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Saturday, June 22
 

8:00am

 
Sunday, June 23
 

8:00am

9:00am

11:00am

12:30pm

12:45pm

1:30pm

2:30pm

3:45pm

 
Monday, June 24
 

7:00am

8:00am

10:00am

10:10am

10:15am

11:00am

#105: Addressing Heterogeneity of Real World Evidence in Drug Safety Room 6D #106: Moving Forward in EU Pharmacovigilance Room 6C #107: Emerging Technologies in Clinical Research Room 11A #108: Innovation in Enrollment, Recruitment, and Retention Room 9 #109: When Disaster Strikes: Developing a Proactive Plan to Address Challenges Brought on by Large Scale Natural Disasters Room 10 #110: Automation with Intelligence: Transformation From Human Resource to Artificial Intelligence in Risk Management Room 1AB #111: PhactMI Benchmarking Survey Highlights: How are the Twenty Seven Member Companies Executing on Medical Information Initiatives Room 4 #112: Collecting Better Patient Experience Data: Lessons Learned from Patient Organizations Room 5AB #113: Artificial Intelligence in Drug Discovery and Development: Emerging Technologies and Applications Room 2 #114: Patient Perspective Diversity: Taking Cultural Differences in Patient Views Into Consideration in US, EU, and Japan Room 15AB #115: Quality Management Post-Quality Management System Implementation In The Wake of ICH E6 (R2) Room 17AB #116: Harnessing Power of Advanced Technologies for Digital Transformation in Regulatory Affairs Room 6F #117: International Regulatory Convergence Room 6B #118: Statistical Considerations for Trials Using Surrogate Endpoints for Accelerated Approval Room 3 #119: Making Value-Based Contracting Stick Room 11B #120: FDA Payer Communication Guidance, Twenty Years in the Making: Now What? Room 14B #121: Emerging Professionals: Making the Most of Your Networking Experience at the DIA Global Annual Meeting Room 14A

12:00pm

12:15pm

12:30pm

1:00pm

1:15pm

1:30pm

1:45pm

2:15pm

#135: Using Real World Data to Develop a Safety Monitoring Program and Ensure Pre- and Post-Market Continuity Room 6D #136: Interpretation of New Pharmacovigilance Regulations: Key Insights Room 6C #137: Emerging Technology to Improve Sponsor-Site Interactions Room 11A #138: Blockchain in Clinical Trials Demo: Truth or Dare Room 9 #139: Developing Standard Core Clinical Outcome Assessments and Endpoints: FDA Perspective and Plans Room 10 #140: Use of Real World Data in Clinical Trials: Abstracting Endpoints from Encounters Room 1AB #141: Knowledge Management and Information Sharing to Support Business Continuity Room 4 #142: Show Me the Money! Patient and Caregiver Roles and Compensation in Research, Development, and Innovation Room 5AB #143: Opportunities and Challenges with First-In-Human Multiple Expansion Cohort Designs in Oncology Room 2 #144: Ready or Not: Business Continuity Planning Room 15AB #145: Examining Essential Elements of Vendor Governance and Comparing Perspectives of Large and Emerging Biopharma Room 17AB #146: Communications with Regulators Beyond Formal Meetings Room 6B #147: Update from Health Canada: The Health Protection Branch Room 6F #148: Hot Topics in Digital Health: How is FDA’s Approach Evolving, and What Do Industry and Patients Need to Know? Room 6E #149: Hype Versus Reality: Artificial Intelligence and Drug Development Room 11B #150: TFDA Town Hall: Focus on Regenerative Medicine Room 14B #151: Update on ICH Quality Topics Room 8 #152: Making Data Meaningful: Using Data Visualization to Drive Efficiency in Safety Analysis Room 3 #153: How Storytelling, Images, and Engagement Can Wow Your Audience: Presentations with Punch! Room 14A

3:30pm

#154: Current Initiatives on Patient Involvement in the Medicinal Product Lifecycle: CIOMS XI Room 6C #155: Incorporating Systems-Theory and Human Factors into the Investigations of Serious Harm in Clinical Research Room 6D #156: Clinical Research in Emerging Regions Room 9 #157: A Large Academic Medical Center’s Perspective on Using Precision Medicine to Find Patient Disease Subgroups at Scale Room 11A #158: Enhancing Patient-Focused Outcome Assessment in Medical Product Development Room 10 #159: Understanding the Data Journey In Virtual Trials Room 1AB #160: New Communication Channels for Medical Information Room 4 #161: Making Trials Work for Special Populations Room 5AB #162: Precision Medicines in Clinical Trials: Understanding and Overcoming Barriers to Adoption Room 2 #163: Strategic Integration: Is Anyone Getting it Right? Room 15AB #164: Compliance: The Importance of Periodic Screenings to Ensure Good Inspection Health Room 17AB #165: Drug Development Tools in a Digital Era Room 6F #166: Updates on China Regulatory Reform Room 6E #167: Strategic Priorities of the International Coalition of Medicines Regulatory Authorities in an Increasingly Globalized Industry Room 6B #168: Regulating Innovation in Chemistry, Manufacturing, and Controls: Challenges and Opportunities Room 8 #169: How Statistics Can Help Improve Data Quality: ICH E6 R2 Room 3 #170: Making Early Access for Patients Happen Room 14B #171: The Courage of Career Transitions Room 14A #172 CH: Paving the Path for Family-Centered Design: Caregiver Roles in Medical Product Development Content Hub Sails Pav Community Meet Up: Forum of Pharmacovigilance Quality Heads Community Area Sails Pav

