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DIA 2017 Annual Meeting

Winif

Strategic Regulatory Partners, LLC
Principal
U.S.A.

Regulatory strategy; combination products.

8:30am CDT

#26: Smart, Innovative Risk-based Auditing: Shifting the Paradigm S404bc

8:30am CDT

#102: The Evolution of Evidence Generation: Real-World Evidence and the Next Generation of Decision Making S100a #103: The Future of Patient Engagement: Measuring What Matters S100c

11:00am CDT

#123: Calling All Angels to the Valley of Death S405b #124: Exploration of PK/PD in NDA Enabling or Early Proof of Concept Studies S402ab #126: Breaking Down the Wall for FDA to Leverage Real World Data N226 #128: Office of Pharmaceutical Quality Update: Innovative Approaches in Regulatory Assessment N230b

8:00am CDT

#201: Paying for Value in Biopharmaceuticals: Trends in the United States S105

2:00pm CDT

#240: Mobile Health: Participatory Research N426c #247: Best Practice for Advisory Committee Meeting Preparation S504abc #254: New Considerations in Benefit-Risk Management S403ab

2:45pm CDT

#265: Patient Engagement in Study Endpoints: Will the Rising Tide Lift All Boats? S400 Concourse

10:30am CDT

#309: Big Data: Combining Registries and Legacy Clinical Trial Databases S505ab #318: IMEDS: A Public-Private Partnership to Facilitate Real World Evidence Generation Based on the FDA's Sentinel System S404a #322: Is the Future Bright for Treatment of Neurodegenerative Diseases? S504abc #328: Real-World Data to Real World Evidence for Assessing Efficacy and Effectiveness N230b

12:45pm CDT

#335: Real-World Application of Risk-Based Monitoring Aisle 300/400

2:00pm CDT

#339: Off-Label Communications to Health Care Providers and Consumers N229 #345: Global Perspective on ICH: Part 1 of 2 N228 #346: Understanding the New Common Rule and Its Impact to Industry N426b #354: Experimental Studies: New Approaches to Study Designs to Facilitate Early Phase Decision Making S405a #355: FDA, NIH, and TransCelerate Collaborate to Accelerate Drug Development Through Protocol Harmonization S404bc

4:00pm CDT

#364: Risk-Based Monitoring: Convergence of Technology, Processes, and People: Panel Discussion N226 #366: Are We Ready for Telemedicine-Powered Clinical Trials? S504abc #368: FDA Update on Prescription Drug Promotion N227b #371: Global and Regional Collaboration Initiatives: Challenges, Opportunities, and Case Studies S403ab #374: Global Perspective on ICH: Part 2 of 2 N228 #380: Effective Portfolio Management and How to Ensure You Get the Value Out of the Decisions Made N426a #382: Patient-Relevant, Fit-For-Purpose Endpoints: If You Can Believe It, You Can Achieve It S405a #385: Patient-Centric Development Assessment N426c

9:00am CDT

#401: FDA Forum S105

10:45am CDT

#409: Trial Master File: MHRA/EMA Inspections and Sponsor Audit Learnings S402ab #412: EMA/ FDA Question Time S105