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Type: 13: Community-Rounds clear filter
Monday, June 15
 

1:00pm EDT

#422 RT: Roundtable Discussion: Accelerating US Based Domestic Manufacturing by Leveraging Innovative Regulatory Concepts
Monday June 15, 2026 1:00pm - 2:00pm EDT
Component Type: Session
Level: Intermediate

Join the Regulatory Affairs Community for a follow up round table discussion tied to session: Accelerating US Based Domestic Manufacturing by Leveraging Innovative Regulatory Concepts (Monday, June 15 | 1:00pm - 2:00pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Jude Nwokike, MPH, MSC, RPH, RAC

Monday June 15, 2026 1:00pm - 2:00pm EDT
Zone B The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  13: Community-Rounds, Session

1:00pm EDT

#423 RT: Roundtable Discussion: Enhancing Regulatory Collaboration through Cloud Technologies
Monday June 15, 2026 1:00pm - 2:00pm EDT
Component Type: Session
Level: Intermediate

Join the AI in Healthcare Community for a follow up round table discussion tied to session: Enhancing Regulatory Collaboration through Cloud Technologies (Monday, June 15 | 1:00pm - 2:00pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Khushboo Sharma, MBA

Monday June 15, 2026 1:00pm - 2:00pm EDT
Zone A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  13: Community-Rounds, Session
 
Tuesday, June 16
 

12:30pm EDT

#526 RT: Roundtable Discussion: FDA Public Posting of Complete Response Letters: A Year in Review, Trends, and Impact Analysis
Tuesday June 16, 2026 12:30pm - 1:30pm EDT
Component Type: Session
Level: Intermediate

Join the Statistics & Data Science Community for a follow up round table discussion tied to session: FDA Public Posting of Complete Response Letters: A Year in Review, Trends, and Impact Analysis (Tuesday, June 16 | 12:30pm - 1:30pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Matthew Vankoski

Tuesday June 16, 2026 12:30pm - 1:30pm EDT
Zone A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  13: Community-Rounds, Session

3:15pm EDT

#544 RT: Roundtable Discussion: Is Your AI Ready to Scale? Build the Governance Backbone for Reliable Innovation and Trust
Tuesday June 16, 2026 3:15pm - 4:00pm EDT
Component Type: Session
Level: Intermediate

Join the AI in Healthcare Community for a follow up round table discussion tied to session: Is Your AI Ready to Scale? Build the Governance Backbone for Reliable Innovation and Trust (Tuesday, June 16 | 3:00pm - 4:00pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Atika Kumar, MBA, MS

Tuesday June 16, 2026 3:15pm - 4:00pm EDT
Zone B The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  13: Community-Rounds, Session

3:15pm EDT

#545 RT: Roundtable Discussion: Regulators Approach to Address Drug Shortages
Tuesday June 16, 2026 3:15pm - 4:00pm EDT
Component Type: Session
Level: Intermediate

Join the Regulatory Affairs Community for a follow up round table discussion tied to session: Regulators Approach to Address Drug Shortages (Tuesday, June 16 | 3:15pm - 4:00pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Allison Radwick

Tuesday June 16, 2026 3:15pm - 4:00pm EDT
Zone A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  13: Community-Rounds, Session
 
Wednesday, June 17
 

12:30pm EDT

#620 RT: Roundtable Discussion: Can You Complete Your Submission in 10 weeks?
Wednesday June 17, 2026 12:30pm - 1:30pm EDT
Component Type: Session
Level: Intermediate

Join the Medical Writing Community for a follow up round table discussion tied to session: Can You Complete Your Submission in 10 weeks? (Wednesday, June 17 | 12:30pm - 1:30pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Steve Sibley, MS
Sharon Wolfe-Schwartz, MS

Speakers
avatar for Steve Sibley

Steve Sibley

Vice President, Global Submissions and Submissions Leadership, Veristat LLC, United States
With a career spanning more than 30 years in the pharmaceutical industry, Mr. Sibley has extensive experience across regulatory writing, consulting, and regulatory project leadership roles. He has successfully supported projects from discovery through approval and life cycle management... Read More →
Wednesday June 17, 2026 12:30pm - 1:30pm EDT
Zone B The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  13: Community-Rounds, Session

12:30pm EDT

#621 RT: Roundtable Discussion: International Regulatory Cooperation with the African Medicines Agency
Wednesday June 17, 2026 12:30pm - 1:30pm EDT
Component Type: Session
Level: Intermediate

Join the Regulatory Affairs Community for a follow up round table discussion tied to session: International Regulatory Cooperation with the African Medicines Agency Wednesday, June 17 | 12:30pm -1:30pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Chaitanya Koduri, DDS, MHS

Wednesday June 17, 2026 12:30pm - 1:30pm EDT
Zone A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  13: Community-Rounds, Session

3:00pm EDT

#629.2 RT: Roundtable Discussion: Insights Regarding Implementation of the ASAP Process
Wednesday June 17, 2026 3:00pm - 3:45pm EDT
Component Type: Session
Level: Intermediate

Join the Clinical Safety and Pharmacovigilance Community for a follow up round table discussion tied to session: Insights Regarding Implementation of the ASAP Process (Wednesday, June 17 | 2:45pm - 3:45pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Greg Ball, PHD

Wednesday June 17, 2026 3:00pm - 3:45pm EDT
TBD The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  13: Community-Rounds, Session

3:00pm EDT

Roundtable Discussion: Building AI Governance Frameworks: Classification, Validation and Regulatory Alignment in Life Sciences
Wednesday June 17, 2026 3:00pm - 3:45pm EDT
Component Type: Session
Level: Intermediate

Join the AI in Healthcare Community for a follow up round table discussion tied to session: Building AI Governance Frameworks: Classification, Validation and Regulatory Alignment in Life Sciences (Wednesday, June 17 | 2:45pm - 3:45pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Sridevi Nagarajan, PHD

Speaker

Speaker
Stephanie Rosner, MA, PMP


Wednesday June 17, 2026 3:00pm - 3:45pm EDT
TBD The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  13: Community-Rounds, Session
 
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DIA 2026 Global Annual Meeting
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