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Preparing for the Physician Payment Sunshine Implementation: Research, Marketing, & Education
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May 19, 2013
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Online Instruction
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Global
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Online
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Off-label Marketing Regulation in the Wake of the U.S. v. Caronia Decision
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May 19, 2013
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Online Instruction
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Global
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Online
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The Biosimilar User Fee Act: A Closer Look at the Fee Structure, Applications, and Meetings
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May 19, 2013
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Online Instruction
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Global
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Online
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A Closer Look at FDASIA Provisions to Promote Biomedical Innovation
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May 19, 2013
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Online Instruction
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Global
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Online
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Assessing the Benefits and Risks of Medicines: Webinar Series - Part 1: Introduction to the Benefit-Risk - Why is Everyone Talking about Benefit-Risk?
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May 19, 2013
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Online Instruction
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Global
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Online
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Assessing the Benefits and Risks of Medicines: Webinar Series Part 2 - Benefit-Risk Assessment a Changing Regulatory Landscape
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May 19, 2013
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Online Instruction
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Global
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Online
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Assessing the Benefits and Risks of Medicines: Webinar Series - Part 3: Framing for Benefit-Risk Assessment and Communication
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May 19, 2013
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Online Instruction
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Global
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Online
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Assessing the Benefits and Risks of Medicines: Webinar Series - Part 4: Clinical Judgment and Pragmatic Considerations for Endpoint Selection and Display in Benefit-Risk
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May 19, 2013
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Online Instruction
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Global
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Online
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Assessing the Benefits and Risks of Medicines: Webinar Series- Part 5: Stated Choice Methods for Valuing Benefits and Risks
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May 19, 2013
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Online Instruction
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Global
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Online
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2 Part Series: Drug Induced Liver Injury (DILI) In-depth Look into Causality and Biomarkers Puzzle Part 1: DILI Causality: Are Current Tools & Methods Adequate? The Future of Causality
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May 19, 2013
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Online Instruction
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Global
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Online
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2 Part Series: Drug Induced Liver Injury (DILI) In-depth Look into Causality and Biomarkers Puzzle - Part 2: DILI Biomarkers: Where Are We and Where do We Need to Go?
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May 19, 2013
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Online Instruction
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Global
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Online
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Taking the “Risk” Out of Risk-based Monitoring
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May 19, 2013
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Online Instruction
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Global
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Online
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DIA/FDA PDUFA V Conference - Session 7: Ensuring the Success of PDUFA V – FDA, Industry, and Stakeholder Perspectives
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May 19, 2013
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Online Instruction
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Global
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Online
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Two-part Series: Impact of the New European Pharmacovigilance Legislation on International Companies
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May 19, 2013
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Online Instruction
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Global
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Online
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Unwrapping FDA’s UFA Package: What’s Inside the Statute – What’s Next? - Session 4 Track A: Enhanced Drug Development: Accelerated Approval, Greater Access to Experts, Pediatrics,Breakthrough Therapies, GAIN/Antibacterials
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May 19, 2013
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Online Instruction
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Global
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Online
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Unwrapping FDA’s UFA Package: What’s Inside the Statute – What’s Next? - Session 3: Beyond Review Management: Additional Provisions for Regulatory Science, Enhanced Communications and Transparency
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May 19, 2013
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Online Instruction
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Global
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Online
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Unwrapping FDA’s UFA Package: What’s Inside the Statute – What’s Next? - Session 5 Track B: Other Device Reforms
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May 19, 2013
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Online Instruction
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Global
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Online
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Unwrapping FDA’s UFA Package: What’s Inside the Statute – What’s Next? - Session 1: PDUFA, GDUFA, and BsUFA Highlights
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May 19, 2013
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Online Instruction
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Global
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Online
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Unwrapping FDA’s UFA Package: What’s Inside the Statute – What’s Next? - Session 2: MDUFA Highlights
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May 19, 2013
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Online Instruction
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Global
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Online
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Unwrapping FDA’s UFA Package: What’s Inside the Statute – What’s Next? - Session 5 Track A: FDASIA Provisions to Enhance Drug Development: Drug Shortage and Supply Chain
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May 19, 2013
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Online Instruction
