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Sunday, June 24
 

8:30am

#21: The IDMP Challenge: Points to Consider for Pharmacovigilance Departments TBD #28: Preparing Documents for Disclosure and Public Sharing TBD

9:00am

#42: Back to the Future: Combination Products in the 21st Century TBD

10:30am

Emerging Professionals and Student Forum TBD

1:00pm

#35: FDA Advisory Committee Purpose and Noninferiority Case Study: Rivaroxaban TBD #37: Data Visualization in the Life Sciences TBD

3:00pm

Effective Use of Social Media TBD

4:15pm

The Power of Networking TBD
 
Monday, June 25
 

10:15am

#103: Networking Do's and Don'ts E and E Exhibit Hall

10:30am

#104: LinkedIn Review Content Hub Exhibit Hall

11:00am

#105: Cardiac Safety in Drug Development and the Critical Role of Public-Private Partnerships: The Cardiac Safety Research Consortium Model Room Room 253AB #107: The Metamorphosis of Clinical Trials: Evolving Roles of Stakeholders in Digital Trials Room 257AB #122: Contracting for Value: from Outcomes-based Contracts to Bundled Payment Programs: What’s Working and Why Room 252AB #113: Patient-Focused Medicines Development: Where It has Led Us to Today, What Challenges Remain, and What Do We Still Need to Do to Achieve Success? Room 151AB #120: FDA Innovation in Pharmaceutical Quality Assessment and Inspection Room 206AB #123: Unmet Medical Need: Diversity of Definitions and Viewpoints – Detangling the Challenge Room 157AB

12:30pm

#125: Organizational Change and Knowledge Management for Cybersecurity Threats E and E Exhibit Hall

3:00pm

#140: How Inspection Ready is your Organization? Room 253AB #151: Using Real World Evidence for Regulatory Support: Time to Embrace the Future Room 205AB
 
Tuesday, June 26
 

8:00am

#218: Building Your Brand Room 254AB

9:15am

#219: FDA Warning Letters on Data Integrity Content Hub Exhibit Hall

9:30am

#220: Brexit: Practical Real World Solution Planning E and E Exhibit Hall

10:00am

#225: Effective Presentations Content Hub Exhibit Hall

10:30am

#231: Automation with Intelligence: From Standard-Based Solution to Metadata-Driven Automation Room 209 #232: Digital Data and New Technologies to Drive Customer Impact in Medical Affairs, Medical Writing, and Medical Communications Room 210C

2:00pm

#261: Project Management Throwdown: How Not to Get Chopped Room 153ABC #266: User-Friendly Tools for Study Planning and Analysis Room 256

3:30pm

#273: DIA Insights: Expert Clinical and Regulatory Content - Timely Global and Regional Reports, New Digital Platform - Can We Help You? Content Hub Exhibit Hall #272: LinkedIn Profile Exchange Review E and E Exhibit Hall

4:15pm

#293: Medical Monitoring in Non-Interventional Studies: Need for Medical Leadership and Study Primary Care Management Room 257AB
 
Wednesday, June 27
 

8:00am

#321: PowerUp: Career Transforming Moments Community Zone NE Lobby #304: Data and Quality Approaches to Informing Global Investigative Site Selection Room 258AB #307: Maintaining Patient Engagement in the Development of Patient-Reported Outcome (PRO) Measures Room 153ABC #308: How Do Patients and Other Multi-Disciplinary Stakeholders Collaborate to Develop Patient Registries which Accelerate Research? Room 151AB

10:00am

#328: Getting the Questions Right Content Hub Exhibit Hall

10:30am

#330: Artificial Intelligence: Robots Taking Over Clinical Research Room 253C #342: Sex Considerations in the FDA Drug Review Pipeline: The Where, When, and How Room 205C

1:15pm

#356: The Worst Co-Worker on the Block E and E Exhibit Hall

1:30pm

#357: Difficult Conversations Content Hub Exhibit Hall

2:00pm

#359: IMEDS: A Collaboration Based on the FDA's Sentinel Initiative Room 253C #365: Engaging the Rare Disease Community to Design Clinical Trials Room 151AB #366: Gene Therapy Clinical Trials: Current Challenges Room 156ABC #367: Real Life Strategies for Collaborative Stakeholder Management Room 252AB #374: Modernization and Harmonization of Inspectional Approaches Room 208 #376: Courageous Hiring Room 254AB

4:00pm

#392: FUNdamentals of Project Management Room 153ABC
 
Thursday, June 28
 

8:30am

#403: General Data Protection Regulation (GDPR): Impact, Self-Assessment, and Practical Solutions for Compliance Content Hub Exhibit Hall

9:00am

#404: Payers, Industry, and Academia Collaborating on Post-Marketing Surveillance Room 204AB #405: Putting Patient Experience First Room 205AB #412: Metrics and Meaning: Evolving Metrics in Generic Drug Application Review and Communications to Improve ANDA Submission Planning and Approvability Room 257AB