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Biotechnology Workshop August 2007 [ 8 ]

Type	Doc#	Title	Version	SubVersion	PublishDate	Size	Select
	23.04	What are biotechnology products?	V1		23-Aug-2007	1 MB
	23.05	Immunogenicity of biopharmaceuticals	V1		23-Aug-2007	179 KB
	23.06	DC formulation and delivery	V1		23-Aug-2007	981 KB
	23.07	Assessing similarity of biosimilars	V1		23-Aug-2007	597 KB
	23.08	Regulatory issues and drug product approval	V1		23-Aug-2007	48 KB

CAMs CTD Workshop August 2015 [ 3 ]

Type	Doc#	Title	Version	SubVersion	PublishDate	Size	Select
	001	Completion of the CTD for a complementary medicine	V1		23-Sep-2015	877 KB
	002	CM CTD Module 1, Screening and Presentation	V1		23-Sep-2015	5 MB
	003	CM An MCC perspective on Quality	V1		23-Sep-2015	1 MB

CAMs February 2014 [ 9 ]

Type	Doc#	Title	Version	SubVersion	PublishDate	Size	Select
	0007	Roadmap	V1		10-Feb-2014	83 KB
	001	Agenda	V1		10-Feb-2014	56 KB
	002	Introduction	V2		10-Feb-2014	114 KB
	003	Labelling and advertising	V1		14-Feb-2014	473 KB
	004	Licences	V1		18-Feb-2014	59 KB

eCTD [ 9 ]

Type	Doc#	Title	Version	SubVersion	PublishDate	Size	Select
	eCTD1	Going from CTD to eCTD	V1		21-Feb-2013	222 KB
	eCTD2	Current status	V1		18-Feb-2013	467 KB
	eCTD3	A global approach	V1		21-Feb-2013	5 MB
	eCTD4	Creating a validated eCTD submission Part 1	V1		21-Feb-2013	1 MB
	eCTD5	Creating a validated eCTD submission Part 2	V1		21-Feb-2013	381 KB

eCTD go live [ 4 ]

Type	Doc#	Title	Version	SubVersion	PublishDate	Size	Select
	eCTD GL01	Introduction and Best Practices about electronic submission in eCTD format	V1		22-Nov-2016	2 MB
	eCTD GL02	Update of eCTD Module 1 specification for South Africa	V1		22-Nov-2016	1 MB
	eCTD GL03	eCTD Experiences from the Pilot	V1		22-Nov-2016	2 MB
	eCTD GL04	Experiences from Pilot from Industry perspective	V1		22-Nov-2016	178 KB

Good Manufacturing Practice [ 1 ]

Type	Doc#	Title	Version	SubVersion	PublishDate	Size	Select
	9.65	GMP workshop for CAMs 22/23 September 2015	V2		07-Sep-2015	35 KB

Medical Devices [ 1 ]

Type	Doc#	Title	Version	SubVersion	PublishDate	Size	Select
	MD001	Medical Device Licensing Workshop MCC 26 July 2016	V1		08-Aug-2016	6 MB

PIC’s [ 2 ]

Type	Doc#	Title	Version	SubVersion	PublishDate	Size	Select
	9.54	PDA	V1		10-Feb-2014	38 KB
	PIC1	GMP for APIs	V1		26-Mar-2014	572 KB

SARI [ 20 ]

Type	Doc#	Title	Version	SubVersion	PublishDate	Size	Select
	SARI	Emerging trends	V1		02-Jul-2015	195 KB
	SARI 10	Exploiting BDDCS	V1		02-Jul-2015	1 MB
	SARI 11	GI tract and biorelevant dissolution media	V1		02-Jul-2015	2 MB
	SARI 12	Impurities and residues	V1		02-Jul-2015	843 KB
	SARI 13	Nanomedicine	V1		02-Jul-2015	1 MB