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Global
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Online
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DIA/FDA PDUFA V Conference - Session 3: Structured Benefit-Risk Assessment in Regulatory Decision Making, Patient-Focused Drug Development, and Advancing the Use of Patient Reported Outcome (PRO) Measures
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May 19, 2013
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Online Instruction
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Global
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Online
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DIA/FDA PDUFA V Conference - Session 4: Efficiency of Human Drug Review through Required Electronic Submissions
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May 19, 2013
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Online Instruction
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Global
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Online
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DIA/FDA PDUFA V Conference - Session 5: Regulatory Science Enhancements: Meta-Analysis, Pharmacogenomics and Biomarkers, and Rare Diseases
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May 19, 2013
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Online Instruction
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Global
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Online
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DIA/FDA PDUFA V Conference - Session 6: Standardization of Electronic Drug Application Data: A Critical Factor in Improving the Effectiveness and Efficiency of the Regulatory Review Process
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May 19, 2013
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Online Instruction
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Global
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Online
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DIA/FDA PDUFA V Conference - Session 1 - New Review Program for NME NDAs/Original BLAs and Enhanced Communication between FDA and Sponsors During Drug Development
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May 19, 2013
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Online Instruction
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Global
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Online
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DIA/FDA PDUFA V Conference - Session 2: Enhancement and Modernization of the FDA Drug Safety System in PDUFA V
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May 19, 2013
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Online Instruction
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Global
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Online
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Oncology Clinical Trial Endpoints - Keys to Maximizing Success in Your Development Programs
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May 19, 2013
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Online Instruction
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Global
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Online
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BRIDG: An Information Model for Biomedical Research
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May 19, 2013
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Online Instruction
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Global
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Online
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Embracing Globalization within Medical Information
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May 19, 2013
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Online Instruction
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Global
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Online
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Shining the Light on the Value of Customer Insights - The Unique Role of Medical Communications
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May 19, 2013
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Online Instruction
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Global
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Online
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Series: The Impact of Drug Shortages on the Pharmaceutical Industry Part 1: FDA Discusses Drug Shortages: Causes, Trends, Impact and Prevention
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May 19, 2013
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Online Instruction
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Global
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Online
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The Impact of Drug Shortages on the Pharmaceutical Industry Part 4: Potential Policy Solutions to Solve Drug Shortage Problem
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May 19, 2013
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Online Instruction
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Global
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Online
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The Impact of Drug Shortages on the Pharmaceutical Industry Part 3: Coordination and Communication with FDA and Worldwide Regulatory Authorities Regarding Manufacturing and Drug Shortage Issues
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May 19, 2013
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Online Instruction
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Global
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Online
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Series: The Impact of Drug Shortages on the Pharmaceutical Industry Part 2: Drug Shortages within the Pharmaceutical Supply Chain: Impact on Patient Safety and Gray Market Control
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May 19, 2013
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Online Instruction
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Global
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Online
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CDER - Data Submission 101
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May 19, 2013
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Online Instruction
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Global
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Online
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Current Initiatives in the Area of Active Pharmaceutical Ingredients (API)
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May 19, 2013
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Online Instruction
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Global
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Online
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Adult Oncology: Clinical Outcome Assessments (COAs) & Patient-Reported Outcomes (PROs)
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May 19, 2013
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Online Instruction
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Global
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Online
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Two-part Webinar Series: Impact of the New European Pharmacovigilance Legislation and Important Updates
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May 19, 2013
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Online Instruction
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Global
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Online
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The Generic Drug User Fee Agreement -Safety, Access, and Transparency
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May 19, 2013
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Online Instruction
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Global
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Online
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Utilizing the 505(b)(2) Pathway to Streamline and Accelerate a Drug Development Plan
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May 19, 2013
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Online Instruction
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Global
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Online
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