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WEBSİTESİ - KAYIT OL
COVID-19
EMA
COVID-19- chloroquine and hydroxychloroquine only to be used in clinical trials or emergency use programmes 01.04.2020
Update on treatments and vaccines against COVID-19 under development 31.03.2020
EMA kılavuz güncellemesi 30 nisan 2*020
COVID-19- chloroquine and hydroxychloroquine only to be used in clinical trials or emergency use programmes 01.04.2020
Update on treatments and vaccines against COVID-19 under development 31.03.2020
EMA kılavuz güncellemesi 30 nisan 2*020
FDA
Coronavirus Treatment Acceleration Program (CTAP) | FDA 02.04.2020
FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic 20.03.2020
Investigational COVID-19 Convalescent Plasma - Emergency INDs FDA 24.03.2020
Emergency Use Authorization of Medical Products and Related Authorities 01.2017
Updated FDA Guideline 16 April 2020
COVID 19: Developing Drugs and Biological Products for Treatment or Prevention Guidance for Industry May 2020
Development and Licensure of Vaccines to Prevent COVID-19 June 2020
Coronavirus Treatment Acceleration Program (CTAP) | FDA 02.04.2020
FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic 20.03.2020
Investigational COVID-19 Convalescent Plasma - Emergency INDs FDA 24.03.2020
Emergency Use Authorization of Medical Products and Related Authorities 01.2017
Updated FDA Guideline 16 April 2020
COVID 19: Developing Drugs and Biological Products for Treatment or Prevention Guidance for Industry May 2020
Development and Licensure of Vaccines to Prevent COVID-19 June 2020
UNESCO
Ethical Considerations from a global perspective 26.03.2020
Ethical Considerations from a global perspective 26.03.2020
WHO
Guidance for Managing Ethical Issues in Infectious Disease Outbreaks 2016
Guidance for Managing Ethical Issues in Infectious Disease Outbreaks 2016
SAĞLIK BAKANLIĞI (MoH)
COVID-19 Pandemisi Nedeniyle Klinik Araştırmalarda Alınacak Tedbirler 19.03.2020
Immun plazma tedarik yazısı 01.04.2020
COVID-19 araştırmaları ile ilgili SB genelgesi 16.04.2020
Klinik Araştırmalar ile Bilimsel Araştırma ve Projeler hakkında yazı 28.04.2020
COVID-19 Pandemisi Nedeniyle Klinik Araştırmalarda Alınacak Tedbirler V2.0
COVID-19 Aşısında Klinik Araştırmalara Başlamak İçin Gereklilikler duyurusu
COVID-19 Pandemisi Nedeniyle Klinik Araştırmalarda Alınacak Tedbirler 19.03.2020
Immun plazma tedarik yazısı 01.04.2020
COVID-19 araştırmaları ile ilgili SB genelgesi 16.04.2020
Klinik Araştırmalar ile Bilimsel Araştırma ve Projeler hakkında yazı 28.04.2020
COVID-19 Pandemisi Nedeniyle Klinik Araştırmalarda Alınacak Tedbirler V2.0
HASTANELER (HOSPITALS)
Dana Farber Direct mailing of sponsor drug 17.03.2020
MD Anderson AuditConnect for External Research Monitors Quick Start Guide 09.03.2020
Memorial Sloan Kettering CR Activities 16.03.2020
Dana Farber Direct mailing of sponsor drug 17.03.2020
MD Anderson AuditConnect for External Research Monitors Quick Start Guide 09.03.2020
Memorial Sloan Kettering CR Activities 16.03.2020
KILAVUZLAR (GUIDELINES)
TransCelerate Protocol Deviation Process Guide March 2020
ICMRA - Global regulatory workshop on COVID-19 vaccine development - March 18
TransCelerate Protocol Deviation Process Guide March 2020
ICMRA - Global regulatory workshop on COVID-19 vaccine development - March 18
KAD (CLINICAL RESEARCH ASSOCIATION)
COVID-19 İÇİN AŞI VE MOLEKÜL GELİŞTİREN ARAŞTIRMACILARIN DİKKATİNE KLİNİK ARAŞTIRMALAR DERNEĞİ DUYURUSU 3.03.2020
COVID-19 İÇİN AŞI VE MOLEKÜL GELİŞTİREN ARAŞTIRMACILARIN DİKKATİNE KLİNİK ARAŞTIRMALAR DERNEĞİ DUYURUSU 3.03.2020
AŞILAR (VACCINES)
FDA Vaccine and Related Biological Product Guidances 2019
EMA Guideline on clinical evaluation of vaccines 18.10.2006
WHO Guidelines on clinical evaluation of vaccines-regulatory expectations 2004.pdf
COVID-19 İÇİN AŞI VE MOLEKÜL GELİŞTİREN ARAŞTIRMACILARIN DİKKATİNE KLİNİK ARAŞTIRMALAR DERNEĞİ DUYURUSU 3.03.2020
FDA Vaccine and Related Biological Product Guidances 2019
EMA Guideline on clinical evaluation of vaccines 18.10.2006
WHO Guidelines on clinical evaluation of vaccines-regulatory expectations 2004.pdf
COVID-19 İÇİN AŞI VE MOLEKÜL GELİŞTİREN ARAŞTIRMACILARIN DİKKATİNE KLİNİK ARAŞTIRMALAR DERNEĞİ DUYURUSU 3.03.2020
STK (NGO)
KAD 8 Mayıs 2020
Bilim Akademisi 12 Mayıs 2020
Türk Toraks Derneği
KAD 8 Mayıs 2020
Bilim Akademisi 12 Mayıs 2020
Türk Toraks Derneği