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Click on the webinar title(s) below for complete description(s).
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| June 22, 2009 |
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| 10:30 am - 12:00 pm (Pacific Standard Time) |
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| How Investigator Budgets Impact Patient Enrollment and Retention and How to Improve Sponsor/CRO/Site Processes to Increase Productivity |
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| Prevention of Fraud and Noncompliance in Clinical Research: What Was and Is Being Done? |
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| FDA's Drug eReg and Listing System: One Year Later |
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| An Introduction and Discussion of FDAAA, FDA’s New Regulatory Authorities |
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| Proactive FDA Safety Meetings: Anticipating Safety Issues |
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| June 23, 2009 |
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| 8:00 - 9:30 am (Pacific Standard Time) |
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| Health Reform and FDAAA: Impact on FDA, Industry, Health Professionals, Consumers, Payers, and Other Stakeholders |
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| Development Safety Update Report (ICH E2F): Update, Current Status, and Major Provisions |
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| Implementing Global Electronic Submissions: The Company and the Regulators Give their Points of View |
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| FDA Goes Global: Domestic Mission – Global Presence (China) |
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| Development of Oncology Products in the EU and US: Can We Do Better? |
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| June 23, 2009 |
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| 10:00 - 11:30 am (Pacific Standard Time) |
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| The Impact of FDAAA and Health Information Technology on Drug Safety, Standards, and Data Stewardship: 2009 Update and Future Plans |
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| FDA Sentinel Initiative |
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| FDA Data Exchange Standards Initiatives |
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| The Cost of Compliance: Clinical Trial Registration and Results Disclosure |
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| European Medicines Agency Town Hall |
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| June 24, 2009 |
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| 8:30 - 10:00 am (Pacific Standard Time) |
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| Pharmacovigilance Agreements |
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| FDA Advisory Committees: New Challenges and Opportunities in the Post-FDAAA Era |
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| Life-cycle Management: Where the Real Challenges Are - Module 3, IND, and NDA |
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| An Introduction to FDA/CDER’s Safety First/Safe Use Postmarketing Safety Initiative |
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| FDA and EMEA Efforts to Harmonize Primary Endpoints |
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| June 24, 2009 |
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| 10:30 am - 12:00 pm (Pacific Standard Time) |
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| Risk Management Best Practice: Integrating Risk Management Strategies into All Phases of the Product Life Cycle |
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| Clinical Automation Systems in Phase 1 Clinical Research |
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| CDISC Pilots |
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| Faster, Better, Cheaper? Working Outside North America and Western Europe |
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| Regulatory Strategy in Global Drug Development |
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| June 25, 2009 |
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| 8:30 - 10:00 am (Pacific Standard Time) |
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| CDER Town Meeting - Part 1 of 2 |
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| June 25, 2009 |
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| 10:30 am - 12:00 pm (Pacific Standard Time) |
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| CDER Town Meeting - Part 2 of 2 |
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