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Tuesday, June 25
 

7:00am

7:30am

8:00am

#202: Updates and Lessons Learned from Novel Approaches to Pharmacovigilance Collaboration Room 6D #201: To Err is Human: Progress and Challenges in the Prevention of Medication Errors Room 6C #203: eConsent Done Right Room 11A #204: Protocol Developments of the Future Room 9 #205: Driving Enrollment with a Patient-Centric Focus to Artificial Intelligence Room 10 #206: Single Source of Truth, Integrations, or IoT (Internet of Things): Exploring Ways to Improve Connectedness of Clinical Data Room 1AB #207: Leveraging Artificial Intelligence and Natural Language Processing in Medical Writing Room 4 #208: Patient Focus as Part of the Regulatory Affairs DNA: Opportunities and Challenges Room 5AB #209: Emerging Issues in CRISPR and Gene Editing Symposium Room 2 #210: Increasing Personal Resilience To Manage Change Room 15AB #212: Translating Academic Research into Product Development: Integrating GXPs into the Process (Part 1 of 4) Room 16AB #211: Pharmacovigilance Reporting and Quality Room 17AB #213: Facilitating Access: Patient Perspectives on a Streamlined Development Approach for Treatments for Severely-Debilitating or Life-Threatening Diseases Room 6B #214: Global Pediatric Policy Update: Are You Ready to Implement FDARA Section 504? Room 6F #216: Identifying the Reference Listed Drug for ANDA Submission, Overview of FDA’s Orange Book, and Exclusivities for NDAs and ANDAs Room 11B #215: Conducting Clinical Trials with GMOs: Strategies to Overcome Regulatory, Operational, and Patient Enrollment Challenges Room 6E #217: Quality Considerations for Complex Generics Room 8 #218: Real World Data to Real World Evidence Room 3 #219: Personalized Healthcare and Clinical Outcomes: How Real World Endpoints Can Improve Approval and Access to Medicine? Room 14B #220: DISC and RISK: How DISC Profile in Clinical Trial Teams Impact Implementation of Risk-Based Approaches Room 14A

9:00am

9:15am

9:30am

9:45am

10:00am

10:30am

#228: Emerging Safety Challenges in New Oncology Treatments Room 6D #229: An Industry Collaboration on Pharmacovigilance Analytics Room 6C #230: Assessing Opportunities to Improve Outsourcing Oversight and the Vendor Qualification Assessment Process Room 10 #231: Outcomes, Endpoints, and Methods Supporting Oncology and Alzheimer Therapies Room 9 #232: Retooling Risk Assessment to Align with ICH-E6(R2) and Connect to Centralized Monitoring and Risk-Based Monitoring Room 11A #233: Creating Clarity: Changes at CDISC to Make Standards Implementation Easier for all Stakeholders Room 1AB #234: Quality and Compliance Management in Medical Information/Medical Affairs Room 4 #236: Our Doors are Open! Pathways and Programs for Patient Stakeholders to Engage with FDA Room 5AB #235: Walking the Talk: Using Home Nursing as a Patient-Centric Service in Clinical Trials - From Multiple Perspectives Room 11B #237: The Rare Disease Experience in Clinical Trials Room 2 #238: Build and Leverage Your Networks to Influence Stakeholders Room 15AB #239: Improving Clinical Trial Risk Management: How To Leverage the IRB's Designed Purpose Room 17AB #240: Harmonizing Regulatory Science Through the International Council for Harmonization (ICH) Room 6F #241: PMDA Town Hall Room 6E #242: Use of Real World Evidence to Support Regulatory Decision-Making: First-Year Findings From the RCT-DUPLICATE Project Room 6B #243: The Future of Combination Products in the EU Room 16AB #244: Where Quality Meets Safety and Efficacy: A Conversation with CMC Experts Room 8 #245: Artificial Intelligence Enhanced Data Analytics for Clinical Trials Room 3 #246: How Employers are Reinventing Healthcare and What it Means for Research Participation and Evidence Room 14B #247: Pregnancy, Breastfeeding, Childcare, Oh My! Finding a Balance for New Moms Room 14A

