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DC

Diane Cheng

Sunday, June 18
 

8:30am CDT

#21: Successful Drug Development: Best Practices for Drug Development Planning, Agency Interactions, and Regulatory Document Writing S401bc

1:00pm CDT

#30: Preparing for a US FDA Advisory Committee Meeting S401a
 
Monday, June 19
 

8:30am CDT

#102: The Evolution of Evidence Generation: Real-World Evidence and the Next Generation of Decision Making S100a

11:00am CDT

#120: FDA Rare Disease Town Hall N227b

1:15pm CDT

#135: PAREXEL International Innovation Theater: Developing Drugs in the New Era of Personalized Medicines Theater #1

3:00pm CDT

#142: Opening Remarks and Keynote Address Arie Crown Theater
 
Tuesday, June 20
 

10:30am CDT

#218: ClinicalTrials.gov: Complying with Requirements in the Final Rule (42 CFR Part 11) and Impacts of 21st Century Cures Act S404bc

2:00pm CDT

#258: Patient-Reported Outcomes (PROs): Hot Topics - Part 1 of 2 S404d

4:00pm CDT

#287: Patient-Reported Outcomes (PROs): Hot Topics - Part 2 of 2 S404d #291: Combination Products Exhibit Hall
 
Wednesday, June 21
 

10:30am CDT

#317: Evolution of Novel Registration Endpoints as Diseases Become Chronic S404bc

2:00pm CDT

#346: Understanding the New Common Rule and Its Impact to Industry N426b

4:00pm CDT

#367: Writing of Layperson Summaries of Clinical Trial Results According to the EU: Regulation and Its Impact on Global Pharmaceutical Activities S502ab
 
Thursday, June 22
 

9:00am CDT

#401: FDA Forum S105

10:45am CDT

#411: Evolving Clinical Trial Guidance and Regulations: Am I Ready? S405b