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Fall 2011 Registration Form indd - Federation of Health Regulatory

Fall 2011 Registration Form indd - Federation of Health Regulatory-2026

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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 biographies of distinguished panellists Lorne Sossin, Marlys Edwardh, and Linda Rothstein, highlighting their expertise in law and contributions to legal education. Additionally, it provides registration details, fees for attendance (both in-person and via webcast), and cancellation policies.

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Click ‘Get Form’ to open the Fall 2011 Registration Form in our editor.
Begin by filling out your contact information. Select your title (Dr., Mr., Ms., Mrs., or Other) and enter your name, organization, and address details.
Provide your phone number, fax number, and email address. If someone else is completing the form for you, include their name and contact information.
Indicate how you would like to receive registration information by selecting either 'Registrant', 'Person completing form', or 'Both'.
Choose your attendance option: In-person or Webcast. Note any dietary restrictions if attending in person.
Complete the rate schedule section based on your membership status and desired programs. Ensure to calculate the total including HST.
Select your payment method and provide necessary details for credit card payments if applicable.
Review all entered information for accuracy before submitting the completed form via email, fax, or mail as indicated.

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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

What is included in the IND application?

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).

How do you determine if you need an IND?

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.

What does IND mean in medical terms?

Once an IND is in effect, a sponsor may ship the investigational product to the investigator(s) named in the IND application. The regulations at 21 CFR parts 50, 56, and 312 do not require IRB approval (in addition to the IND being in effect) before shipping the investigational product.

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Phase 1: The drug is tested in 20 to 100 healthy volunteers to determine its safety at low doses. About 70% of candidate drugs advance to Phase 2. Phase 2: The drug is tested for both efficacy and safety in up to several hundred people with the targeted disease.

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Fall 2011 Registration Form indd - Federation of Health Regulatory-2026

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