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Sunday, June 14
 

9:00am

10:00am

1:30pm

2:30pm

3:45pm

 
Monday, June 15
 

8:00am

10:00am

10:10am

10:15am

11:00am

Benefit-Risk Management: Assessing Risk Evaluation and Mitigation Strategies (REMS) TBD Clinical Trials in a Digital Age: A Modern Approach to an Outdated Model TBD Conducting Successful Clinical Trials in China TBD Pediatric Clinical Trial Design and Ethical Considerations: Understanding Prospect of Direct Benefit and Risk TBD Deploying Machine Learning in Data Management TBD It Takes a Village to Write a Briefing Document: Working with Cross-Functional Team Members to Author Briefing Documents TBD Patient-Centricity: How Do We Talk to and Listen to Patients? TBD Patients First! How FDA is Making Patients a Priority TBD Bridging Bench to Bedside With Novel Biomarkers TBD From Biomarkers to Endpoints to Outcomes: The Regulatory Journey of Generating Clinical Significance TBD The Art and Science of Conflict Management for the Project Manager TBD Application of Real World Data and Analytics in Clinical Trial Design: Hype or Hope TBD Culture of Quality TBD FDA Guidance on Benefit-Risk Assessment for Human Drug Review TBD Is Your App a Drug, a Device or Something Else Entirely? TBD Strengthening Food and Drug Regulatory Systems Abroad: Recommendations from the FDA-Commissioned NASEM Report TBD International Convergence on Regulatory Review and HTA: Getting the “Universal Evidence” We Need for Decisions on Innovation TBD Gene Therapy Manufacturing: How Can Innovation Help Overcome This Anticipated Hurdle? TBD Best Practices for Randomization and Re-Randomization in Clinical Trials TBD Replication of Randomized Controlled Trials Using Real World Data: What Does Good Look Like? TBD CAR-T Therapies: Changing the Game TBD

12:15pm

1:00pm

1:15pm

1:45pm

2:15pm

Ensuring Clinical Safety and Pharmacovigilance Surveillance for Generic Drug Products TBD Advances in Safety Data Collection, Analysis, and Interpretation: A Regulatory and Industry Perspective TBD Novel Approaches to Study Prevalent Chronic Diseases as Alternatives to Large-Scale Clinical Trials TBD Older People Can’t Use ePRO and Other Industry Myths: An Interactive Debate TBD Quantifying the Time, Cost and Resource Requirements to Support the Vendor Qualification Process TBD The Changing Role of the Data Professional TBD Getting Real About Data Sharing for Drug Development and Drug Safety: The Real Reasons we Don’t Share Data and How to Motivate Change TBD Lean Writing: Making Regulatory Documents Simple and Straightforward TBD How Medical and Health Economics Data is Generated and Disseminated to Various Customer Segments TBD Global Commission Harnessing Cutting-Edge Technology to Accelerate Diagnosis of Rare Diseases in Children TBD Incorporating Patient Input into Medical Product Development and the US Food and Drug Administration’s Decision-Making TBD Phase 1 Cell and Gene Therapy Research: Special Considerations for CMC, Regulatory Approvals, and Site Preparation TBD Increasing Data Quality to Drive Strategic Decision Making and Portfolio Prioritization TBD Benchmarking and Identifying Opportunities to Improve Intentional Dose Non-Adherence in Clinical Trials TBD The Use of Quality Tolerance Limits in the Detection of Anomalies in Adverse Events Reporting TBD Accelerated Approval and Emerging Surrogate Endpoints TBD How to Engage with EMA Early in Development? Opportunities Including Innovation Task Force, PRIME, Scientific Advice TBD ICH 30th Anniversary: Achievements and Future Prospects TBD Using Artificial Intelligence to Inform Regulatory and Development Strategies TBD Quality Considerations for Complex Drugs TBD Clinically Meaningful: How is it Different from Statistical Significance? TBD Varying Perspectives on HTA in the US TBD Pebbles in your Mouth: Mastering the Art of Speaking Clearly TBD

