘧𝘪𝘯𝘦𝘴: 🆕 “𝘈 𝘤𝘰𝘱𝘺 (𝘪𝘳𝘳𝘦𝘴𝘱𝘦𝘤𝘵𝘪𝘷𝘦 𝘰𝘧 𝘵𝘩𝘦 𝘵𝘺𝘱𝘦 𝘰𝘧 𝘮𝘦𝘥𝘪𝘢 𝘶𝘴𝘦𝘥) 𝘰𝘧 𝘵𝘩𝘦 𝘰𝘳𝘪𝘨𝘪𝘯𝘢𝘭 𝘳𝘦𝘤𝘰𝘳𝘥 𝘵𝘩𝘢𝘵 𝘩𝘢𝘴 𝘣𝘦𝘦𝘯 𝘷𝘦𝘳𝘪𝘧𝘪𝘦𝘥 (𝘪.𝘦., 𝘣𝘺 𝘢 𝘥𝘢𝘵𝘦𝘥 𝘴𝘪𝘨𝘯𝘢𝘵𝘶𝘳𝘦 𝘰𝘳 𝘣𝘺 𝘨𝘦𝘯𝘦𝘳𝘢𝘵𝘪𝘰𝘯 𝘵𝘩𝘳𝘰𝘶𝘨𝘩 𝘢 𝘷𝘢𝘭𝘪𝘥𝘢𝘵𝘦𝘥 𝘱𝘳𝘰𝘤𝘦𝘴𝘴) 𝘵𝘰 𝘩𝘢𝘷𝘦 𝘵𝘩𝘦 𝘴𝘢𝘮𝘦 𝘪𝘯𝘧𝘰𝘳𝘮𝘢𝘵𝘪𝘰𝘯 𝘢𝘴 𝘵𝘩𝘦 𝘰𝘳𝘪𝘨𝘪𝘯𝘢𝘭, 𝘪𝘯𝘤𝘭𝘶𝘥𝘪𝘯𝘨 𝘳𝘦𝘭𝘦𝘷𝘢𝘯𝘵 𝘮𝘦𝘵𝘢𝘥𝘢𝘵𝘢, 𝘸𝘩𝘦𝘳𝘦 𝘢𝘱𝘱𝘭𝘪𝘤𝘢𝘣𝘭𝘦.” 𝘋𝘦𝘴𝘱𝘪𝘵𝘦 𝘴𝘰𝘶𝘯𝘥𝘪𝘯𝘨 𝘣𝘰𝘳𝘪𝘯𝘨, 𝘪𝘵 𝘨𝘢𝘪𝘯𝘴 𝘮𝘰𝘮𝘦𝘯𝘵𝘶𝘮 𝘪𝘯 𝘴𝘦𝘤𝘵𝘪𝘰𝘯 𝘊.2.9: 🆕 “𝘞𝘩𝘦𝘯 𝘢 𝘤𝘰𝘱𝘺 𝘪𝘴 𝘶𝘴𝘦𝘥 𝘵𝘰 𝘱𝘦𝘳𝘮𝘢𝘯𝘦𝘯𝘵𝘭𝘺 𝘳𝘦𝘱𝘭𝘢𝘤𝘦 𝘵𝘩𝘦 𝘰𝘳𝘪𝘨𝘪𝘯𝘢𝘭 𝘦𝘴𝘴𝘦𝘯𝘵𝘪𝘢𝘭 𝘳𝘦𝘤𝘰𝘳𝘥, 𝘵𝘩𝘦 𝘤𝘰𝘱𝘺 𝘴𝘩𝘰𝘶𝘭𝘥 𝘧𝘶𝘭𝘧𝘪𝘭 𝘵𝘩𝘦 𝘳𝘦𝘲𝘶𝘪𝘳𝘦𝘮𝘦𝘯𝘵𝘴 𝘧𝘰𝘳 𝘤𝘦𝘳𝘵𝘪𝘧𝘪𝘦𝘥 𝘤𝘰𝘱𝘪𝘦𝘴.” 𝘍𝘪𝘳𝘴𝘵, 𝘺𝘰𝘶 𝘮𝘪𝘨𝘩𝘵 𝘳𝘦𝘢𝘭𝘪𝘴𝘦 𝘵𝘩𝘢𝘵 𝘱𝘳𝘰𝘥𝘶𝘤𝘵𝘪𝘰𝘯 𝘰𝘧 𝘤𝘦𝘳𝘵𝘪𝘧𝘪𝘦𝘥 𝘤𝘰𝘱𝘪𝘦𝘴 𝘸𝘪𝘭𝘭 𝘣𝘦 𝘢 𝘵𝘪𝘮𝘦-𝘤𝘰𝘯𝘴𝘶𝘮𝘪𝘯𝘨 𝘵𝘢𝘴𝘬 𝘪𝘧 𝘺𝘰𝘶 𝘢𝘱𝘱𝘭𝘺 𝘪𝘵 𝘵𝘰 𝘦𝘷𝘦𝘳𝘺 𝘴𝘪𝘯𝘨𝘭𝘦 𝘦𝘴𝘴𝘦𝘯𝘵𝘪𝘢𝘭 𝘳𝘦𝘤𝘰𝘳𝘥 𝘪𝘯 𝘵𝘩𝘦 𝘛𝘳𝘪𝘢𝘭 𝘔𝘢𝘴𝘵𝘦𝘳 𝘍𝘪𝘭𝘦 𝘢𝘯𝘥 𝘐𝘯𝘷𝘦𝘴𝘵𝘪𝘨𝘢𝘵𝘰𝘳 𝘚𝘪𝘵𝘦 𝘍𝘪𝘭𝘦 - 𝘸𝘩𝘪𝘤𝘩 𝘺𝘰𝘶 𝘱𝘳𝘰𝘣𝘢𝘣𝘭𝘺 𝘩𝘢𝘷𝘦 𝘵𝘰 𝘥𝘰, 𝘥𝘦𝘴𝘱𝘪𝘵𝘦 𝘵𝘩𝘦 𝘭𝘪𝘱-𝘴𝘦𝘳𝘷𝘪𝘤𝘦 𝘵𝘩𝘢𝘵 𝘐𝘊𝘏 𝘌6 (𝘙3) 𝘱𝘢𝘺𝘴 (𝘪𝘯 𝘴𝘦𝘤𝘵𝘪𝘰𝘯 3.10 𝘢𝘯𝘥 𝘦𝘭𝘴𝘦𝘸𝘩𝘦𝘳𝘦) 𝘵𝘰 𝘵𝘩𝘦 “𝘱𝘳𝘰𝘱𝘰𝘳𝘵𝘪𝘰𝘯𝘢𝘵𝘦 𝘢𝘯𝘥 𝘳𝘪𝘴𝘬-𝘣𝘢𝘴𝘦𝘥 𝘢𝘱𝘱𝘳𝘰𝘢𝘤𝘩 𝘵𝘰 𝘲𝘶𝘢𝘭𝘪𝘵𝘺 𝘮𝘢𝘯𝘢𝘨𝘦𝘮𝘦𝘯𝘵”. (…)   𝗪𝗵𝗮𝘁 𝗱𝗼 𝘆𝗼𝘂 𝘁𝗵𝗶𝗻𝗸 𝗼𝗳 𝘁𝗵𝗶𝘀? 𝗗𝗼𝗲𝘀 𝘁𝗵𝗲 𝗱𝗲𝗳𝗶𝗻𝗶𝘁𝗶𝗼𝗻 𝗰𝗮𝗽𝘁𝘂𝗿𝗲 𝘁𝗵𝗲 𝘀𝗽𝗶𝗿𝗶𝘁 𝗼𝗳 𝘁𝗵𝗲 𝘁𝗶𝗺𝗲𝘀 𝗮𝗻𝗱 𝗽𝗿𝗼𝘃𝗶𝗱𝗲 𝗰𝗹𝗮𝗿𝗶𝘁𝘆? 𝗥𝗲𝗮𝗱 𝘁𝗵𝗲 𝗳𝘂𝗹𝗹 𝗮𝗿𝘁𝗶𝗰𝗹𝗲 𝗵𝗲𝗿𝗲 ⬇️