4:30pm

4:45pm

5:15pm

5:30pm

6:00pm

 
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

 
Wednesday, June 26
 

7:00am

7:30am

8:00am

#302: Triple-s (3S) Smart Safety Surveillance Room 6D #301: So Much Data, So Little Time: Hot Topics in Benefit-Risk Assessment Room 6C #303: Disruptive Technology Transforming Clinical Trials: The Case for Artificial Intelligence, Blockchain, and Mobile Tech/Wearables Room 11A #304: Operationalizing Master Protocols Room 10 #305: Demystifying Technology Selection in Mobile Clinical Trials Room 9 #306: Methods for Integrating EHR Data into EDC and eSource Databases Room 1AB #307: Can Topic-Based Approaches to Document Authoring Help Meet the Demands of Accelerated Marketing Application Timelines? Room 4 #308: Identifying High-Value Patient Engagement Opportunities: A Collaborative Three-Step Process for Sponsors and Patient Groups Room 5AB #309: Neoantigen-Based Cancer Therapies: Regulatory Challenges and Opportunities Room 2 #310: Project Planning 101: Turning Strategy into Execution Room 15AB #311: Improving Trial Quality by Better Preparing Site Teams Room 17AB #312: Translating Academic Research into Product Development: The Importance of Understanding GLPs at an Early Stage (Part 3 of 4) Room 14A #314: Medical Devices: EU Medical Device Regulation, PMDA Updates, and US MDUFA IV – Where Are We Now? Room 6F #313: Model Integrated Evidence as Pivotal Information for Drug Regulatory Decision Making: When, Where, and Why Room 6E #315: Measuring and Assessing Product Manufacturing Quality Room 8 #316: Implementation of Innovative and Adaptive Designs in Clinical Trials Room 3 #317: Designing Clinical Trials with the Right Endpoints: Applying ICH-E9(R1) - Getting the Questions Right (GTQR),Estimands and Handling Missing Data Room 11B #319: How to Solve the Problem of Access for Rare Diseases Room 16AB #318: Opportunities and Challenges of Collecting Data in a Pre-Approval Access Setting: A Multi-Stakeholder Perspective Room 14B

9:00am

9:15am

9:30am

9:45am

10:00am

10:30am

#327: Digital Risk Minimization: The “Next Generation” Risk Management Tools Room 6C #328: Risk-Based Monitoring: Best Practice Today and Technology for Tomorrow Room 9 #329: Global Clinical Trials: Make Them Really Global and Involve Africa Room 10 #330: The Analytics Revolution: Opportunities and Threats for Disrupting Clinical Development Operations Room 11A #331: A Pharma/CRO Partnership in the Design and Execution of Paperless Clinical Trials from eICF to Database Lock Room 11B #332: eSource Adoption: Where We Are - Our Experiences from eSource Implementation Room 1AB #333: Pediatric Plans: The Challenges Between Regulations and Reality Room 4 #334: Understanding and Exploring Elements of a Patient-Focused Product Launch Room 5AB #335: Highlights of the Patient Engagement Preparedness, Capabilities, Experience, and Impact (PEPCEI) Study Room 14B #336: Exploring the Evolving Requirements for the Clinical Assessment of Abuse and Dependence Potential of CNS-Active Drugs Room 2 #337: Application of Project Management Methodologies and Tools in NonProfit Institutions Room 15AB #338: Expanding Use of Interactive Response Technologies in Clinical Trials: Maintaining Data Quality and Reliability Room 17AB #340: Digital Technology Advances Labeling Management and Patient Access Room 6F #341: The Evolving Gene Therapy Regulatory Framework: A Brave New World Room 6E #342: When is Real World Evidence Ready for Prime Time? Room 6D #339: Hot Topics in Quality and Regulatory Affairs for Combination Products Room 6B #343: Efficient Preparation of Global CMC Dossiers Room 8 #344: Meaningful Patient-Focused Drug Development for Rare Disease and Personalized Medicine Room 3 #345: Achieving High Performance Through Emotional Intelligence Room 14A DIAlogue Session 3: From My Crazy Career Path to Inside the Industry and How I Ended Up Here! Community Area Sails Pav

