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Biotechnology Workshop August 2007 [ 8 ]

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23.04What are biotechnology products?V123-Aug-20071 MB
23.05Immunogenicity of biopharmaceuticalsV123-Aug-2007179 KB
23.09Clinical trials for biotechnology medicinesV123-Aug-200726 KB
23.12Holloway biotechV123-Aug-2007375 KB
23.08Regulatory issues and drug product approvalV123-Aug-200748 KB

CAMs CTD Workshop August 2015 [ 3 ]

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

CAMs February 2014 [ 9 ]

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002Introduction V210-Feb-2014114 KB
006Quality safety assuranceV111-Aug-2014133 KB
003Labelling and advertisingV114-Feb-2014473 KB
001AgendaV110-Feb-201456 KB
004LicencesV118-Feb-201459 KB

eCTD [ 9 ]

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eCTD4Creating a validated eCTD submission Part 1V121-Feb-20131 MB
eCTD9Module 1 SpecificationV121-Feb-20131 MB
eCTD1Going from CTD to eCTDV121-Feb-2013222 KB
eCTD7MCC Validation CriteriaV121-Feb-2013378 KB
eCTD5Creating a validated eCTD submission Part 2V121-Feb-2013381 KB

eCTD go live [ 4 ]

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

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 10Exploiting BDDCSV102-Jul-20151 MB
SARI 13NanomedicineV102-Jul-20151 MB
SARI 15Quality of APIsV102-Jul-20151 MB
SARI 17TransportersV102-Jul-20151 MB
SARI 2Impact of Pharmaceutical Sciences on HealthcareV118-Mar-20141 MB