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𝗚𝗖𝗣 𝗦𝗻𝗶𝗽𝗽𝗲𝘁𝘀: 𝗜𝗻𝘃𝗲𝘀𝘁𝗶𝗴𝗮𝘁𝗼𝗿𝘀 𝗢𝘂𝘁 𝗼𝗳 𝗦𝗶𝘁𝗲 🩺 Today we look at the role of the INVESTIGATOR according to the new ICH GCP E6 (R3), dug up and commented by one of our regulatory experts, who has seen more guidelines and regulations in his professional life than we can count. 📚😮 Excerpt from the Article:  “𝘛𝘩𝘦 𝘯𝘦𝘸 𝘷𝘦𝘳𝘴𝘪𝘰𝘯 𝘰𝘧 𝘐𝘊𝘏 𝘎𝘊𝘗 𝘴𝘶𝘱𝘱𝘰𝘳𝘵𝘴 𝘵𝘩𝘦 𝘤𝘰𝘯𝘥𝘶𝘤𝘵 𝘰𝘧 𝘤𝘭𝘪𝘯𝘪𝘤𝘢𝘭 𝘵𝘳𝘪𝘢𝘭𝘴 𝘪𝘯 𝘸𝘢𝘺𝘴 𝘵𝘩𝘢𝘵 𝘤𝘰𝘯𝘷𝘦𝘺 𝘵𝘩𝘦 𝘨𝘭𝘰𝘴𝘴 𝘰𝘧 𝘮𝘰𝘥𝘦𝘳𝘯 𝘵𝘪𝘮𝘦𝘴. (...) 𝘐𝘯 𝘭𝘪𝘯𝘦 𝘸𝘪𝘵𝘩 𝘵𝘩𝘪𝘴, 𝘵𝘩𝘦 𝘪𝘯𝘷𝘦𝘴𝘵𝘪𝘨𝘢𝘵𝘰𝘳𝘴 𝘢𝘳𝘦 𝘳𝘦𝘭𝘦𝘢𝘴𝘦𝘥 𝘧𝘳𝘰𝘮 𝘵𝘩𝘦𝘪𝘳 𝘷𝘪𝘯𝘵𝘢𝘨𝘦 𝘴𝘵𝘶𝘥𝘺 𝘤𝘦𝘯𝘵𝘦𝘳𝘴: 𝘐𝘊𝘏 𝘌6 (𝘙2) 𝘥𝘦𝘧𝘪𝘯𝘦𝘥 “𝘐𝘯𝘷𝘦𝘴𝘵𝘪𝘨𝘢𝘵𝘰𝘳” 𝘢𝘴 “𝘈 𝘱𝘦𝘳𝘴𝘰𝘯 𝘳𝘦𝘴𝘱𝘰𝘯𝘴𝘪𝘣𝘭𝘦 𝘧𝘰𝘳 𝘵𝘩𝘦 𝘤𝘰𝘯𝘥𝘶𝘤𝘵 𝘰𝘧 𝘵𝘩𝘦 𝘤𝘭𝘪𝘯𝘪𝘤𝘢𝘭 𝘵𝘳𝘪𝘢𝘭 𝘢𝘵 𝘢 𝘵𝘳𝘪𝘢𝘭 𝘴𝘪𝘵𝘦”, 𝘣𝘶𝘵 𝘐𝘊𝘏 𝘌6 (𝘙3) 𝘳𝘦𝘧𝘶𝘳𝘣𝘪𝘴𝘩𝘦𝘴 𝘵𝘩𝘪𝘴 30 𝘺𝘦𝘢𝘳𝘴 𝘰𝘭𝘥 𝘤𝘰𝘯𝘤𝘦𝘱𝘵 𝘢𝘯𝘥 𝘱𝘳𝘦𝘴𝘦𝘯𝘵𝘴 𝘵𝘩𝘦 𝘪𝘯𝘷𝘦𝘴𝘵𝘪𝘨𝘢𝘵𝘰𝘳 𝘢𝘴   🆕“𝘈 𝘱𝘦𝘳𝘴𝘰𝘯 𝘳𝘦𝘴𝘱𝘰𝘯𝘴𝘪𝘣𝘭𝘦 𝘧𝘰𝘳 𝘵𝘩𝘦 𝘤𝘰𝘯𝘥𝘶𝘤𝘵 𝘰𝘧 𝘵𝘩𝘦 𝘤𝘭𝘪𝘯𝘪𝘤𝘢𝘭 𝘵𝘳𝘪𝘢𝘭, 𝘪𝘯𝘤𝘭𝘶𝘥𝘪𝘯𝘨 𝘵𝘩𝘦 𝘵𝘳𝘪𝘢𝘭 𝘱𝘢𝘳𝘵𝘪𝘤𝘪𝘱𝘢𝘯𝘵𝘴 𝘧𝘰𝘳 𝘸𝘩𝘰𝘮 𝘵𝘩𝘢𝘵 𝘱𝘦𝘳𝘴𝘰𝘯 𝘩𝘢𝘴 𝘳𝘦𝘴𝘱𝘰𝘯𝘴𝘪𝘣𝘪𝘭𝘪𝘵𝘺 𝘥𝘶𝘳𝘪𝘯𝘨 𝘵𝘩𝘦 𝘤𝘰𝘯𝘥𝘶𝘤𝘵 𝘰𝘧 𝘵𝘩𝘦 𝘵𝘳𝘪𝘢𝘭”. 