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avatar for Kala Patel

Kala Patel

Akros Pharma Inc.
Sr. Director, Regulatory Affairs
Princeton, NJ
I have more than 20 years of experience in various areas of Regulatory Affairs. I am currently working in drug development of small molecule entities.
Monday, June 19
 

8:30am CDT

#101: Drug Repurposing: Where Will it Take Us? S105

10:00am CDT

Coffee Break TBA

11:00am CDT

#111: Patient Engagement: 4 W's and an H N426a #118: Counting on Safety S401d #120: FDA Rare Disease Town Hall N227b

12:00pm CDT

Luncheon TBA

12:30pm CDT

#132: QuintilesIMS Innovation Theater: The Next Generation of Clinical Development is Here Theater #2

3:00pm CDT

#142: Opening Remarks and Keynote Address Arie Crown Theater

4:45pm CDT

#143: Advanced Clinical Innovation Theater: Avoid Systems Overload: Connecting and Operationalizing Disparate Technology Systems Supporting Clinical Trials Theater #1
 
Tuesday, June 20
 

7:00am CDT

Coffee and Light Refreshments TBA

8:00am CDT

#202: People Will Talk: Gathering Insights from Digital Listening S100c

9:30am CDT

Coffee Break TBA #204: Effective Team Management in Global Trials Exhibit Hall

9:45am CDT

#206: Covance Innovation Theater: Overcoming Study Complexity Through Data-Driven Design Theater #2

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

11:30am CDT

Luncheon TBA

12:00pm CDT

DIA Communities Luncheon N427bc

12:45pm CDT

#237: Strategies for Communicating with FDA Exhibit Hall

1:00pm CDT

#239A: BioClinica Innovation Theater: Case Studies: How Companies Are Finally Reaping the Benefits of Risk-Based Monitoring. Theater #2

2:00pm CDT

#241: FDA Session: Electronic Submissions and Data N228 #251: Defining the Science of Patient Input to Enhance Drug Development and Approval: Regulatory N226

3:00pm CDT

Refreshment Break TBA

3:25pm CDT

#267: Veeva Systems, Inc. Innovation Theater: Unified RIM: End-to-end Submissions Development—from Planning Through Archival Theater #1

4:00pm CDT

#276: Defining the Science of Patient Input to Enhance Drug Development and Approval: Tools S402ab #284: Use of Novel Trial Designs to Accelerate Decision Making: To 'P' No More S401a
 
Wednesday, June 21
 

7:00am CDT

Coffee and Light Refreshments TBA

8:00am CDT

#303: International Regulatory Convergence S100a

9:30am CDT

Coffee Break TBA

10:30am CDT

#321: Engagement, Education, Networks, Media, and Societies in Rare Diseases: The MUST Haves S503ab #327: Multiregional Clinical Trials and the ICH E17 S402ab

11:30am CDT

Luncheon TBA

1:00pm CDT

DIA Regulatory Affairs Community, Regulatory Intelligence WG Round Table Discussion: The Evolving Role of Using Artificial Intelligence to Deliver Actionable Intelligence Community Corner

2:00pm CDT

#350: Innovative Designs and Statistical Approaches for Small Trials: Rare Disease or Pediatric Indications S502ab #352: Collaborative Efforts to Accelerate Rare Disease Research and Development S504abc

3:00pm CDT

Refreshment Break TBA

4:00pm CDT

#376: Changing Environments Within Pharmacovigilance S404d