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 sairaala
Pohjois-Pohjanmaan hyvinvointialue
Tutkimuspalvelut, N5 133
Puh. 08 315 4680, 050 448 4955
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 – link.
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.do 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.eu |
www.ema.europa.eu
Official address Domenico Scarlattilaan 6 | 1083 HS Amsterdam | The Netherlands
Address for visits and deliveries Refer to
How to find us
This message and any attachment contain information which may be confidential or otherwise protected
from disclosure. It is intended for the addressee(s) only and should not be relied upon as legal advice unless it is otherwise stated. If you are not the intended recipient(s) (or authorised by an addressee who received this message), access to this e-mail,
or any disclosure or copying of its contents, or any action taken (or not taken) in reliance on it is unauthorised and may be unlawful. If you have received this e-mail in error, please inform the sender immediately.