𝘞𝘪𝘵𝘩 𝘵𝘩𝘦 𝘵𝘳𝘪𝘢𝘭 𝘴𝘪𝘵𝘦 𝘴𝘵𝘪𝘭𝘭 𝘱𝘳𝘦𝘴𝘦𝘯𝘵, 𝘐𝘊𝘏 𝘌6 (𝘙2) 𝘴𝘢𝘸 𝘪𝘵 𝘢𝘴 “𝘛𝘩𝘦 𝘭𝘰𝘤𝘢𝘵𝘪𝘰𝘯(𝘴) 𝘸𝘩𝘦𝘳𝘦 𝘵𝘳𝘪𝘢𝘭-𝘳𝘦𝘭𝘢𝘵𝘦𝘥 𝘢𝘤𝘵𝘪𝘷𝘪𝘵𝘪𝘦𝘴 𝘢𝘳𝘦 𝘢𝘤𝘵𝘶𝘢𝘭𝘭𝘺 𝘤𝘰𝘯𝘥𝘶𝘤𝘵𝘦𝘥”, 𝘸𝘩𝘪𝘭𝘦 𝘵𝘩𝘦 𝘯𝘦𝘸 𝘐𝘊𝘏 𝘌6 (𝘙3) 𝘥𝘦𝘴𝘤𝘳𝘪𝘣𝘦𝘴 𝘪𝘵 𝘢𝘴 🆕 “ 𝘛𝘩𝘦 𝘭𝘰𝘤𝘢𝘵𝘪𝘰𝘯(𝘴) 𝘸𝘩𝘦𝘳𝘦 𝘵𝘳𝘪𝘢𝘭-𝘳𝘦𝘭𝘢𝘵𝘦𝘥 𝘢𝘤𝘵𝘪𝘷𝘪𝘵𝘪𝘦𝘴 𝘢𝘳𝘦 𝘤𝘰𝘯𝘥𝘶𝘤𝘵𝘦𝘥 𝘢𝘯𝘥/𝘰𝘳 𝘤𝘰𝘰𝘳𝘥𝘪𝘯𝘢𝘵𝘦𝘥 𝘶𝘯𝘥𝘦𝘳 𝘵𝘩𝘦 𝘪𝘯𝘷𝘦𝘴𝘵𝘪𝘨𝘢𝘵𝘰𝘳’𝘴/𝘪𝘯𝘴𝘵𝘪𝘵𝘶𝘵𝘪𝘰𝘯’𝘴 𝘰𝘷𝘦𝘳𝘴𝘪𝘨𝘩𝘵”. (𝘞𝘦𝘭𝘭, 𝘵𝘰 𝘣𝘦 𝘢𝘤𝘤𝘶𝘳𝘢𝘵𝘦, 𝘐𝘊𝘏 𝘌6 (𝘙3) 𝘯𝘢𝘮𝘦𝘴 𝘵𝘩𝘪𝘴 𝘭𝘰𝘤𝘢𝘵𝘪𝘰𝘯 “𝘐𝘯𝘷𝘦𝘴𝘵𝘪𝘨𝘢𝘵𝘰𝘳 𝘚𝘪𝘵𝘦” 𝘸𝘩𝘪𝘭𝘦 𝘵𝘩𝘦 𝘰𝘭𝘥 𝘯𝘢𝘮𝘦 “𝘵𝘳𝘪𝘢𝘭 𝘴𝘪𝘵𝘦” 𝘢𝘱𝘱𝘦𝘢𝘳𝘴 𝘰𝘯𝘭𝘺 𝘰𝘯𝘤𝘦 𝘪𝘯 𝘴𝘦𝘤𝘵𝘪𝘰𝘯 3.16.1, 𝘸𝘩𝘦𝘳𝘦 𝘪𝘵 𝘱𝘳𝘰𝘣𝘢𝘣𝘭𝘺 𝘳𝘦𝘴𝘪𝘴𝘵𝘦𝘥 𝘤𝘰𝘯𝘴𝘰𝘭𝘪𝘥𝘢𝘵𝘪𝘰𝘯 𝘰𝘧 𝘵𝘩𝘦 𝘵𝘦𝘹𝘵.) 𝘛𝘩𝘦 𝘯𝘦𝘸 𝘥𝘦𝘧𝘪𝘯𝘪𝘵𝘪𝘰𝘯𝘴 – 𝘵𝘩𝘦𝘰𝘳𝘦𝘵𝘪𝘤𝘢𝘭𝘭𝘺 – 𝘸𝘰𝘶𝘭𝘥 𝘢𝘭𝘭𝘰𝘸 𝘪𝘯𝘷𝘦𝘴𝘵𝘪𝘨𝘢𝘵𝘰𝘳𝘴 𝘵𝘰 𝘯𝘦𝘷𝘦𝘳 𝘴𝘦𝘦 𝘱𝘢𝘳𝘵𝘪𝘤𝘪𝘱𝘢𝘯𝘵𝘴 𝘥𝘪𝘳𝘦𝘤𝘵𝘭𝘺 𝘢𝘯𝘥 𝘤𝘭𝘪𝘯𝘪𝘤𝘢𝘭 𝘵𝘳𝘪𝘢𝘭𝘴 𝘵𝘰 𝘣𝘦𝘤𝘰𝘮𝘦 𝘥𝘦𝘤𝘦𝘯𝘵𝘳𝘢𝘭𝘪𝘴𝘦𝘥 (…)” 𝗪𝗵𝗮𝘁 𝗱𝗼 𝘆𝗼𝘂 𝘁𝗵𝗶𝗻𝗸 𝗼𝗳 𝘁𝗵𝗲 𝗻𝗲𝘄 𝗮𝗽𝗽𝗿𝗼𝗮𝗰𝗵? 𝗗𝗼 𝘁𝗵𝗲𝘆 𝗰𝗮𝗽𝘁𝘂𝗿𝗲 𝘁𝗵𝗲 𝘀𝗽𝗶𝗿𝗶𝘁 𝗼𝗳 𝘁𝗵𝗲 𝘁𝗶𝗺𝗲𝘀 𝗮𝗻𝗱 𝗽𝗿𝗼𝘃𝗶𝗱𝗲 𝗰𝗹𝗮𝗿𝗶𝘁𝘆? Be assured that FGK has the experience, skills and understanding to guide you through the regulatory jungle!👌 #wefeelresponsible #clinicalresearch Read the full article here ⬇️