3:45pm

Data Mining and Artificial Intelligence: The Present and Future for Safety TBD To Shape the Future of Patient Labeling Across Regions TBD Faster, Better, Cheaper: The Changing Role of Real World Data in Drug Development TBD Understanding Why Trial Master Files Fail Inspections: Steps You Can Take to Maintain Inspection Readiness TBD A Deep-Dive into Successful Instances of Patient-Facing Digital Technology Implementation and the Tools Behind Their Success TBD Data Strategy and Privacy Compliance in the Age of Digital Health: GDPR, HIPAA, and CCPA Implications TBD Virtual Clinical Trials TBD Online Medical Information Resources and Channels TBD Storyboarding for Key Message Alignment in Marketing Applications TBD Three FDA CBER-Sponsored Quantitative Patient Preference Studies of Biologic Treatments to Inform Regulatory Decision Making TBD Developing Products by the FDA Animal Rule: Working with FDA and Real World Challenges TBD Key Success Factors and Best Practices in Governance Meetings TBD Detection of Anomalies in eCOA Data and Metadata for More Pre-Emptive, Evidence-Based Risk Management TBD Clinical Safety: Approaches to Assure Compliance in the Pharmacovigilance and GCP Interface TBD Strategic Directions from Global Medicines Regulators: the ICMRA Statement on Combatting Antimicrobial Resistance TBD Utilizing Cloud-Based Platforms in Regulatory Contexts TBD Can We Avoid Unnecessary Studies in Vulnerable Pediatric Patients with New Players and Demands Coming from Outside US and EU? TBD Opportunities for Global Harmonization: Implementation and Interpretation of ICH TBD Defining the Treatment Effect of Interest in Regulatory Submissions: Estimands and ICH E9R1 Final Guidance TBD Hype or Hope: Quantifying the Genetic Risk of Patients with Complex Diseases TBD Communicating Value to Payers Pre-Approval in the US TBD Trust: What Makes It: What Breaks It TBD

5:00pm

5:15pm

 
Tuesday, June 16
 

8:00am

Advancing Risk Management: What Can Evidence-Based Practices to Disseminate Healthcare Evidence into Practice Teach Us? TBD Patient-Centricity: How do We Measure Progress in Involving Patients in Drug Development and Drug Safety? TBD The Opioid Epidemic: Top Ten Lessons in Regulatory Science TBD Global Clinical Trials in 2020 : Case Studies From India, Japan, and Africa TBD How Do You Oversee and Manage New Centralized/Remote/Site Monitoring Models? What Should you Measure to Gain Insights? TBD Templates That Do More: How We Are Accelerating Drug Development via Structured Content Reuse TBD How to Drive Insights From Real World Data TBD Artificial Intelligence in Medical Writing: Creation, Implementation, and Assessment TBD Build-a-Bot Workshop: Design and Build Your Own Digital MSL TBD Impact Patient Centered Initiatives in Clinical Trial Design and Execution TBD Patient Engagement in Plain Language Summaries (PLS) of Publications: Co-Creation Principles and Best Practices TBD Microbiome Therapies Beyond Fecal Microbiota Transplantation: Challenges and Opportunities TBD Leading through Complexity: Opportunities, Pitfalls, and Best Practices for Managing Successful Partnerships TBD Implementing Quality by Design for Clinical Trials: New Tools, Case Studies, and Multi-Stakeholder Discussion TBD Advancing Clinical Trial Innovation Through Model-Informed Drug Development TBD FDA-PAHO: Landscape Report of Regulatory Situation in the Americas TBD Generic Drug/Office of Pharmaceutical Quality Town Hall TBD Supporting Quality/CMC Development in Early Access Approaches Such as PRIME, Breakthrough Designation, and Other Programs with a Sense of Urgency TBD Utilizing Data Science to Enhance Clinical Trials TBD Considerations for Long-Term Outcomes Data Collection for Value-Based Payment Arrangements TBD Outcomes as a Pathway to Value and Pharma, Payer, Provider Collaboration TBD Mindfulness: Beyond Meditation TBD Unicorns or Zebras: Hiring Practices to Build Talent and Find the Perfect Candidate TBD

9:00am

9:15am

9:30am

9:45am

10:00am

10:30am

Assuring Access to Safe Medicines in Pregnancy and Lactation: International Regulators Perspective TBD MedDRA® Labeling Groupings for Enhanced Communication of Safety Concepts: Cinderella’s Glass Slipper? TBD Unblinding The New Face of the Local Safety Officer TBD An Exploration of Effective Regulator Engagement Regarding the Use of Digital Endpoints TBD Non-Traditional Clinical Trials Require a Non-Traditional Workforce TBD Operationalizing an Adolescent Virtual Trial: The Good, the Bad, and the Ugly TBD Advancing Clinical Research Through Fast Healthcare Interoperability Resources: An Industry Perspective of Where We Are and Where To Go TBD Wearables TBD Creating Stronger Marketing Application Dossiers Through a Thoughtful and Compelling Benefit-Risk Assessment TBD Seamlessly Evolving Global Clinical Trial Liaison Field Medical Resources to Classic MSLs from Phase 3 to Launch TBD The DEEP Model: Long-Term Commitment to Partnering With Patients TBD Immunogenicity Issues Related to CRISPR Cas-Mediated Gene Editing TBD Opioids: Approaches to Address Abuse Liability and Safety Concerns in Drug Development TBD Project Management Playbook to Effective Stakeholder Management TBD Leveraging an Artificial Intelligence Content Model to Drive Automation Across Clinical, Regulatory, and Safety Domains TBD Electronic Informed Consent: Global Perspectives TBD Health Canada Town Hall TBD NMPA Town Hall TBD Worldwide Advancement of ICH Quality Guidelines TBD Global Harmonization of Complex and Innovative Trial Designs TBD Keep Calm and Carry On: Mindfulness to Increase Work Productivity TBD

