1. CLINICAL TRIALS IN RUSSIA from GCP harmonization to results acceptance abroad
ROMAN DRAI
MD, PhD
R&D Director
GEROPHARM

2. 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

3. Is GCP in CT the most important?
Good
Inspection
Clinical
Manufacturing
Distribution
Laboratory
Documentation
GMP inspection
Validation
Cold chain
CTD
Validation
Data Management
Practice

4. 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

5. Thanks for your attention!
Roman Drai
MD, PhD.
R&D Director
191144, Saint-Petersburg, Degtyarny lane, 11Б
phone.: +7(812) (443)