Hei,

Kliinisten lääketutkimusten EU-asetuksen (536/2014) mukainen siirtymäaika päättyy uusien hakemusten osalta. 31.1.2023 alkaen kaikki uudet kliiniset lääketutkimukset tulee toimittaa viranomaisten arvioitaviksi Euroopan lääkeviraston (EMA) CTIS-järjestelmän (Clinical Trials Regulation) kautta.

EMA järjestää asiasta avoimen info-tilaisuuden pe 20.1.2023 klo 11-14 (Suomen aikaa). Lisätietoa alla olevassa viestissä.

Tiedon välitti, Katja Riipinen

Katja Riipinen Tutkimuskoordinaattori Oulun yliopistollinen sairaalahttps://oys.fi/ Pohjois-Pohjanmaan hyvinvointialue Tutkimuspalvelut, N5 133 Puh. 08 315 4680, 050 448 4955

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Aihe: Virtual Public CTIS Event on 20 January 2023: Readiness for mandatory use of the Clinical Trials Regulation from 31 January 2023.

Dear CTIS Member States' representatives,

We would like to inform you that on Friday, 20 January 2023 from 10:00-13:00 CET we are holding a virtual public CTIS event "CTIS Event on Readiness for mandatory use of the Clinical Trials Regulation from 31 January 2023". The event agenda and further information are available on our website - linkhttps://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fevents%2Fclinical-trials-information-system-ctis-readiness-mandatory-use-clinical-trials-regulation-31&data=05%7C01%7CRiipinkt%40ppshp.mail.onmicrosoft.com%7Ce829af92c62b4a4cc23308daf39f1aa8%7C9837ed87b3784f49a0d1fb48e67da013%7C0%7C0%7C638090161915247928%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=9I9zAaHHrJAc%2BsrB%2FL%2BnrvYOzqkPCSoL3bGcEQRsg98%3D&reserved=0.

Stakeholders have been invited to raise questions in advance of the event until 16 January 2023, via the interaction tool Slido. Please go to www.sli.dohttps://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.sli.do%2F&data=05%7C01%7CRiipinkt%40ppshp.mail.onmicrosoft.com%7Ce829af92c62b4a4cc23308daf39f1aa8%7C9837ed87b3784f49a0d1fb48e67da013%7C0%7C0%7C638090161915247928%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=in8Ddv7XYRI9mZYEfzEPuagF3mVNwB8ZahfSJQP7zc4%3D&reserved=0 and enter the event code "CTIS2023".

Should you have any questions, please do not hesitate to contact us. Kind regards, Marianne

Marianne Wood Programme Support Officer Clinical Trials Information System (CTIS) Programme Data Analytics and Methods Task Force

Telephone +31 (0)88 781 8550 marianne.wood@ema.europa.eumailto:marianne.wood@ema.europa.eu | www.ema.europa.euhttps://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.ema.europa.eu%2F&data=05%7C01%7CRiipinkt%40ppshp.mail.onmicrosoft.com%7Ce829af92c62b4a4cc23308daf39f1aa8%7C9837ed87b3784f49a0d1fb48e67da013%7C0%7C0%7C638090161915247928%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=3xsX00harGnxv63awPQ4SaXPJdmF8RVGuAkuBkIaZvY%3D&reserved=0

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