11:30am

11:40am

11:45am

12:15pm

12:40pm

1:40pm

2:00pm

#274 EE: Pharma Powered by the Digital E and E Area Exh Hall #254.1 RT: Round Table Discussion: Current Initiatives on Patient Involvement in the Medicinal Product Lifecycle: CIOMS XI Community Zone Sails Pav DIAlogue Session 2: Publications Meet Up - Inside the DIA Journal Community Area Sails Pav #255: Pharma and Regulatory Perspectives on Machine Learning Applications in Pharmacovigilance Room 6C #256: Wearables and Patient Technologies Utilized in Clinical Trials Room 10 #257: Clinical Trial Diversity: Moving from Admiring the Problem to Solving it Room 11A #258: Build-a-Bot Workshop: Design and Build a Conversational Agent that Speaks for You Room 9 #259: FDA Data Standards Update Room 1AB #260: Clinical Trial Disclosure and Transparency: Intersection of Regulators, Industry, and Patients Room 4 #262: Measuring the Impact of Patient Engagement Activities in Medicines R&D: A Way to Sustain the Cultural Change? Room 16AB #261: Patient Experience Data: How Could this Data Enhance Decision-Making at Different Stages of Medical Product Development? Room 5AB #264: Immuno-Oncology Product Development: Overcoming Scientific and Regulatory Challenges Room 2 #263: Drug Development for Ocular Disease, New Therapies, Regulations, and Patient Perspectives Room 6D #265: Decision Leadership: How Using a Structured Approach to Decision Making Can Help You Lead Teams Better Room 15AB #266: Electronic Systems: Are Yours Fit for Purpose? Room 17AB #267: Translating Academic Research Into Product Development: The What and Why of cGMP in Translational Science (Part 2 of 4) Room 11B #268: Current Status of FDA Framework for the Evaluation of Real World Evidence Room 6B #269: Driving Complex Generics to Approval: What are the Keys to Success Room 6F #270: Where Quality Meets Safety and Efficacy: An Interactive Experience Room 8 #271: Master Protocols: Applications in Oncology Room 3 #272: Aligning Facilitated Regulatory and Access Pathways: Observations from the North American Experience Room 14B #273: Presentations as Listeners Like Them: How to Tailor Messaging Room 14A

3:15pm

3:30pm

4:15pm

#299.1 CH: Challenge of Regulatory Starting Material Designation and Its Implication on the Global Markets for the Post Approval Process Content Hub Sails Pav Community Meet Up: Member Networking and Making the Most of your Membership Community Area Sails Pav #281: Structured Evidence Planning, Production, and Evaluation (SEPPE): A “Quality-Based” Framework for Drug Development Room 6C #282: The Elephant in the Room: Meaningful Communication of Near Synonyms as Suspected Adverse Reactions Room 6D #283: Let's Talk Risk-Based Monitoring Room 9 #284: Virtual Clinical Trials Room 10 #285: Using Mobile Sensors in Clinical Trials and Evidentiary Considerations for Electronic Submissions Room 11A #286: The Machines are Here! Learn About Real Uses of Machine Learning and Artificial Intelligence in Pharma Room 1AB #287: A Case Study in Structuring Clinical Content and Structured Content Management (SCM) Room 4 #288: The Changing Landscape of Medical Affairs: Are We Prepared For 2020? Room 11B #289: Impact of Patient Engagement on the Biopharmaceutical Industry's Business and Organization Room 5AB #290: The Responsibility Industry, Agencies, and Early Education own in Cure-Model Based Therapeutics Room 16AB #292: Conversations with the Participant: Layperson Summaries and Return of Results Room 15AB #293: Real World Evidence: How Does its Use Challenge Quality and Compliance Programs? Room 17AB #295: Prescription Drug Labeling: New Guidances from the US FDA Room 6B #296: Informing Development and Authorizations Using Real World Evidence/Artificial Intelligence Room 6E #294: Update From the US FDA on Progress and Topics of Current Interest in US Biosimilar Policy, Regulation, and Outreach/Education Room 6F #297: Integration of Manufacturing Quality Assessment and Pre-Approval Inspections Room 8 #298: Clinical Safety Assessment: What’s a Statistician Got to Do with It? Room 3 #299: Public and Regulatory Response To Drug Pricing Concerns Room 14B

5:00pm