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Biotechnology Workshop August 2007 [ 8 ]

Type	Doc#	Title	Version	PublishDate	Size	Select
	23.09	Clinical trials for biotechnology medicines	V1	23-Aug-2007	26 KB
	23.11	Biotech 2007 summary	V1	23-Aug-2007	52 KB
	23.12	Holloway biotech	V1	23-Aug-2007	375 KB

CAMs CTD Workshop August 2015 [ 3 ]

Type	Doc#	Title	Version	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	PublishDate	Size	Select
	005	Pharmacovigilance	V1	11-Feb-2014	659 KB
	006	Quality safety assurance	V1	11-Aug-2014	133 KB
	007	Registration	V1	12-Aug-2015	984 KB
	008	Vitamins and probiotics	V1	11-Feb-2014	66 KB

eCTD [ 9 ]

Type	Doc#	Title	Version	PublishDate	Size	Select
	eCTD6	EURS is Yours	V1	21-Feb-2013	954 KB
	eCTD7	MCC Validation Criteria	V1	21-Feb-2013	378 KB
	eCTD8	Validation of Submission	V1	21-Feb-2013	769 KB
	eCTD9	Module 1 Specification	V1	21-Feb-2013	1 MB

eCTD go live [ 4 ]

Type	Doc#	Title	Version	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	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	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	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	PublishDate	Size	Select
	SARI 13	Plantbased materials	V1	02-Jul-2015	2 MB
	SARI 14	QA supply chain	V1	02-Jul-2015	4 MB
	SARI 15	Quality of APIs	V1	02-Jul-2015	1 MB
	SARI 16	Topical formulations	V1	02-Jul-2015	2 MB
	SARI 17	Transporters	V1	02-Jul-2015	1 MB