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Tuesday, June 18
 

11:00am PDT

#232 RT: Roundtable Discussion: Innovation in Manufacturing Globally
Component Type: Session

Join the Digital Acceleration/Regulatory Affairs/Statistics & Data Science Community for a follow up round table discussion tied to session: Innovation in Manufacturing Globally (Monday, June 17 | 2:15PM - 3:15PM PDT). Space is limited.

Chair

Brett Howard, JD, PhD

Speakers
avatar for Brett Howard

Brett Howard

Senior Director, US Regulatory Policy, USP, United States
Brett Howard is a Senior Director of US Regulatory Policy at the US Pharmacopeia, where he manages USP's regulatory efforts concerning pharmaceutical quality, covering both large and small molecules. Prior to joining USP, he spent the previous decade working for chemical and pharmaceutical... Read More →

Tuesday June 18, 2024 11:00am - 12:00pm PDT
Ballroom 20 A/ Zone 1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  16: Community Rounds, Session |   10: RegCMC-Product Quality, Session

2:15pm PDT

#257 RT: Roundtable Discussion: Good Data Governance Practices - Regulatory and Industry Perspectives
Component Type: Session

Join the Good Clinical Practices & QA Community for a follow up round table discussion tied to session: Good Data Governance Practices and the Importance of Incorporating Input from the Data Scientist in Quality by Design (Tuesday, June 18 | 8:00AM - 9:00AM PDT). Space is limited.

Chair

Terry Katz, MS

Speakers
avatar for Terry Katz

Terry Katz

Senior Director, Biostatistics and DM Planning and Functional Excellence, Daiichi Sankyo, United States
Terry Katz is Sr Dir of Biostatistics and DM Planning and Functional Excellence at Daiichi Sankyo. Previously he was Head of Global Data Management and Statistics at Merck Animal Health, Head of Biometrics at ImClone Systems, Senior Manager of Analysis & Reporting for PRA, and a Statistician... Read More →

Tuesday June 18, 2024 2:15pm - 3:15pm PDT
Ballroom 20 A/ Zone 1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  16: Community Rounds, Session |   08: RD Quality-Compliance, Session
 
Wednesday, June 19
 

11:00am PDT

#329 RT: Roundtable Discussion: The Evolving Role of Artificial Intelligence in the Medicinal Product Lifecycle
Component Type: Session

Join the Regulatory Affairs Community for a follow up round table discussion tied to session: The Evolving Role of Artificial Intelligence in the Medicinal Product Lifecycle (Tuesday, June 18 | 1:15PM - 2:15 PM PDT). Space is limited.

Chair

Brooke Casselberry, MS, RAC

Speakers
avatar for Brooke Casselberry

Brooke Casselberry

Vice President, Advisory and Delivery, Epista Life Sciences, United States
Brooke is known for her pivotal roles in collaborating with Sponsor Companies, Health Authorities, and Technology Developers. She has maintained focus on leveraging cutting-edge technologies as a catalyst for regulatory advancements, optimization, and collaboration for global go-to-market... Read More →

Wednesday June 19, 2024 11:00am - 12:00pm PDT
Ballroom 20 A/ Zone 1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  16: Community Rounds, Session |   03: Data-Tech, Session |   09: Regulatory, Session

2:15pm PDT

#356 RT: Roundtable Discussion: The Chatbot Will See You Now - Ethical Considerations in Incorporating AI in Informed Consent
Component Type: Session

Join the Bioethics Community for a follow up round table discussion tied to session: The Chatbot Will See You Now - Ethical Considerations in Incorporating AI in Informed Consent (Wednesday, June 19 | 10:00AM - 11:00AM PDT). Space is limited.

Chair

Karla Childers, MS

Speakers
avatar for Karla Childers

Karla Childers

Head, Bioethics-Based Science and Technology Policy, Johnson & Johnson, United States
Karla Childers is Head, Bioethics-based Science & Technology Policy in the Johnson & Johnson Office of the Chief Medical Officer. Her primary responsibility is leading and coordinating various bioethics-based, science policy projects since 2013. Her longest running responsibility... Read More →

Wednesday June 19, 2024 2:15pm - 3:15pm PDT
Ballroom 20 A/ Zone 1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  16: Community Rounds, Session |   05: Patient-Focused Drug Dev, Session
 
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Ballroom
Ballroom 20 A/ Zone 1
Ballroom 20 BC/ Zone 2
Ballroom 20 D/ Zone 3
Ballroom 20 Lobby
Ballroom 6 Lobby
Content Hub Sails Pav
Exhibit Hall
Exhibit Hall B 1
Exhibit Hall Theater #1
Exhibit Hall Theater #2
Exhibit Hall Theater #3
Posters Exhibit Hall
Room 11AB
Room 14AB
Room 15AB
Room 16AB
Room 17AB
Room 1AB
Room 2
Room 5AB
Room 6A
Room 6B
Room 6C
Room 6D
Room 6E
Room 6F
Room 7AB
Room 8
Sails Pavilion
TBD
USS Midway
  • 00: Plenary
  • 01: ClinSafety-PV
  • 02: ClinTrials -ClinOps
  • 03: Data-Tech
  • 04: MedAffairs-SciComm
  • 05: Patient-Focused Drug Dev
  • 06: TranslationalDelivery Tech-PrecMedicine
  • 07: ProjectManagement-StrategicPlanning
  • 08: RD Quality-Compliance
  • 09: Regulatory
  • 10: RegCMC-Product Quality
  • 11: Statistics-Data Science
  • 12: Value-Access
  • 13: ProfDevelopment
  • 14: DIAmond
  • 15: Content Hubs
  • 16: Community Rounds
  • 17: Networking Opportunities
  • 18: Posters
  • 19: InnovationTheaters
  • 20: Short Courses
  • Format
  • Forum
  • Session
  • Tutorial
  • Workshop
  • Level
  • Advanced
  • Basic
  • Intermediate
  • Featured Topics
  • Artificial Intelligence (AI)
  • Cell and Gene Therapy
  • Decentralized Clinical Trials (DCTs)
  • Digital Technology
  • Diversity Equity and Inclusion (DEI)
  • Ethics
  • ICH
  • Patient Focused
  • Rare Disease
  • Real-World Data (RWD)- Real-World Evidence (RWE)
  • Regulator Perspectives
  • Regulatory Collaboration
  • Regulatory Reliance
  • Risk Management
  • Special Populations
  • Student Programming