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Fall 2011 Registration Form indd - Federation of Health Regulatory

Fall 2011 Registration Form indd - Federation of Health Regulatory-2025

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The document outlines an event organized by the Federation of Health Regulatory Colleges of Ontario, scheduled for October 20, 2011, focusing on conducting discipline hearings. It features a panel presentation moderated by Richard Steinecke, discussing the theories, principles, and effectiveness of regulatory sanctions. The document includes detailed profiles of distinguished panellists Lorne Sossin, Marlys Edwardh, and Linda Rothstein, highlighting their expertise in law and contributions to the field. Additionally, it provides registration information, rates for attendance (both in-person and via webcast), and cancellation policies.

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What are the 5 investigational requirements for a new drug?

Contents: This component of an IND application includes the Chemistry, Manufacturing, and Control information for: (1) drug substance; (2) drug product; (3) placebo formulation, if applicable; (4) labeling information for the labeled products relevant to the investigational drug; and (5) an environmental analysis for

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The IND application must contain information in three broad areas: Animal Pharmacology and Toxicology Studies - Preclinical data to permit an assessment as to whether the product is reasonably safe for initial testing in humans. Also included are any previous experience with the drug in humans (often foreign use).

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Whether an IND is needed to conduct a clinical investigation of a marketed drug primarily depends on the intent of the investigation and the degree of risk associated with the use of the drug in the investigation.

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Fall 2011 Registration Form indd - Federation of Health Regulatory-2025

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