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Tuesday, June 26

7:00am EDT

8:00am EDT

#202: Quantifying the Impact of Credentialed Clinical Research Site Professionals on Clinical Trial Conduct Quality Room 257AB #203: Utilizing and Understanding Real World Evidence Solutions to Efficiently Recruit the Most Appropriate Patients and Sites for Clinical Trials Room 258AB #207: Novel Approaches for Accessing the CNS: Nonclinical and Clinical Challenges Room 156ABC #209: Oversight in the Era of E6 (R2) Room 205C #201: Generic Drug Products: Comparison of Safety Profile With Branded Cousin Room 253AB #204: FDA Data Standards Update Room 209 #205: Best Practices for Implementing Lay Summaries and Communicating Results to Patients Room 210C #206: Incorporating Patient Input Into US Food and Drug Administration’s Medical Product Development and Regulatory Decision Making Room 151AB #208: Effective Management of Internal Stakeholders and External Strategic Partners from Multiple Perspectives: Non-Profit, CRO, and Pharmaceutical Industry Room 153ABC #210: Artificial Intelligence: The Future of Regulatory Affairs Room 206AB #211: Update on Collaboration and Trends in Global Companion Diagnostics Room 208 #212: Global Regulatory Strategies for Biosimilars Room 204AB #213: 2018 Policy Mash-Up: New Shifts in the Healthcare Market and What They May Mean for Patients and the Biopharma Industry Room 205AB #214: CMC Challenges for Breakthrough Therapies and Other Worldwide Accelerated Approval Programs Room 253C #215: Pediatric and Rare Disease Drug Development Room 256 #216: Early HTA Scientific Advice: Does it Improve Internal Company Decision-Making and Ensure Predictability of HTA Outcome? Room 258C #218: Building Your Brand Room 254AB #217: Triple-A RWE: Adequate Data, Appropriate Study Designs, and Actionable Evidence Room 210AB

9:00am EDT

9:15am EDT

9:30am EDT

9:45am EDT

10:00am EDT

10:30am EDT

#228: Global Clinical Trials: Lessons in Effective Execution Room 258AB #231: Automation with Intelligence: From Standard-Based Solution to Metadata-Driven Automation Room 209 #236: Executives Respond to the State of the Industry Report on Risk-Based Approaches in Clinical Trials: Opportunity or Threat? Room 205C #237: Expanded Access: Where Are We Now? Room 206AB #226: Regulators’ Utilization of Real-World Data in Pharmacovigilance Activities Room 253AB #227: Digital Data Flow from Protocol to Report: TransCelerate’s Common Protocol Template and the Art of the Possible Room 257AB #229: Mobile Reported Outcomes: A Forum on Patient and Caregiver Assessments Room 258C #230: Common Data Model Harmonization for Evidence Generation Room 208 #232: Digital Data and New Technologies to Drive Customer Impact in Medical Affairs, Medical Writing, and Medical Communications Room 210C #233: The Patient's Assessment of the Patient-Focused Drug Development Meeting Initiatives Room 151AB #234: Personalized Medicine Approaches During Early-Phase Clinical Research Room 156ABC #235: The Adventures of Patient Experience in Drug Development Room 252AB #238: The European Medical Devices Regulation and MDUFA IV: One Year On - Is It Any Clearer? Room 204AB #239: Generic Drug Town Hall Room 205AB #240: Biosimilars: Demonstrating Structural and Functional Similarity Room 253C #241: Time-to-Event Analysis in Clinical Trials Room 256 #242: Unmet Medical Need: Can the Stakeholders Align? Progress to Date Room 153ABC #243: Global Perspectives on Patient Engagement Room 210AB

11:30am EDT

12:00pm EDT

12:10pm EDT

1:10pm EDT

1:15pm EDT

1:30pm EDT

2:00pm EDT

#255: Use of Electronic Health Records (EHRs) as eSource in Clinical Investigations Room 208 #260: Optimizing Clinical Development With Adaptive Trial Designs Room 156ABC #267: Developing and Partnering on Evidence for Outcomes and Value Assessment: Standardizing Measurement for Patient-Centered Care Room 252AB #269A: DIA Regulatory Community Round Table Discussion: Global Regulatory Strategies for Biosimilars Community Zone NE Lobby #251: Risk Management: New Directions Room 253AB #252: Do the End(point)s Justify the Means? A Peak at Endpoints Accepted by FDA With an Eye Towards Mobile Technology Collection Room 257AB #253: Digitizing a Patient-Focused Clinical Trial Experience Room 258AB #254: Risk-Based Monitoring for Master Protocol Study: A Dilemma and Possible Ways to Go Room 258C #256: CTD Regulatory Defense Strategies: How Best to Prepare Your Response to Health Authority Queries Room 210C #257: Globalizing and Regionalizing Medical Information Contact Centers Room 209 #258: Reaching the Underserved: Methods to Ensure Diversity and Inclusion for Patient Research, Clinical Trials, and Advisory Panels Room 151AB #259: Measuring the Impact of Patient Engagement: What to Ask Depends on Who You Ask Room 254AB #261: Project Management Throwdown: How Not to Get Chopped Room 153ABC #262: The Risk Assessment Is Done: Now What? A Guide to Setting Up a Centralized Monitoring Plan Room 205C #263: Navigating the Regulatory Landscape of Drug-Device Combination Products Room 204AB #264: Global Development Using Expedited Pathways in Established and Emerging Markets Room 206AB #265: ICH M9 BCS-Based Biowaivers Room 253C #266: User-Friendly Tools for Study Planning and Analysis Room 256 #268: Future of PharmaTech Room 210AB

2:15pm EDT

3:00pm EDT

3:15pm EDT

3:30pm EDT

3:40pm EDT

4:15pm EDT

#284: Using Advocacy Partnerships to Improve Real World Evidence in Clinical Trials Room 151AB #288: Is It Time to Change the Content and Format of Labeling? Room 205AB #293: Medical Monitoring in Non-Interventional Studies: Need for Medical Leadership and Study Primary Care Management Room 257AB #294: Sustainable Healthcare Funding Room 258AB #276: Patient Engagement in Pharmacovigilance Room 253AB #277: Pharmacovigilance: No Longer Going it Alone Room 253C #278: Challenges and Opportunities in Data Access and Methodology Development for Post-Market Generic Drug Monitoring Room 252AB #279: Redefining the Site Investigator's Experience Room 153ABC #280: Debunking Decentralized Trials: Sharing Breakthroughs and Deal Breakers Room 254AB #281: Future of Endpoints Room 258C #282: Building up Efficiencies, Breaking Down Barriers: Using Mobile Technology for Data Capture in Clinical Trials Room 209 #283: Evolving Roles and Responsibilities for Medical Affairs Professionals Room 210C #285: Gene Therapy: Advances in Translating Technology Room 156ABC #286: Which Regulatory Project Management Staff at FDA Should You Engage With? When and How? Room 157AB #287: The Letter and Spirit of Risk-Based Monitoring: How to Creatively Implement Risk-Based Modeling and Unlock the Potential of the Team Room 205C #289: Electronic Submissions Demystified Room 204AB #290: Priority Review Vouchers: Here to Stay and Worth the Effort? Room 206AB #291: ICH Q12: A Paradigm Changing Guidance for Post-Approval Changes? Room 208 #292: Complex Innovative Designs and Model-Informed Drug Development Related: PDUFA VI Pilot Programs Room 256

4:30pm EDT


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