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Technology / Clinical Data Management / Pharmaceutical industry / Pharmaceuticals policy / Drug safety / Electronic Common Technical Document / Common Technical Document / International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use / Drug Master File / Medicine / Clinical research / Research


Draft Guidance Document - Preparatin of Drug Regulatory Activities in the Electronic Common Technical Document Format
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Document Date: 2013-07-09 17:16:48

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File Size: 2,05 MB

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City

Ottawa / /

Company

ICH M2 Expert Working Group / /

Country

Canada / /

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Event

FDA Phase / /

Facility

Therapeutic Products Directorate Health Canada Finance Building / /

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IndustryTerm

drug/device / drug product / health products / combination product / food / /

Organization

Health Products and Food Branch / Post-Authorization Division / Therapeutic Products Directorate / Biologics and Genetic Therapies Directorate / Submission and Information Policy Division / Council For International Organizations of Medical Sciences / Marketed Health Products Directorate / /

Person

Lot Release / /

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Position

Minister of Health / Minister of Public Works / General / /

Product

eCTD / New Drug / /

ProvinceOrState

Ontario / /

Technology

dtd / PDF / /

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