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MF

Melissa Figgins

Novartis
Group Quality External Engagement PMO
Colorado
Communication, Collaboration, Stakeholder Engagement, Project Management
Monday, June 19
 

6:30am CDT

CISCRP Medical Appreciation 5K TBA

7:00am CDT

Attendee, Speaker, and Exhibitor Registration TBA

7:30am CDT

Annual Meeting Orientation TBA

8:30am CDT

#102: The Evolution of Evidence Generation: Real-World Evidence and the Next Generation of Decision Making S100a

10:00am CDT

Coffee Break TBA

11:00am CDT

#115: Update from the CFDA S403ab #127: The Evolving International Landscape of FDA Inspections: Data Integrity Violations in Bioequivalence Studies in India S405a #128: Office of Pharmaceutical Quality Update: Innovative Approaches in Regulatory Assessment N230b

12:00pm CDT

Luncheon TBA

12:30pm CDT

#134: Student Poster Session and Oral Presentations 1A Exh Hall

1:15pm CDT

#135: PAREXEL International Innovation Theater: Developing Drugs in the New Era of Personalized Medicines Theater #1

3:00pm CDT

#142: Opening Remarks and Keynote Address Arie Crown Theater

4:30pm CDT

Opening Reception TBA

5:30pm CDT

#147: Appian Innovation Theater: Product Lifecycle Management In The Digital Era Theater #2
 
Tuesday, June 20
 

7:00am CDT

Coffee and Light Refreshments TBA

8:00am CDT

#201: Paying for Value in Biopharmaceuticals: Trends in the United States S105

9:30am CDT

Coffee Break TBA #205: Professional Poster Session 2A Exh Hall

10:30am CDT

#230: Global Harmonization: Mutual Recognition S402ab #231: A Risk-Based Approach to Quality Management for RWE Studies S400 Concourse

11:30am CDT

Luncheon TBA

12:00pm CDT

DIA Communities Luncheon N427bc

2:00pm CDT

#261: Comparison of Inspection Findings and Recommendations of Registration Trials Submitted in Support of Marketing Applications of New Drug Products to EMA and FDA N229 #262: Clinical Relevant Specifications: Leveraging Principles of QbD S401bc

3:00pm CDT

Refreshment Break TBA

4:00pm CDT

#290: Quality Metrics: The Carrot or the Stick? N229
 
Wednesday, June 21
 

7:00am CDT

Coffee and Light Refreshments TBA

8:00am CDT

#303: International Regulatory Convergence S100a

9:30am CDT

#305: Professional Poster Session 3A Exh Hall

10:30am CDT

#330: Managing Acceleration and Quality In Product Development S405b

11:30am CDT

Luncheon TBA

2:00pm CDT

#358: Life Cycle Management: ICH Q12 S404d

3:00pm CDT

Refreshment Break TBA

4:00pm CDT

#369: How Is Digital Patient Engagement Impacting Trial Participation? S404a
 
Thursday, June 22
 

8:00am CDT

Coffee and Light Refreshments TBA

9:00am CDT

#401: FDA Forum S105

10:30am CDT

Coffee Break TBA

10:45am CDT

#408: Flexing Your Project Management Muscles Outside of Traditional Roles S404d #412: EMA/ FDA Question Time S105