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Biotechnology Workshop August 2007 [ 8 ]

Type	Doc#	Title	Version	PublishDate	Size	Select
	23.07	Assessing similarity of biosimilars	V1	23-Aug-2007	597 KB
	23.11	Biotech 2007 summary	V1	23-Aug-2007	52 KB
	23.09	Clinical trials for biotechnology medicines	V1	23-Aug-2007	26 KB
	23.06	DC formulation and delivery	V1	23-Aug-2007	981 KB
	23.12	Holloway biotech	V1	23-Aug-2007	375 KB

CAMs CTD Workshop August 2015 [ 3 ]

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

CAMs February 2014 [ 9 ]

Type	Doc#	Title	Version	PublishDate	Size	Select
	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
	005	Pharmacovigilance	V1	11-Feb-2014	659 KB

eCTD [ 9 ]

Type	Doc#	Title	Version	PublishDate	Size	Select
	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
	eCTD2	Current status	V1	18-Feb-2013	467 KB
	eCTD6	EURS is Yours	V1	21-Feb-2013	954 KB

eCTD go live [ 4 ]

Type	Doc#	Title	Version	PublishDate	Size	Select
	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
	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

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
	PIC1	GMP for APIs	V1	26-Mar-2014	572 KB
	9.54	PDA	V1	10-Feb-2014	38 KB

SARI [ 20 ]

Type	Doc#	Title	Version	PublishDate	Size	Select
	SARI 5	Access to medicines	V1	19-Mar-2014	1 MB
	SARI 6	BCS Biowaivers	V1	19-Mar-2014	1 MB
	SARI 7	Bioresponsive vaginal drug delivery devices	V1	19-Mar-2015	2 MB
	SARI 7	Biosimilar monoclonal antibodies	V1	19-Mar-2014	966 KB
	SARI 4	Biowaivers	V1	13-Feb-2014	572 KB