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CLINICAL TRIALS IN RUSSIA from GCP harmonization to results acceptance abroad
ROMAN DRAI MD, PhD R&D Director GEROPHARM
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How to build a GCP? Ethics Safety Reporting Scientific background
Patient Ethics committee Inform consent Safety Investigator’s Brochure Reporting Scientific background Protocol Regulatory Principal Investigator Quality Monitoring Audit/Inspection SOPs Data Integrity Documentation Investigation Master File Medical Department PhV Medical Department Clinical Operations Quality Department Quality Department Data Management Quality Department
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Is GCP in CT the most important?
Good Inspection Clinical Manufacturing Distribution Laboratory Documentation GMP inspection Validation Cold chain CTD Validation Data Management Practice
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Guidelines harmonization
ICH E2A ICH E2A – E2F ICH E2F ICH E3 ICH E6 ICH E8 ICH M4 ICH M7 ICH M8 ICH M9 ICH Q10 ICH Q1A (R2) ICH Q1B ICH Q1C ICH Q1D ICH Q5A ICH Q5B ICH Q5C ICH Q5D ICH Q5E ICH Q6B ICH Q7A ICH Q9 ICH S6 (R1) 2004/10/EC 2010/C 82/01 2013/C 343/01 CHMP/437/04 Rev 1 CHMP/EWP/18504/2006 CHMP/QWP/49313/2005 CPMP/BWP/268/95 CPMP/BWP/328/99 CPMP/BWP/382/97 CPMP/EWP/QWP/1401/98 Rev. 1/ Corr CPMP/ICH/138/95 CPMP/ICH/139/95 CPMP/ICH/2736/99 CPMP/ICH/279/95 CPMP/ICH/280/95 CPMP/ICH/291/95 CPMP/ICH/294/95 CPMP/ICH/295/95 CPMP/ICH/365/96 CPMP/ICH/377/95 CPMP/ICH/381/95 – ICH Q2 (R1) CPMP/ICH/4104/00 CPMP/ICH/4106/00 CPMP/ICH/420/02-ICH Q1E CPMP/ICH/5721/03 CPMP/QWP/122/02 Rev. 1 Corr CPMP/QWP/159/96 Corr. CPMP/QWP/2819/00 Rev. 2 CPMP/QWP/2820/00 Rev. 2 CPMP/QWP/2934/99 CPMP/QWP/609/96/Rev 2 DIRECTIVE 2001/83/EC DIRECTIVE 2001/83/EC (human use) DIRECTIVE 2001/82/EC (animals) EMA/118465/2012 Rev 1* EMA/119871/2012 Rev 1* EMA/169546/2012 EMA/204715/2012 Rev 2* EMA/228028/2012 Rev 1* EMA/541760/2011 EMA/813938/2011 Rev 3 EMA/816292/2011 Rev 1* EMA/816573/2011 Rev 2* EMA/827661/2011 Rev 1* EMA/838713/2011 Rev 2* EMA/873138/2011 Rev 2* EMA/CHMP/287710/2014 – Rev. 6 EMA/CHMP/302620/2017 corr. 1* EMA/CHMP/BMWP/403543/2010 EMA/CHMP/BMWP/652000/2010 EMA/CHMP/BMWP/671292/2010 EMA/CHMP/BMWP/86289/2010 EMA/CHMP/BWP/133540/2017 EMA/CHMP/BWP/247713/2012 EMA/CHMP/BWP/532517/2008 EMA/CHMP/BWP/534898/2008 rev. 1 EMA/CHMP/CVMP/QWP/441071/2011 Rev 2 EMA/CHMP/CVMP/QWP/496873/2018 EMA/CHMP/CVMP/QWP/BWP/70278/2012 Rev. 1 EMA/CHMP/ICH/135/1995 EMA/CHMP/ICH/135/1996 EMA/CHMP/ICH/24235/2006 EMA/CHMP/ICH/309348/2008 EMA/CHMP/ICH/731268/1998 EMA/CHMP/QWP/245074/2015 EMA/CHMP/QWP/428693/2013 EMA/HMPC/201116/ Rev. 3 EMA/HMPC/95714/2013 EMA/INS/MRA/387218/2011 Rev 5 EMEA/CHMP/203927/2005 EMEA/CHMP/BMWP/101695/2006 EMEA/CHMP/BMWP/102046/2006 EMEA/CHMP/BMWP/118264/2007 Rev. 1 EMEA/CHMP/BMWP/14327/2006 EMEA/CHMP/BMWP/301636/2008 Corr.* EMEA/CHMP/BMWP/31329/2005 Rev 1 EMEA/CHMP/BMWP/32775/2005_Rev. 1 EMEA/CHMP/BMWP/42832/2005 Rev. 1 EMEA/CHMP/BMWP/94528/2005 EMEA/CHMP/BWP/398498/2005 EMEA/CHMP/EWP/192217/2009 Rev. 1 Corr. 2** EMEA/CHMP/VEG/134716/2004 EMEA/CPMP/BWP/3068/03 ENTR/F/2/AM/an D(2010) 3374 ENTR/F/2/SF/jr (2009)D/869 ENV/JM/MONO(2002)9 ENV/JM/MONO(2004)26 ENV/JM/MONO(99)20 ENV/JM/MONO(99)23 ENV/JM/MONO(99)24 ENV/MC/CHEM(98)16 European Community Volume 2C: Guidelines OCDE/GD(95)115 OECD/GD(95)66 PI 002-3
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Thanks for your attention!
Roman Drai MD, PhD. R&D Director 191144, Saint-Petersburg, Degtyarny lane, 11Б phone.: +7(812) (443)
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