Vigilanca u postupku kliničkog ispitivanja medicinskog sredstva. Ana Milanović
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1 Vigilanca u postupku kliničkog ispitivanja medicinskog sredstva Ana Milanović
2 Agenda Uvod - kliničko ispitivanje medicinskog sredstva Zakonski okviri u Republici Srbiji i EU vigilanca u kliničkom ispitivanju medicinskog sredstva Zakon o medicinskim sredstvima ( Službeni glasnik RS broj 105 od god.)* *Novi zakon
3 Kliničko ispitivanje medicinskog sredstva Kliničko ispitivanje medicinskog sredstva je: postupak kojim se utvrđuje ili potvrđuje da su njegova bezbednost i efikasnost u skladu sa deklarisanom primenom koju je odredio proizvođač (Zakon o lekovima i MS) svako sistemsko istraživanje, ispitivanje ili studija na jednom ili više ispitanika koje se sprovodi da bi se procenila sigurnost, odnosno performanse medicinskog sredstva (Zakon o MS) Agencija izdaje odobrenje ili potvrdu o prijavi (postmarketinško neintervencijsko KI ili KI MS klase I) za sprovođenje kliničkog ispitivanja MS. Pozitivno mišljenje/odluka Etičkog odbora obavezno za sva KI. Izmene Pravilnika o KI: elektronsko podnošenje zahteva.
4 Zakonski okviri - klinička ispitivanja MS Zakon o lekovima i medicinskim sredstvima ( Sl. glasnik RS br. 30/2010 i 107/2012) Pravilnik o sadržaju zahteva, odnosno dokumentacije za odobrenje kliničkog ispitivanja leka i medicinskog sredstva, kao i način sprovođenja kliničkog ispitivanja leka i medicinskog sredstva ( Sl. glasnik RS, br. 91/2013) Smernice dobre kliničke prakse u kliničkom ispitivanju ( Sl. glasnik RS, br. 28/2008) Pravilnik o načinu prijavljivanja, prikupljanja i praćenja neželjenih reakcija na lekove ( Sl. glasnik RS br. 64/2011)
5 Zakonski okviri vigilanca u kliničkom ispitivanju medicinskog sredstva Šta se prijavljuje: Neželjene reakcije ili neželjeni događaji? Ozbiljni neželjeni događaji ili ozbiljne neželjene reakcije? Samo neočekivani ili samo ozbiljni i neočekivani? Ko prijavljuje, kome se prijavljuje? Rokovi? Obrasci?
6 Zakonski okviri - vigilanca KI MS Zakon o lekovima i medicinskim sredstvima Član 199 shodna primena Član 87: Ako dođe do ozbiljne i neočekivane neželjene reakcije ili ozbiljnog neželjenog događaja u toku sprovođenja kliničkog ispitivanja leka sponzor je dužan da odmah obavesti Agenciju i etički odbor pravnog lica u kome se sprovodi kliničko ispitivanje. Pravilnik o sadržaju zahteva, odnosno dokumentacije za odobrenje KI... Član 49 shodna primena Član 26: Sponzor izveštava Agenciju i etički odbor o svim ozbiljnim neželjenim reakcijama na lek u kliničkom ispitivanju i ozbiljnim neželjenim događajima u kliničkom ispitivanju, u skladu s podzakonskim aktom kojim se uređuje način prijavljivanja, prikupljanja i praćenja neželjenih reakcija na lek. Pravilnik o načinu prijavljivanja, prikupljanja i praćenja neželjenih reakcija na lekove Član 43 - Sponzor ozbiljne, neočekivane neželjene reakcije na lek (SUSAR) bez odlaganja sve istraživače, etički komitet i Agenciju. Član 44 multicentrično KI: SUSAR ispoljene u bilo kojoj od zemalja u kojima se kliničko ispitivanje sprovodi. Član 45 SUSAR: fatalne ili ugrožavaju život, sponzor prijavljuje Agenciji odmah, a najkasnije 7 dana od dana kada je sponzor došao do prvog saznanja (inicijalna prijava). nisu fatalne i ne ugrožavaju život u roku od 15 dana. Zaključno sa članom 52 (followup, obrasci lek...)