11:40am

11:45am

12:30pm

12:40pm

1:40pm

2:00pm

Value-Based Contracting in Action TBD FDA Pre-Market Safety Assessment Program TBD Practical Considerations for Robust Evaluation of Risk Minimization Programs: Regulatory, Industry, and Service Provider Insights TBD If You Build it, Will They Come? What’s Really Needed to Transform Information Flow in Clinical Development TBD The Rare Disease Clinical Outcome Assessment Consortium: Aiming to Fulfill Unmet Drug Development Endpoint Measurement Needs TBD Data Driven Monitoring Enabled Through Analytics and Quality Risk Management TBD FDA Data Standards Update TBD Balancing Clinical Trial Disclosure and Transparency With Global Data Protection Regulations TBD Globalization of Medical Information TBD Global Case Studies: Incorporating the Patient's Voice in Clinical Trial Design TBD Advancing Patient Engagement Preparedness, Capabilities, Experience, Impact: Learnings from the PEPCEI Study TBD Leveraging Clinical Pharmacology to Transform Real World Data into Real World Evidence for Special Patient Populations TBD Spectrum of Approaches for Innovative Project Management Methodologies TBD ICH 30th Anniversary Series: The Role of Efficacy Guidelines TBD Sponsor and Regulator Challenges, Risks and Mitigation Strategies for Ensuring Third-Party Oversight of Vendors: Is Your Study Data at Risk? TBD PMDA Town Hall: The Path of a New Chief Executive Since His Appointment TBD US Marketing Application Integrated Review: A View into FDA Internal Operations TBD What Makes Real World Data Trustworthy: A Focus on Design and Data TBD Demystifying Global Device Requirements: High Level Comparison of Current Expectations TBD The FDA Complex Innovative Trial Design Pilot Program: Case Examples TBD Just the Facts: Achieving Succinct Communications with Great Business Impact TBD

3:30pm

4:15pm

Engaging Patients to Support the Modernization of ClinicalTrials.gov TBD Harnessing a Transformative Zephyr to Guide the Safety Organization to Pharmacovigilance 2030 TBD What does THAT Mean? Communicating Study Risks and Benefits in Patient-Friendly Language TBD Optimizing Study Start Up Processes: Site Selection, Budgeting, and Contracting TBD Practical Solutions for Designing and Conducting a Digital Health Trial TBD Single-Sponsor Master Protocol: Development and Regulatory Experience with a Complex Innovative Design (CID) TBD Applying the Concepts of Good Clinical Practice in Real World Evidence TBD Clinical Electronic Structured Harmonized Protocol (CeSHarP): ICH M11 - Status Update TBD Best Practices in Developing Medical Information Responses TBD Development, Alignment, and Maintenance of Safety-Informing Regulatory Documentation TBD Global Rare Disease Town Hall TBD Patient Preferences in the Medical Product Lifecycle: Evolving Uses, Stakeholder Considerations, and Applications TBD Next Generation Analytics: Harnessing the Power of Nonclinical SEND Datasets to Improve Success in Early Clinical Development TBD Incorporating the Patient Perspective in a Drug Development Program TBD Case Studies with FDA and MHRA 2020 TBD Developing and Implementing Policy Across CDER’s Office of New Drugs and CBER TBD Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators TBD What are the Practical Regulatory Realities of Moving Towards Cloud-Based Submissions? TBD Knowledge-Aided Assessment and Structured Application (KASA) TBD Utilization of Bayesian Statistics in Clinical Trials TBD Drug Pricing in the United States: How and Why is it Different Than in the Rest of the World TBD Gaslighting at Work: How to Recognize and Respond to this Unique Form of Harassment TBD
 
