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Type: 10: RegCMC-Product Quality [clear filter]
Monday, June 20
 

1:15pm CDT

#112: ICH Q2 (R2) and Q14: Can We Realize the Vision for Risk-Based Approvals of Analytical Procedures and Changes? Room 180

4:00pm CDT

#142: The Future of CMC Regulatory Submissions: Streamlining Activities Using Structured Content and Data Management Room 180
 
Tuesday, June 21
 

9:15am CDT

#215: Efforts Toward Global Convergence of CMC and GMP Expectations Room 183 A

4:15pm CDT

#276: Rethinking Fundamental ICH CMC Guidelines: Analytical Procedures, Stability, Specifications, and Risk Assessment Room 176
 
Wednesday, June 22
 

11:00am CDT

#323: Remote GMP Assessments, Inspections and Audits : Here to Stay? Room 186

2:00pm CDT

#353: Planning for the Worst: Approaches for Drug Shortage Avoidance Room 183 B

3:00pm CDT

#356 RT: Round Table Discussion: Planning for the Worst: Approaches for Drug Shortage Avoidance Room 375 A Zone 2

4:15pm CDT

#376: How to Manage Device Design Changes Under EU MDR Room 183 C
 
Monday, June 26
 

1:30pm CDT

International Collaboration for Pharmaceutical Quality and Manufacturing Agility TBD

4:15pm CDT

Challenges in Analytical Development of Cell and Gene Therapy Products, Regulatory Perspectives, and Convergence TBD
 
Tuesday, June 27
 

8:30am CDT

Office of Generic Drugs/Office of Pharmaceutical Quality Town Hall TBD

1:15pm CDT

One Dossier and One Timeline for a Post Approval Change: The Story of a Regulatory Reliance Pilot! TBD

4:00pm CDT

Quality Aspects of FY23-28 User Fee Agreements TBD
 
Wednesday, June 28
 

10:30am CDT

Reliance in Action: How to Ensure Product Sameness When Using Global Supply Chains TBD

1:15pm CDT

Evolving Global Landscape for Addressing Drug Shortages: Innovative Strategies in the Area of Regulatory and Technology TBD

4:00pm CDT

Patient and Quality Impacts of Restrictions on the Use of Titanium Dioxide (TiO2) in Medicines TBD
 
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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
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  • 13: ProfDevelopment
  • 14: DIAmond
  • 15: Content Hubs
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  • 20 - Short Courses
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