Moving from US FDA focus to Global focus–Imortance of Standards从美国FDA关注全球关注的焦点–标准的重要性.pptVIP

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Moving from US FDA focus to Global focus–Imortance of Standards从美国FDA关注全球关注的焦点–标准的重要性.ppt

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Moving from US FDA focus to Global focus–Imortance of Standards从美国FDA关注全球关注的焦点–标准的重要性

Name, date Name, date Moving from US FDA focus to Global focus – Importance of Standards Margaret Minkwitz Sept 16, 2010 Definitions of terms used Health authorities – agencies responsible for review and approval of new medicines (US Food Drug Administration (FDA) Common Technical Document – Internationally agreed structure and content details for a submission to the health authorities Standards: agreed format and data structure details Includes meaning of the variables Details in agreed structure Globally agreed and maintained – updated and reviewed Version controlled Do we have a common understanding of the issues? Are we talking the same language? Health Authorities: reasons to standardize data collection and reporting Ability to evaluate data across products / companies Evaluation of common effects across treatments (class effects) Ability to use common tools to verify the reported results Primarily the FDA Other health authorities starting to follow suit Ability to compare across data presented on public web sites – common terms and reporting structure Ability to standardize the product labels so that doctors can compare the properties of treatments when deciding which treatment to prescribe to a patient Additional reasons for companies to embrace standards Co-development – 2 companies sharing the development costs and risks (example: AstraZeneca and BMS – ONGLYZA? for diabetes, TV ad notes both companies) Outsource partnering with a Contract Research Organization (CRO) for study conduct and reporting CRO partner doing studies for Pharmaceutical Company From protocol to report (full service) Strategic (portion of the study outsourced – analysis programs) In-licensing product from development at another company Work with some studies in original company sources Need to integrate that data with new studies done International Conference on Harmonization Health Authorities agreed to accept the Common Technical Document (CTD) for submissions for market author