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Biotechnology Workshop August 2007 [ 8 ]

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23.09Clinical trials for biotechnology medicinesV123-Aug-200726 KB
23.11Biotech 2007 summaryV123-Aug-200752 KB
23.12Holloway biotechV123-Aug-2007375 KB

CAMs CTD Workshop August 2015 [ 3 ]

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001Completion of the CTD for a complementary medicineV123-Sep-2015877 KB
002CM CTD Module 1, Screening and PresentationV123-Sep-20155 MB
003CM An MCC perspective on QualityV123-Sep-20151 MB

CAMs February 2014 [ 9 ]

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005PharmacovigilanceV111-Feb-2014659 KB
006Quality safety assuranceV111-Aug-2014133 KB
007RegistrationV112-Aug-2015984 KB
008Vitamins and probioticsV111-Feb-201466 KB

eCTD [ 9 ]

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eCTD6EURS is YoursV121-Feb-2013954 KB
eCTD7MCC Validation CriteriaV121-Feb-2013378 KB
eCTD8Validation of SubmissionV121-Feb-2013769 KB
eCTD9Module 1 SpecificationV121-Feb-20131 MB

eCTD go live [ 4 ]

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eCTD GL01Introduction and Best Practices about electronic submission in eCTD formatV122-Nov-20162 MB
eCTD GL02Update of eCTD Module 1 specification for South Africa V122-Nov-20161 MB
eCTD GL03eCTD Experiences from the PilotV122-Nov-20162 MB
eCTD GL04Experiences from Pilot from Industry perspectiveV122-Nov-2016178 KB

Good Manufacturing Practice [ 1 ]

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9.65GMP workshop for CAMs 22/23 September 2015V207-Sep-201535 KB

Medical Devices [ 1 ]

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MD001Medical Device Licensing Workshop MCC 26 July 2016V108-Aug-20166 MB

PIC's [ 2 ]

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9.54PDA V110-Feb-201438 KB
PIC1GMP for APIsV126-Mar-2014572 KB

SARI [ 20 ]

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SARI 13Plantbased materials V102-Jul-20152 MB
SARI 14QA supply chainV102-Jul-20154 MB
SARI 15Quality of APIsV102-Jul-20151 MB
SARI 16Topical formulationsV102-Jul-20152 MB
SARI 17TransportersV102-Jul-20151 MB