Loading…
Simple
Expanded
Grid
By Venue
Type: 08: RD Quality-Compliance [clear filter]
Wednesday, June 15
 

10:00am CDT

32A: R&D QA Comprehensive Quality Strategy: An Approach to Managing Quality Risks throughout the Drug Development Lifecycle Virtual
 
Monday, June 20
 

1:15pm CDT

#109: Risk-Based Monitoring in Clinical Trials: An Evolution of Practices During the COVID Pandemic Room 176

1:30pm CDT

#114: Data Integrity Across the Product Lifecycle Room 183 B

4:00pm CDT

#138: ICH E8(R1): Regulators' Perspectives on Quality-by-Design of Clinical Studies Room 185 AB
 
Tuesday, June 21
 

9:15am CDT

#211: Shifting the Audit Paradigm for a More Effective Outcome Room 186

11:00am CDT

#221: Complying with the EU-CTR Disclosure Standards in the Era of GDPR Room 470 B

2:00pm CDT

#251: Data Science, Text Analytics, and Machine Learning to Derive Insights from Clinical Quality, Compliance, and Real-World Data Room 183 B

3:00pm CDT

#256 RT: Round Table Discussion: Technology-Enabled Clinical Trials Using Electronic Health Record (EHR)-Derived Real-World Data: Opportunities and Limitations Room 375 A Zone 1

4:15pm CDT

#273: IMPALA (IntercoMPany quALity Analytics) Industry Group: Data Science Development and Other Collaboration Updates Room 470 B
 
Wednesday, June 22
 

9:15am CDT

#309: Pharmacovigilance Quality: Key Considerations Room 187

11:00am CDT

#320: De-Risking Decentralized: Understanding the Dimensions of Risk and Maximizing Data Quality in Decentralized Trials Room 176

11:15am CDT

#327: New Approaches to Inspections Room 185 AB

1:45pm CDT

#343: Redefining the Value Proposition for Innovation: Connecting Data, Technology, and Quality to Improve Outcomes Room 179

2:00pm CDT

#350: The Transformation of Quality Assurance: The Roadmap Room 185 CD

4:15pm CDT

#373: Effective Oversight Strategies of CROs and Digital Technology Vendors: How to Comply with Health Authority Expectations Room 183 B
 
Thursday, June 23
 

10:00am CDT

#409: How to Build and Support a Culture that Values Critical Thinking and Open, Proactive Dialogue About Quality Room 185 AB
 
Monday, June 26
 

10:45am CDT

ICH E6 R3 Forum: Highlights of What's new and What Changed Regarding Sponsor Responsibilities TBD

1:30pm CDT

Unleashing the Fearless Quality Professional TBD

4:15pm CDT

One Year On: How Quality Briefs are Transforming the Approach to Quality and Driving Innovation to Serve Patients TBD
 
Tuesday, June 27
 

10:30am CDT

IMPALA (IntercoMPany quALity Analytics) Industry Consortium: Quality Analytics Use Cases and Early Health Authority Feedback TBD

1:15pm CDT

Pharmacovigilance: Regulator's Perspectives on Quality Approaches to Additional Risk-Minimization Measures and Post-Pandemic Inspection Reflections TBD

4:00pm CDT

Data Analytics for Quality Assurance: Shifting the Paradigm from Issue Detection to Quality Evidence Generation TBD
 
Wednesday, June 28
 

10:30am CDT

PI 1572 Responsibility and Oversight in Decentralized Clinical Trials TBD

1:15pm CDT

Industry and Regulators’ Experience with the Implementation and Use of Remote Consent TBD

4:00pm CDT

Quality by Design for Real-World Evidence Studies TBD
 
Filter sessions
Apply filters to sessions.
Filtered by Type (08: RD Quality-Compliance) - 
Clear filter
Monday, June 13
Tuesday, June 14
Wednesday, June 15
Thursday, June 16
Monday, June 20
Tuesday, June 21
Wednesday, June 22
Thursday, June 23
Monday, June 12
Tuesday, June 13
Wednesday, June 14
Monday, June 26
Tuesday, June 27
Wednesday, June 28
Thursday, June 29
Exh Hall Community Area
Exhibit Hall
Exhibit Hall Booth #1719
Exhibit Hall Theater #1
Exhibit Hall Theater #2
Exhibit Hall Theater #3
Level 3 F2 Entrance
Meeting Rm Lobby Level 1
Meeting Room Lobby
Room 175
Room 176
Room 178
Room 179
Room 180
Room 183 A
Room 183 B
Room 183 C
Room 184
Room 185 AB
Room 185 CD
Room 186
Room 187
Room 375 A Zone 1
Room 375 A Zone 2
Room 470 A
Room 470 B
Room 471 A
Room Skyline 375 CDE
Skyline Ballroom Foyer
TBD
Virtual
  • 00: Plenary
  • 01 - Clinical Safety and Pharmacovigilance
  • 01: ClinSafety-PV
  • 02: ClinTrials -ClinOps
  • 03: Data-Tech in Clinical Trials
  • 04: MedAffairs-SciComm
  • 05: Patient Engagement
  • 06: PreClinical Dev-EarlyPhaseCR
  • 06 - Translational Sciences and Precision Medicine
  • 06: TranslationalScience-PrecisionMedicine
  • 07: ProjectManagement-StrategicPlanning
  • 08: RD Quality-Compliance
  • 09: Regulatory
  • 10: RegCMC-Product Quality
  • 11: Statistics
  • 12: Value-Access
  • 13: ProfDevelopment
  • 14: DIAmond
  • 15: Content Hubs
  • 16: Community Rounds
  • 17: Networking Opportunities
  • 18: Posters
  • 19: InnovationTheaters
  • 20: Short Courses
  • Level
  • Advanced
  • Basic
  • Intermediate
  • Featured Topics
  • AI and Machine Learning
  • COVID-19
  • Data Science
  • Decentralized Trials
  • Digital
  • Diversity Equity and Inclusion
  • Innovative Trial Design
  • Patient Perspective
  • Personalized Health Care
  • Regulator Perspective
  • Remote Work
  • RWD-RWE
  • Special Populations
  • Student Programming