𝗚𝗖𝗣 𝗦𝗻𝗶𝗽𝗽𝗲𝘁𝘀: 𝗔 𝗧𝗿𝗲𝗮𝘁𝗶𝘀𝗲 𝗼𝗳 𝗘𝘀𝘀𝗲𝗻𝘁𝗶𝗮𝗹𝗶𝘁𝘆 𝗶𝗻 𝗧𝘄𝗼 𝗟𝗶𝘀𝘁𝘀 Struggling with the new ICH GCP E6 (R3)? You are not alone 😊 Be assured that FGK has the experience, skills and understanding to guide you through the regulatory jungle!👌 Nevertheless, we will be sharing a few snippets from the new revision, dug up and commented by one of our regulatory experts, who has seen more guidelines and regulations in his professional life than we can count. 📚😮   Today, he elaborates on the topic of “Essential Records”.   Excerpt from the Article: “𝘐𝘧 𝘺𝘰𝘶 𝘩𝘢𝘷𝘦 𝘸𝘰𝘳𝘬𝘦𝘥 𝘸𝘪𝘵𝘩 𝘐𝘊𝘏 𝘌6 𝘣𝘦𝘧𝘰𝘳𝘦, 𝘣𝘦 𝘢𝘸𝘢𝘳𝘦 𝘵𝘩𝘢𝘵 𝘪𝘯 𝘐𝘊𝘏 𝘌6 (𝘙3) 𝘵𝘩𝘦 𝘧𝘰𝘭𝘭𝘰𝘸𝘪𝘯𝘨 𝘥𝘦𝘧𝘪𝘯𝘪𝘵𝘪𝘰𝘯 𝘪𝘴 𝘨𝘰𝘯𝘦: “𝘌𝘴𝘴𝘦𝘯𝘵𝘪𝘢𝘭 𝘋𝘰𝘤𝘶𝘮𝘦𝘯𝘵𝘴 𝘢𝘳𝘦 𝘵𝘩𝘰𝘴𝘦 𝘥𝘰𝘤𝘶𝘮𝘦𝘯𝘵𝘴 𝘸𝘩𝘪𝘤𝘩 𝘪𝘯𝘥𝘪𝘷𝘪𝘥𝘶𝘢𝘭𝘭𝘺 𝘢𝘯𝘥 𝘤𝘰𝘭𝘭𝘦𝘤𝘵𝘪𝘷𝘦𝘭𝘺 𝘱𝘦𝘳𝘮𝘪𝘵 𝘦𝘷𝘢𝘭𝘶𝘢𝘵𝘪𝘰𝘯 𝘰𝘧 𝘵𝘩𝘦 𝘤𝘰𝘯𝘥𝘶𝘤𝘵 𝘰𝘧 𝘢 𝘵𝘳𝘪𝘢𝘭 𝘢𝘯𝘥 𝘵𝘩𝘦 𝘲𝘶𝘢𝘭𝘪𝘵𝘺 𝘰𝘧 𝘵𝘩𝘦 𝘥𝘢𝘵𝘢 𝘱𝘳𝘰𝘥𝘶𝘤𝘦𝘥.” 𝘐𝘊𝘏 𝘌6 (𝘙3) 𝘧𝘦𝘢𝘵𝘶𝘳𝘦𝘴 𝘵𝘩𝘦 𝘥𝘦𝘧𝘪𝘯𝘪𝘵𝘪𝘰𝘯 𝘪𝘯 𝘢 𝘮𝘰𝘥𝘪𝘧𝘪𝘦𝘥 𝘸𝘢𝘺, 𝘯𝘰𝘸 𝘢𝘴 𝘢 𝘤𝘭𝘢𝘪𝘮:   🆕“𝘛𝘩𝘦 𝘦𝘴𝘴𝘦𝘯𝘵𝘪𝘢𝘭 𝘳𝘦𝘤𝘰𝘳𝘥𝘴 𝘱𝘦𝘳𝘮𝘪𝘵 𝘢𝘯𝘥 𝘤𝘰𝘯𝘵𝘳𝘪𝘣𝘶𝘵𝘦 𝘵𝘰 𝘵𝘩𝘦 𝘦𝘷𝘢𝘭𝘶𝘢𝘵𝘪𝘰𝘯 𝘰𝘧 𝘵𝘩𝘦 𝘤𝘰𝘯𝘥𝘶𝘤𝘵 𝘰𝘧 𝘢 𝘵𝘳𝘪𝘢𝘭 […].”   