Publications

Workshops and Conferences

  Search All Categories
 |  

Biotechnology Workshop August 2007 [ 8 ]

Type
Doc#
Version
PublishDate
Select
23.04What are biotechnology products?V123-Aug-20071 MB
23.05Immunogenicity of biopharmaceuticalsV123-Aug-2007179 KB
23.06DC formulation and deliveryV123-Aug-2007981 KB
23.07Assessing similarity of biosimilarsV123-Aug-2007597 KB
23.08Regulatory issues and drug product approvalV123-Aug-200748 KB

CAMs CTD Workshop August 2015 [ 3 ]

Type
Doc#
Version
PublishDate
Select
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 ]

Type
Doc#
Version
PublishDate
Select
0007RoadmapV110-Feb-201483 KB
001AgendaV110-Feb-201456 KB
002Introduction V210-Feb-2014114 KB
003Labelling and advertisingV114-Feb-2014473 KB
004LicencesV118-Feb-201459 KB

eCTD [ 9 ]

Type
Doc#
Version
PublishDate
Select
eCTD1Going from CTD to eCTDV121-Feb-2013222 KB
eCTD2Current statusV118-Feb-2013467 KB
eCTD3A global approachV121-Feb-20135 MB
eCTD4Creating a validated eCTD submission Part 1V121-Feb-20131 MB
eCTD5Creating a validated eCTD submission Part 2V121-Feb-2013381 KB

eCTD go live [ 4 ]

Type
Doc#
Version
PublishDate
Select
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 ]

Type
Doc#
Version
PublishDate
Select
9.65GMP workshop for CAMs 22/23 September 2015V207-Sep-201535 KB

Medical Devices [ 1 ]

Type
Doc#
Version
PublishDate
Select
MD001Medical Device Licensing Workshop MCC 26 July 2016V108-Aug-20166 MB

PIC's [ 2 ]

Type
Doc#
Version
PublishDate
Select
9.54PDA V110-Feb-201438 KB
PIC1GMP for APIsV126-Mar-2014572 KB

SARI [ 20 ]

Type
Doc#
Version
PublishDate
Select
SARIEmerging trendsV102-Jul-2015195 KB
SARI 10Exploiting BDDCSV102-Jul-20151 MB
SARI 11GI tract and biorelevant dissolution mediaV102-Jul-20152 MB
SARI 12Impurities and residuesV102-Jul-2015843 KB
SARI 13NanomedicineV102-Jul-20151 MB