Kliinilise uuringu otsus nr RKU-4/70

Barbara Ruepp ETOP IBCSG Partners Foundation Effingerstrasse 33 16.09.2024 nr RKU-4/70 3008 Bern ŠVEITS OTSUS Ravimi kliinilise uuringu loa andmiseks Euroopa Parlamendi ja nõukogu määruse (EL) nr 536/2014 (määrus (EL) 536/2014) alusel Uuringu sponsor ETOP IBCSG Partners Foundation esitas 21.05.2024 Ravimiametile taotluse ravimi kliinilise uuringu teostamiseks määruse (EL) 536/2014 artikli 5 (1) ja ravimiseaduse (RavS) § 991 lõikes 1 sätestatud tingimustel. Tuginedes määruse (EL) 536/2014 artiklile 8, hindamisaruande I ja II osaga hõlmatud aspekte hinnates, otsustab Ravimiamet ravimiseaduse § 996 lg 1 punkti 2 ja lõike 3 alusel anda uuringu sponsorile ETOP IBCSG Partners Foundation loa ravimi kliinilise uuringu läbiviimiseks vastavalt esitatud uuringuplaanile nr ETOP25-23 ADOPT-lung järgmistel tingimustel: uuringuplaani number: ETOP25-23 ADOPT-lung (versioon 1.1 kuupäevaga 15. august 2024) uuringu referentsnumber: 24-013 uuringu nimetus: „ETOP 25-23 ADOPT-lung: An international, multicentre, open-label randomised phase III trial to evaluate the benefit of adding adjuvant durvalumab after neoadjuvant chemotherapy plus durvalumab in patients with stage IIB-IIIB (N2) resectable NSCLC“ uuringu sponsor: ETOP IBCSG Partners Foundation uuritavate arv Eestis: 30 uuringu algus: oktoober 2024 vastutavad uurijad ja uuringukeskused: - Dr Kersti Oselin, sihtasutus Põhja-Eesti Regionaalhaigla, J. Sütiste tee 19, 13419 Tallinn, Eesti Nooruse 1 / 50411 Tartu / 737 4140 / [email protected] / www.ravimiamet.ee / Registrikood 70003477 Vaide käesolevale otsusele saab esitada Ravimiametile 30 päeva jooksul arvates otsuse teatavaks tegemisest vastavalt haldusmenetluse seaduse § 71 lõikele 1. Kui otsuse saaja soovib otsust vaidlustada halduskohtus, võib ta vastavalt halduskohtumenetluse seadustiku § 7 lõikele 1 ja § 46 lõikele 1 esitada kaebuse otsuse peale Tartu Halduskohtule 30 päeva jooksul otsuse teatavaks tegemisest arvates. Lugupidamisega (allkirjastatud digitaalselt) Katrin Kiisk Peadirektor 2 (2)  Barbara Ruepp ETOP IBCSG Partners Foundation Effingerstrasse 33 16.09.2024 nr RKU-4/70 3008 Bern SWITZERLAND DECISION to grant authorisation for clinical trial on the basis of Regulation (EU) No 536/2014 of the European Parliament and of the council State Agency of Medicines has received the application from sponsor ETOP IBCSG Partners Foundation on 21.05.2024 to conduct a clinical trial under the conditions stipulated in Regulation (EU) No 536/2014 art 5 (1) and § 991 (1) of Estonian Medicinal Products Act (MPA). Based on art 8 of Regulation (EU) No 536/2014, considering the aspects covered by Part I and Part II of the assessment report, on the basis of § 996 section 1 p 2 and (3) of Medicinal Product Act State Agency of Medicines has decided to give the approval to conduct the clinical study protocol no ETOP25-23 ADOPT-lung under the following conditions: protocol no: ETOP25-23 ADOPT-lung (Version 1.1, dated August 15, 2024) full title of the trial: ETOP 25-23 ADOPT-lung: An international, multicentre, open-label randomised phase III trial to evaluate the benefit of adding adjuvant durvalumab after neoadjuvant chemotherapy plus durvalumab in patients with stage IIB-IIIB (N2) resectable NSCLC sponsor of the trial: ETOP IBCSG Partners Foundation number of subjects in Estonia: 30 starting date: October 2024 principal investigators and study locations: - Dr Kersti Oselin, North Estonia Medical Centre Foundation, J. Sütiste tee 19, 13419 Tallinn, Estonia The addressee may file a challenge with State Agency of Medicines within 30 days as of the day when the addressee became or should have become aware of the decision as prescribed in Code of Administrative Procedure § 71(1). If the addressee wishes to have the decision to Nooruse 1 / 50411 Tartu / 737 4140 / [email protected] / www.ravimiamet.ee / Registrikood 70003477 annulled by the administrative court, he or she may submit a complaint to the Tartu Administrative Court as prescribed in § 7(1) and § 46(1) of the Code of Administrative Court Procedure within 30 days after the date on which the decision was notified to the applicant. (digitally signed) Katrin Kiisk Director General 2 (2)