𝘉𝘺 𝘣𝘦𝘪𝘯𝘨 𝘴𝘰 𝘣𝘳𝘰𝘢𝘥, 𝘵𝘩𝘦 𝙛𝙤𝙧𝙢𝙚𝙧 𝘥𝘦𝘧𝘪𝘯𝘪𝘵𝘪𝘰𝘯 𝘢𝘭𝘭𝘰𝘸𝘦𝘥 𝘢𝘯𝘺𝘰𝘯𝘦 𝘸𝘩𝘰 𝘮𝘢𝘬𝘦𝘴 𝘢 𝘭𝘪𝘷𝘪𝘯𝘨 𝘧𝘳𝘰𝘮 𝘧𝘪𝘭𝘦𝘴 𝘵𝘰 𝘪𝘯𝘤𝘳𝘦𝘢𝘴𝘦 𝘵𝘩𝘦 𝘢𝘮𝘰𝘶𝘯𝘵 𝘢𝘯𝘥 𝘵𝘺𝘱𝘦 𝘰𝘧 𝘳𝘦𝘲𝘶𝘪𝘳𝘦𝘥 𝘥𝘰𝘤𝘶𝘮𝘦𝘯𝘵𝘴 𝘥𝘦𝘭𝘪𝘣𝘦𝘳𝘢𝘵𝘦𝘭𝘺 𝘣𝘺 𝘢𝘳𝘨𝘶𝘪𝘯𝘨 𝘵𝘩𝘢𝘵 𝘵𝘩𝘦 𝘱𝘳𝘦𝘷𝘪𝘰𝘶𝘴 𝘷𝘦𝘳𝘴𝘪𝘰𝘯𝘴 𝘰𝘧 𝘐𝘊𝘏 𝘌6 𝘦𝘹𝘱𝘭𝘪𝘤𝘪𝘵𝘭𝘺 𝘴𝘵𝘢𝘵𝘦𝘥 𝘵𝘩𝘢𝘵 𝘴𝘦𝘤𝘵𝘪𝘰𝘯 8 𝘤𝘰𝘯𝘵𝘢𝘪𝘯𝘦𝘥 𝘫𝘶𝘴𝘵 𝘢 “𝘮𝘪𝘯𝘪𝘮𝘶𝘮 𝘭𝘪𝘴𝘵 𝘰𝘧 𝘦𝘴𝘴𝘦𝘯𝘵𝘪𝘢𝘭 𝘥𝘰𝘤𝘶𝘮𝘦𝘯𝘵𝘴”. (…) 𝘛𝘩𝘦 𝘯𝘦𝘸 𝘐𝘊𝘏 𝘌6 (𝘙3) 𝘈𝘯𝘯𝘦𝘹 1, 𝘈𝘱𝘱𝘦𝘯𝘥𝘪𝘹 𝘊 𝘵𝘳𝘪𝘦𝘴 𝘵𝘰 𝘭𝘪𝘮𝘪𝘵 𝘢𝘳𝘣𝘪𝘵𝘳𝘢𝘳𝘺 𝘦𝘹𝘱𝘢𝘯𝘴𝘪𝘰𝘯 𝘰𝘧 𝘦𝘴𝘴𝘦𝘯𝘵𝘪𝘢𝘭 𝘳𝘦𝘤𝘰𝘳𝘥𝘴 𝘣𝘺 𝘵𝘩𝘳𝘦𝘦 𝘮𝘦𝘢𝘴𝘶𝘳𝘦𝘴 (…)”   𝗪𝗵𝗮𝘁 𝗱𝗼 𝘆𝗼𝘂 𝘁𝗵𝗶𝗻𝗸 𝗼𝗳 𝘁𝗵𝗲 𝗻𝗲𝘄 𝗮𝗽𝗽𝗿𝗼𝗮𝗰𝗵? 𝗗𝗼 𝘁𝗵𝗲𝘆 𝗰𝗮𝗽𝘁𝘂𝗿𝗲 𝘁𝗵𝗲 𝘀𝗽𝗶𝗿𝗶𝘁 𝗼𝗳 𝘁𝗵𝗲 𝘁𝗶𝗺𝗲𝘀 𝗮𝗻𝗱 𝗽𝗿𝗼𝘃𝗶𝗱𝗲 𝗰𝗹𝗮𝗿𝗶𝘁𝘆?   Read the full article here ⬇️

𝗚𝗖𝗣 𝗦𝗻𝗶𝗽𝗽𝗲𝘁𝘀: 𝗔 𝗥𝗲𝘃𝗮𝗺𝗽𝗲𝗱 𝗜𝗖𝗛 𝗚𝗖𝗣 𝗘𝗻𝘁𝗲𝗿𝘀 𝗶𝘁𝘀 𝗙𝗼𝘂𝗿𝘁𝗵 𝗗𝗲𝗰𝗮𝗱𝗲 Are you also trying to correctly interpret the wording of the new ICH GCP E6(R3) guideline?😮🤯 Come with us on a journey through the depths of the GCP jungle in search of truths ... and puns 😉 Today we start with an overview of the changes which will be followed by various topics that our FGK regulatory expert (100% human, not AI!) will take apart and bring back together for you. Feel free to comment wherever you think different, we love a good discussion! #clinicalresearch #wefeelresponsible

