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Level: Intermediate [clear filter]
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Tuesday, June 26
 

8:00am

#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 #216: Early HTA Scientific Advice: Does it Improve Internal Company Decision-Making and Ensure Predictability of HTA Outcome? Room 258C

10:30am

12:00pm

1:15pm

1:30pm

2:00pm

4:15pm