7 Zakonski okviri - vigilanca KI MS According to Annex 7 of Directive 90/385/EEC and to Annex X of Directive 93/42/EEC: All serious adverse events must be fully recorded and immediately notified to all competent authorities of the Member States in which the clinical investigation is being performed. MEDDEV 2.7/3 revision 3, May Guidance document - Clinical investigation, clinical evaluation - Clinical investigations: serious adverse event reporting
8 Zakonski okviri - vigilanca KI MS Protokol/Plan kliničkog ispitivanja Direktiva 93/42/EEC Direktiva 90/385/EEC Protokol/ Plan kliničkog ispitivanja MEDDEV ISO Klinička istraživanja medicinskih sredstava na ljudima Dobra klinička praksa
9 MEDDEV 2.7/3 rev. 3 EN ISO Zakon o medicinskim sredstvima Adverse Event (AE): Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device. NOTE 1: This definition includes events related to the investigational device or the comparator. NOTE 2: This definition includes events related to the procedures involved. NOTE 3: For users or other persons, this definition is restricted to events related to investigational medical devices. Serious Adverse Event (SAE): Adverse event that: a) led to a death, injury or permanent impairment to a body structure or a body function. b) led to a serious deterioration in health of the subject, that either resulted in: - a life-threatening illness or injury, or - a permanent impairment of a body structure or a body function, or - in-patient hospitalization or prolongation of existing hospitalization, or - in medical or surgical intervention to prevent life threatening illness c) led to foetal distress, foetal death or a congenital abnormality or birth defect. NOTE 1: Planned hospitalization for pre-existing condition, or a procedure required by the Clinical Investigation Plan, without a serious deterioration in health, is not considered a serious adverse event. Device deficiency: Inadequacy of an investigational medical device related to its identity, quality, durability, reliability, safety or performance. This may include malfunctions, use error, or inadequacy in the information supplied by the manufacturer. Neželjeni događaj u kliničkom ispitivanju je svaka neprijatna medicinska pojava, nenamerna bolest ili povreda ili nepovoljan klinički simptom (uključujući nepovoljan laboratorijski nalaz) pacijenta, korisnika ili drugih lica, bez obzira da li su ili nisu u vezi sa medicinskim sredstvom koje se klinički ispituje. Ova definicija obuhvata događaje u vezi sa medicinskim sredstvom koje se klinički ispituje ili sa medicinskim sredstvom sa kojim se poredi, kao i događaje u vezi sa procedurama koje su uključene. Za korisnike ili druga lica ova definicija je ograničena na događaje koji se odnose na medicinsko sredstvo koje se klinički ispituje. Ozbiljan neželjeni događaj u kliničkom ispitivanju je neželjeni događaj koji je doveo ili može da dovede do smrti ili ozbiljnog pogoršanja zdravlja pacijenta, čija je posledica životno opasna bolest ili povreda ili trajno oštećenje struktura ili funkcije tela, hospitalizacije pacijenta ili produžetka postojećeg bolničkog lečenja, medicinske ili hirurške intervencije kako bi se sprečila bolest ili povreda opasna po život ili trajno oštećenje strukture ili funkcije, kao i koji dovodi do fetalnog distresa, smrti fetusa ili urođenih anomalija ili defekta. Planirana hospitalizacija za prethodno postojeće stanje ili postupak koji zahteva Plan kliničkog ispitivanja, bez ozbiljnog narušavanja zdravlja, ne smatra se ozbiljnim neželjenim događajem. Defekt medicinskog sredstva je nedostatak medicinskog sredstva u odnosu na identitet, kvalitet, izdržljivost, pouzdanost, sigurnost ili performanse. Nedostaci medicinskog sredstva uključuju kvarove, greške prilikom upotrebe i neadekvatno obeležavanje.
10 MEDDEV 2.7/3 rev. 3 REPORTABLE EVENTS UNDER ANNEX 7 AND ANNEX X OF DIRECTIVES 90/385/EEC AND 93/42/EEC RESPECTIVELY any SAE, any Device Deficiency that might have led to a SAE if: a) suitable action had not been taken or b) intervention had not been made or c) if circumstances had been less fortunate new findings/updates in relation to already reported events. Zakon o medicinskim sredstvima: Ako dođe do ozbiljnog neželjenog događaja u toku sprovođenja kliničkog ispitivanja sponzor je dužan da odmah obavesti Agenciju i Etički odbor Srbije. Note: SAEs concerning CE marked devices (e.g. comparators) which meet the vigilance reporting criteria may also need to be handled under the post-market surveillance/vigilance system. CAUSALITY ASSESSMENT: Not related, Unlikely, Possible, Probable, Causal relationship.
11 MEDDEV 2.7/3 rev. 3 Report by sponsor to NCAs. The sponsor must report to the NCAs where the clinical investigation has commenced: - for all reportable events which indicate an imminent risk of death, serious injury, or serious illness and that requires prompt remedial action for other patients/subjects, users or other persons* or a new finding to it: immediately, but not later than 2 calendar days after awareness by sponsor of a new reportable event or of new information in relation with an already reported event.** - any other reportable events or a new finding/update to it: immediately, but not later than 7 calendar days following the date of awareness by the sponsor of the new reportable event or of new information in relation with an already reported event. *This includes: A) events that are of significant and unexpected nature such that they become alarming as a potential public health hazard, e.g. human immunodeficiency virus (HIV) or Creutzfeldt-Jacob Disease (CJD). These concerns may be identified by either the NCA or the manufacturer. B) the possibility of multiple deaths occurring at short intervals **Zakon o medicinskim sredstvima: ozbiljna pretnja po javno zdravlje
12 MEDDEV 2.7/3 revision 3 - Summary Reporting Form The tabular format featured in the Appendix needs to be updated for each reportable event or for new findings/updates to already reported events. It shall be transmitted to all NCAs where the clinical investigation is being performed.
13 Zakon o medicinskim sredstvima Službeni glasnik RS broj 105 od god. Definicije usklađene sa propisima EU Incident vigilanca MS Neželjeni događaj i ozbiljni neželjeni događaj kliničko ispitivanje MS Član 37. Sponzor mora da ima lice odgovorno za dokumentaciju u postupku dobijanja odobrenja za sprovođenje kliničkog ispitivanja, njegove izmene i dopune, kao i za vigilancu, sa kojim je dužan da zaključi ugovoro radu s punim radnim vremenom, kao i da o tome obavesti Agenciju. Član 44. Prijavljivanje ozbiljnog neželjenog događaja u sprovođenju kliničkog ispitivanja: Ako dođe do ozbiljnog neželjenog događaja u toku sprovođenja kliničkog ispitivanja sponzor je dužan da odmah obavesti Agenciju i Etički odbor Srbije.
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15 Agencija za lekove i medicinska sredstva Srbije hygia@alims.gov.rs
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