𝗚𝗖𝗣 𝗦𝗻𝗶𝗽𝗽𝗲𝘁𝘀: 𝗔 𝗥𝗲𝘃𝗮𝗺𝗽𝗲𝗱 𝗜𝗖𝗛 𝗚𝗖𝗣 𝗘𝗻𝘁𝗲𝗿𝘀 𝗶𝘁𝘀 𝗙𝗼𝘂𝗿𝘁𝗵 𝗗𝗲𝗰𝗮𝗱𝗲 Are you also trying to correctly interpret the wording of the new ICH GCP E6(R3) guideline?😮🤯 Come with us on a journey through the depths of the GCP jungle in search of truths ... and puns 😉 Today we start with an overview of the changes which will be followed by various topics that our FGK regulatory expert (100% human, not AI!) will take apart and bring back together for you. Feel free to comment wherever you think different, we love a good discussion! #clinicalresearch #wefeelresponsible

🎉 As we kicked off this year's conference season last week, we looked back for a moment at last year's memorable events: It's been a fantastic journey filled with laughter, new friendships, and strengthened partnerships. Here’s a short throwback to celebrate all the incredible moments we shared. 🤝💼 🙌 A huge thank you to everyone who made the 2024 event season so special! We are excited and hopeful for another year of equally fun, interesting, and heartwarming events. Let's rock 2025! 🌟 #wefeelresponsible #clinicalresearch

Meanwhile in Brussels... Martin Krauss talking about the new EUCROF GDPR Code of Conduct for service providers at MyData-TRUST - Data Protection & Privacy for Life Sciences' EU Data Privacy for Health Summit, together with Victoria Watts and Yoani Matsakis. These events are a such great opportunity for our industry to keep up to date with Data Protection in the life science industry and remind ourselves that the trust of patients in clinical trials is one of the pillars for advancing medicine! Thanks, MDT💙 #wefeelresponsible #clinicalresearch (side note: our selfie clearly shows that Martin is not capable of proper photo composition🫣...for those who are still reading:it's the famous TinTin rocket to the moon in the background)

To all Medical Device companies out there: Shout Out Loud! 📣 Don’t skip the chance on taking part at the European Commission’s survey on the practicability of the European MDR and IVD regulations until March 21: Since mid-December 2024, YOU can provide input on Regulation 2017/745 on medical devices and Regulation 2017/746 on in-vitro diagnostics. The results will later be incorporated into the overall evaluation, feedback will be published on an ongoing basis.   Participation is possible here: Link in comment below ⬇️

🌍 Looking for a legal representative for conducting clinical trials in Europe? 🔍 Are you planning a clinical study in the EU, Switzerland, or the UK? At FGK Representative Service, we specialize in regulatory compliance with Clinical Trial Regulation (CTR), Medical Device Regulation (MDR), and Orphan Drug Designation (ODD). Our experienced team provides competent, and cost- and time-efficient sponsor representation for non-EU sponsors. 📅 Book your free consultation today: https://lnkd.in/eVcW679J #wefeelresponsible