11:30am

11:40am

12:30pm

12:40pm

12:45pm

1:15pm

1:40pm

2:00pm

#373 CH: Success in the Workplace: What Does That Mean and How Can You Achieve it? Content Hub Sails Pav #374 EE: Enabling Patient-Centric Clinical Studies: TransCelerate’s Patient Engagement Tools E and E Area Exh Hall #375.1 RT: Round Table Discussion: The Elephant in the Room: Meaningful Communication of Near Synonyms as Suspected Adverse Reactions Community Area Sails Pav #375 RT: Round Table Discussion: Can Topic-Based Approaches to Document Authoring Help Meet the Demands of Accelerated Marketing Application Timelines? Community Zone Sails Pav #355: History of Risk Evaluation and Mitigation Strategies (REMS): What Have We Learned? Room 6C #356: Involving Patients in Medicinal Product Benefit-Risk Communication: How're We Doing? Room 6D #357: Accelerating Drug Development via Structured Content Reuse: Introducing the TransCelerate Clinical Template eSuite Room 11A #358: Improving the Trial Experience for Rare Disease Patients: Identifying and Overcoming Obstacles Room 9 #359: Training for the Electronic Capture of PRO Data in Clinical Trials: Views from ePRO Vendors, Sponsors, Sites, and Patients Room 10 #360: Identification of Medicinal Products: FDA's Perspective and Approach Room 1AB #361: Returning Plain Language Summaries to Research Participants: Best Practices and the Role of the IRB Room 4 #362: Patient Engagement Quality Guidance: Results and Learnings from Global Multistakeholder Pilots Room 5AB #363: Neurodegenerative Diseases: Early-Stage Challenges and Optimal Models in Drug Development Room 2 #364: Effective Portfolio Management of Assets Across an Organization Room 15AB #366: Translating Academic Research into Product Development: Integrating GCP Training into the Process (Part 4 of 4) Room 16AB #365: Leveraging Data Analytics to Drive Compliance and Quality in a Risk-Based Monitoring Environment Room 17AB #367: Model-Informed Drug Development (MIDD) and Complex Innovative Designs (CID) Programs: Where are We and What Have We Learned? Room 6B #368: Global Rare Disease Town Hall Room 6F #369: User-Fee Programs Myth Busting: General Financial Principles Explained Room 6E #370: Challenges and Opportunities in Product Quality: Lifecycle Management Room 8 #371: Efficient Pediatric Drug Development: Incorporating Innovative Techniques Using Extrapolation and Historical Information Room 3 #372: Advancing Value and Access With Technology Room 14B

3:15pm

3:30pm

4:15pm

#379: From Trials to Real World: How Safety Protocols Impact REMS Room 6C #381: A New Path Forward for Using Decentralized Clinical Trials Room 10 #380: Incorporating Patient Input into the Design and Conduct of Clinical Trials Room 9 #382: Real World Data Quality for Regulatory Decision-Making Room 1AB #383: Next-Generation Approaches for Developing Narratives Room 4 #384: Patient Preferences in Decision Making and the PREFER Project: Past, Present, and Future Room 5AB #385: The Importance of Human Translation for Successful Preclinical Drug Discovery and Cardiac Safety Room 2 #386: Setting the Stage for Effective Stakeholder Collaboration Room 15AB #387: Global Perspective on ICH E8(R1): General Considerations for Clinical Trials Room 17AB #388: Convergence of the Regulatory Pathways for Advanced Therapy Medicinal Products Room 6F #391: Real World Evidence and Artificial Intelligence to Inform Post-Authorization Studies Room 16AB #392: Breakthrough Therapy and PRIME Expedited Regulatory Pathways: Experience, Analysis, and Reflections from EMA, FDA, and Industry Room 6D #390: Clinical Trial Innovation: Pathways for Selecting and Developing Novel, Fit-for-Purpose, Technology-Derived Study Endpoints Room 6E #389: Transparency, Expanded Access Navigator, Right to Try: Helping Patients Get Access to Investigational Medicines? Room 6B #393: Case Studies in Resolving Quality Issues Room 8 #394: Demystifying Basic Statistical Concepts for Anyone Involved with Clinical Trials Room 11B #395: Utilization and Evaluation of Innovative Approaches for Efficient Drug Development Room 3 #396: Challenges to Access: Bringing Payers to the Table Room 14B #397: PowerUp: Stories of Career Transforming Moments Room 14A

4:30pm

 
Thursday, June 27
 

8:00am

8:30am

9:00am

10:45am