Wednesday, June 17
 

8:00am

Patient-Focused Benefit-Risk Assessment and Risk Management: Methodology for Engaging With Patients - What Has Been Learned? TBD Report of CIOMS DILI Working Group TBD Artificial Intelligence In Clinical Research TBD Balancing Science, Regulation, and Social Good in Clinical Trial Participant Diversity TBD Evolving Trials for the Digital Age TBD Data Quality in Real World Evidence TBD Intelligent Machines Take on Clinical Data Management TBD A Project Management Mindset for Medical Writing TBD Engaging Caregivers in Research and Medical Product Development TBD Non-Profit Organizations Role in Accelerating Preclinical Compound Testing to Fuel the Rare Disease Clinical Pipeline TBD ICH 30th Anniversary Series: Advancing Pharmaceutical Safety TBD Approaches for Cross-Functional Teams to Enhancing Quality of Decision Making During the Development and Review of Medicines TBD Pharmacovigilance Inspections : Leveraging Inspections Readiness as a Driver of Quality in Your Organization TBD International Regulatory Approaches to Advanced Medicinal Products TBD Regulatory Issues for Complex Generics TBD Translating Frequently Collected Patient Experience Data into Meaningful Trial Endpoints TBD Sartan N-Nitrosamines Contamination Case Lessons Learned TBD Complex Innovative Designs for Confirmatory Clinical Trials: Platform Trials in the Confirmatory Setting TBD Dynamic Multi-Disciplinary Collaboration for Aggregate Product Safety Assessment and Benefit-Risk Planning TBD How to Achieve an Efficient Drug Development Program by Prioritizing Over Trial Options Incorporating Access Potential TBD Friendly Focused Feedback Fun TBD

9:00am

9:15am

9:30am

9:45am

10:00am

10:30am

Application and Validation of Intelligent Automation Technology in PV: Exploring Opportunities within the Individual ICSR Process TBD Digital Risk Minimization: How Can We Advance Adoption? TBD Unintended Immune Responses to Biologics: Clinical Consequences TBD Design and Implementation of Multiregional Clinical Trials (MRCT) Using ICH E17 Guidelines TBD The Opportunities and Challenges of Clinical Development in the Dynamic Regulatory Environment in China TBD Competition Versus Integration: Combining Multiple Real World Data Sources to Maximize Value and Opportunity TBD Data Quality TBD Tactics for Improving Document Quality TBD Telling Health Stories for Drug Development TBD Setting a Strategic Foundation for Mutually Beneficial Collaborations Between Industry and Patient Organizations TBD Patient Voice and Its Role In Bringing Meaningfulness into Selection of Clinical Outcome Measures TBD Recipe for Transformation to Higher-Performing Teams TBD Impact of Advanced Data Analytics Capabilities on Quality and Compliance Activities: Overview and Case Studies TBD Opportunities and Challenges for ICH E6 (GCP) Renovation TBD Have the Best Meeting with FDA! TBD Regulatory Barriers to Entry for Biosimilars TBD ICH 30th Anniversary Series: International Harmonization for Pharmaceutical Quality TBD Using Data Monitoring Strategies in Detection of Data Anomalies and Trial Misconduct TBD Paths from Approval to Coverage International Perspective TBD Real World Use of Real World Evidence TBD Project Management: Leading Teams with Emotional Intelligence TBD

12:30pm

1:15pm

2:00pm

Glass Half Full, Glass Half Empty, Job Half Done? TBD Evaluation of Safety Data and Analytics: The Case for an Impact-Based Approach to Signal Detection TBD ICH E2B IND Safety Reporting to FDA Adverse Event Reporting System (FAERS) TBD Examining Diversity in Clinical Trials TBD Journey of TMF Reference Model in Driving Inspection Readiness: The Decade's Impact, the Evolution to Come TBD Developing Standard Core Clinical Outcome Assessments and Endpoints: An Update on the FDA Pilot Grant Program TBD ICH 30th Anniversary Series: The Role of Multidisciplinary Topics TBD Assessing the Adoption of Clinical Trial Results Summary Disclosure to Patients and the Public TBD Incorporating Change Management into Medical Writing Process TBD Optimizing Communication with Patients to Support Meaningful Feedback into the Research Process TBD Qualitative, Quantitative, and Mixed Method Approaches to Capture the Patient Experience TBD Combination Therapies of Investigational Agents TBD Leadership Skills for Effective Project Management: Tapping That Leader in You TBD Driving Quality Through Innovative Approaches TBD Quality Oversight of Pharmacovigilance Processes TBD Catalyzing the Integration of Digital Therapeutics in Healthcare Solutions TBD Advanced Therapy Medicinal Products: Facilitating Individualized Gene Therapies and Cell-Based Therapeutics TBD EU-US Mutual Recognition Agreement: A Success Story TBD Opportunities and Challenges for Real World Data and Real World Evidence: Dive Into the Details TBD Subscription Models to Incentive Antimicrobial Innovation TBD Got Diversity: Get Inclusion! TBD

3:30pm

4:15pm

 
Thursday, June 18
 

8:00am

8:30am

9:00am

10:45am