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Type: 01: ClinSafety-PV [clear filter]
Tuesday, June 14
 

2:00pm CDT

22P: Machine Learning in Pharmacovigilance Virtual
 
Wednesday, June 15
 

2:00pm CDT

33P: Presentation of Safety Risks Throughout the Product Lifecycle Framework: Key Findings and Practical Uses Virtual
 
Monday, June 20
 

1:15pm CDT

#108: Support of IND Safety Reporting by the Aggregate Safety Assessment Plan (ASAP) Room 175

2:30pm CDT

#124 RT: Round Table Discussion: Support of IND Safety Reporting by the Aggregate Safety Assessment Plan (ASAP) Room 375 A Zone 1

4:00pm CDT

#131: Innovations for Implementing REMS Room 185 CD #132: ICH E2D Update: Innovations in Collecting Safety Data from Disparate Sources Room 175 #139: FDA and EMA Benefit-Risk Assessments: Can We Optimize and Is There an Enhanced Role for Sponsors and Patient Preferences? Room 187
 
Tuesday, June 21
 

9:00am CDT

#202: Innovations in Risk Minimization: Methods, Tools, and Design Approaches Room 176 #201: Transforming PV at the MHRA Room 175

11:00am CDT

#219: Post-Approval Safety Studies: Approaches to Assessing Medication Exposure and Potential Safety Risks During Pregnancy Room 176

1:45pm CDT

#241: Drug Safety in Africa: New PV Horizons Room 178 #242: Risk Minimization for Health Products: What are we Learning for an Improved Path Forward Room 175

4:15pm CDT

#267: Improving Safety Data Through Innovative Use of Technology Room 175 #266: FDA's Updates on Ensuring Post Market Safety and Surveillance for Generic Drugs Room 178 #271: Building the First Cloud-Based Submission Review Collaboration Platform Room 184
 
Wednesday, June 22
 

9:00am CDT

#301: Uses of Artificial Intelligence for PV in the Context of COVID 19 Room 178

9:15am CDT

#309: Pharmacovigilance Quality: Key Considerations Room 187

11:00am CDT

#317: Let’s Make a PV Agreement: Four Solutions You Can Use to Enhance Your Entire PVA Process Room 175

1:45pm CDT

#340: Monitoring COVID-19 Vaccine Safety Room 178 #343: Redefining the Value Proposition for Innovation: Connecting Data, Technology, and Quality to Improve Outcomes Room 179

4:15pm CDT

#365: Field of Dreams: If We Build it, Will they Come? Using Implementation Science to Improve Digital Risk-Minimization Tools Room 175
 
Thursday, June 23
 

10:00am CDT

#404: Combination Product Safety: A Journey of Organizational Transformation Room 175 #412: Novel Visualization Tools for Safety Assessment: An Initiative Based on Multidisciplinary Collaboration Room 185 CD
 
Monday, June 26
 

10:45am CDT

Artificial Intelligence: Delivering on the Promise TBD Applying Implementation Science Methods to Generate Evidence to Improve Access to New Therapeutics: What has Been Learned? TBD

1:30pm CDT

Enhancing the Quality of Safety Data Collection TBD

4:15pm CDT

Utilizing Wearable Biosensors to Better Manage Patient Safety During Immuno-Oncology Studies TBD
 
Tuesday, June 27
 

8:30am CDT

Illuminating Risk Minimization Effectiveness Measurement TBD

10:30am CDT

Benefit-Risk Balance for Medicinal Products: CIOMS Working Group XII Report TBD

1:15pm CDT

Novel Methods for Signal Identification for Medicines and Medical Devices TBD

4:00pm CDT

Negotiating your Way Through the Vigilance Agreement Maze: Is There a Better Way? TBD Smarter Approaches to Pharmacovigilance Challenges TBD
 
Wednesday, June 28
 

8:30am CDT

Advancing PV in Africa TBD Using Real-World Data to Evaluate Safety Signals TBD

10:30am CDT

Opportunities to Improve Risk Minimization Outcomes with Behavioral Science TBD Registries Aren’t Always the Answer: Novel Designs for Executing Post-Market Pregnancy Requirements TBD

1:15pm CDT

Operationalizing FDA Medical Queries TBD

4:00pm CDT

Assessing Safety in Rare Disease Gene Therapy TBD
 
Thursday, June 29
 

8:30am CDT

Implementing the Program Safety Analysis Plan and Enhancing Ongoing Aggregate Review with an Interactive Open Sourced Tool TBD

9:45am CDT

Reporting of Pre- and Postmarket Safety Reports to FDA Adverse Event Reporting System (FAERS) Using ICH E2B Standards TBD
 
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Monday, June 13
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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