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Helmut ★★★   Vienna, Austria, 2024-04-19 17:40 (236 d 13:29 ago) Posting: # 23959 Views: 2,617 |
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Dear all, as a birthday gift the EMA published aConsultation is open until 30 October 2024. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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Chirag ☆ India, 2024-04-22 06:37 (234 d 00:32 ago) (edited on 2024-04-22 06:48) @ Helmut Posting: # 23960 Views: 2,073 |
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Dear Helmut, Thank you for sharing. Upon reading, I noticed that the recently introduced guidelines still relate to Directive 2001/20/EC rather than 536/2014. To the best of my knowledge, the revised guideline is effective from January 31, 2023. Trials that were authorized under the Clinical Trials Directive may be extended until January 31, 2025. If they are not finished by then, they will likewise be governed by the Clinical Trials Regulation and need to be registered in CTIS. I would like everyone to help me with this. Since this is my first post, I apologize for any errors. Regards, Chirag |
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Ohlbe ★★★ France, 2024-04-22 16:07 (233 d 15:02 ago) @ Chirag Posting: # 23961 Views: 2,042 |
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Dear Chirag, ❝ Since this is my first post, I apologize for any errors. No error, and welcome to the forum. ❝ Upon reading, I noticed that the recently introduced guidelines still relate to Directive 2001/20/EC rather than 536/2014. You're absolutely right, the guideline should refer to the Clinical Trial Regulation and no longer to the Clinical Trial Directive. There was a first public consultation to revise this guideline in 2017 (before the CTR came into force), and it looks like they failed to update this paragraph after that. The document just published is again a draft for public consultation. Hopefully this will be pointed out and corrected. — Regards Ohlbe |
Ing. Helmut Schütz