Welcome to the 2025 ISPE Annual Conference.

**Please Note: Listed times are for the Eastern Time Zone (ET)**

INSTRUCTIONS

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Plenary Session 1

8:00 AM – 10:00 AM ET

Welcome to ISPE 2025 and Keynote Session: Pragmatic Pharmacoepidemiology: Innovative Clinical Evidence Supporting Regulatory Decision-making

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Oral Presentations Session 1

10:30 AM – 12:00 PM ET

1A – Comparative safety and effectiveness in cardio/renal/metabolic diseases

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10:30 AM – 12:00 PM ET

1B – COVID-19 and recovery

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10:30 AM – 12:00 PM ET

1C – Maternity Medley

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10:30 AM – 12:00 PM ET

1D – Non-Covid Vaccines: Protecting Health and Building Trusts

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10:30 AM – 12:00 PM ET

1E – Safer drugs for mental illness and addiction

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10:30 AM – 12:00 PM ET

1F – The algorithm awakens: pregancy and data

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10:30 AM – 12:00 PM ET

1G – To err is not only human

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Symposia & Workshops: Session 1

1:30 PM – 3:00 PM ET

SW-1A – Building transparency and reproducibility into the practice of pharmacoepidemiology and outcomes research

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1:30 PM – 3:00 PM ET

SW-1B – Bridging Real-world and RCT Endpoints: Mitigating Measurement Error Bias in Time-to-event Endpoints in Studies using Oncology Real-world Data

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1:30 PM – 3:00 PM ET

SW-1C – Consolidated Multi-product/Disease-based Pregnancy Exposure Registries: How to Encourage Collaboration in a Fragmented Environment?

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1:30 PM – 3:00 PM ET

SW-1D – What are possible approaches when the active comparator new users design (ACNU) is not easily applicable?

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1:30 PM – 3:00 PM ET

SW-1E – Advances in Pharmacoepidemiology in Africa: The African Regional Interest Group Experience

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1:30 PM – 3:00 PM ET

SW-1F – Integrating Real-World Data with Randomized Controlled Trials: Advancing Evidence Generation

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1:30 PM – 3:00 PM ET

SW-1G – What can pharmacoepidemiologists do to enhance vaccine confidence?

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Oral Presentations: Session 2

3:30 PM – 5:00 PM ET

2A – A Dose of Disparity: Measuring Inequality in Healthcare

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3:30 PM – 5:00 PM ET

2B – A fine assortment of drug safety talks

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3:30 PM – 5:00 PM ET

2C – Innovative Methods and Designs in Vaccine Research: Advancing Precision and Impact

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3:30 PM – 5:00 PM ET

2D – Lightning Session 1

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3:30 PM – 5:00 PM ET

2E – Methods mixer

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3:30 PM – 5:00 PM ET

2F – Mining expeditions

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3:30 PM – 5:00 PM ET

2G – Navigating the Neurochemical Journey in Pregnancy

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Symposia & Workshops: Session 2

5:15 PM – 6:45 PM ET

SW-2A – Real-World Evidence in Regulatory Decision-Making for Medical Products

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5:15 PM – 6:45 PM ET

SW-2B – The Clone-Censor-Weight Approach: From Basic Principles to Its Transformation in Diverse Exposure and Outcome Scenarios

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5:15 PM – 6:45 PM ET

SW-2C – Dynamic Modeling of Medication Adherence: A Hands-on Exploration of Trajectory Analysis Techniques

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5:15 PM – 6:45 PM ET

SW-2D – The Future of Pharmacovigilance: Accelerating Signal Identification With Electronic Healthcare Data

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5:15 PM – 6:45 PM ET

SW-2E – Resolved That the Hierarchy of Evidence Should Be Replaced: A Debate

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5:15 PM – 6:45 PM ET

SW-2F – Overcoming Challenges in CDM Harmonization from Within-Country Coordination to International Collaboration

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5:15 PM – 6:45 PM ET

SW-2G – Addressing the threat of confounding in pharmacoepidemiology with innovative methods: Lessons from the FDA Sentinel Innovation Center

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Oral Presentations: Session 3

8:15 AM – 9:45 AM ET

3A – Drug effectiveness from head-to-toe

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8:15 AM – 9:45 AM ET

3B – Keep pumping: cardiovascular and respiratory drug safety

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8:15 AM – 9:45 AM ET

3C – Lightning Session 2

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8:15 AM – 9:45 AM ET

3D – Machines make it easier

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8:15 AM – 9:45 AM ET

3E – Metabolic risk and cardiovascular disease

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8:15 AM – 9:45 AM ET

3F – Older Adults Are All Heart

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8:15 AM – 9:45 AM ET

3G – Trial & Triumph: Targeting Success in Pregnancy Studies

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Plenary Session 2

10:15 AM – 11:30 AM ET

Plenary: Burdens of Proof in the Pharmaceutical Century

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Symposia & Workshops: Session 3

1:00 PM – 2:30 PM ET

SW-3A – Navigating Around Quicksand: Mapping the Complexities of Externally Controlled Trial (ECT) Designs

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1:00 PM – 2:30 PM ET

SW-3B – Developing Computable Phenotypes for Medical Product Safety Surveillance: Innovative Methods and Data Sources

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1:00 PM – 2:30 PM ET

SW-3C – How should we interpret self-controlled study designs in the era of causal inference?

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1:00 PM – 2:30 PM ET

SW-3D – Real World Evidence generation in Low and Middle Income Countries for vaccines

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1:00 PM – 2:30 PM ET

SW-3E – Advances in Medical Device RWE Use for Label Expansions and National Coverage Decisions

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1:00 PM – 2:30 PM ET

SW-3F – Introduction to R Shiny for Pharmacoepidemiologists: Interactive Visualization in Real-World Evidence Studies

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1:00 PM – 2:30 PM ET

SW-3G – Precision Medicine and Pharmacoepidemiology Synergistic Approaches to Real-World Evidence

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Plenary Session 3

2:50 PM – 4:00 PM ET

AGM & Awards Ceremony

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Oral Presentations: Session 4

4:15 PM – 5:45 PM ET

4A – A Cohort is a Cohort: Utility for Pharmacovigilance

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4:15 PM – 5:45 PM ET

4B – Can cancer treatment be safer?

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4:15 PM – 5:45 PM ET

4C – Chronic drugs for chronic illness

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4:15 PM – 5:45 PM ET

4D – High-value Outcomes

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4:15 PM – 5:45 PM ET

4E – Monumental Evidence: Foundations for Benefit/Risk Decision-Making

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4:15 PM – 5:45 PM ET

4F – Pediatrics: Growth and Development, the Brain and the Body

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4:15 PM – 5:45 PM ET

4G – PS…are you still there?

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Oral Presentations: Session 5

8:30 AM – 10:00 AM ET

5A – Addicted to pharmacoepidemiology

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8:30 AM – 10:00 AM ET

5B – Clone wars

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8:30 AM – 10:00 AM ET

5C – Covid-19 Vaccine Safety: Science, Facts, and Public Health

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8:30 AM – 10:00 AM ET

5D – Disproportionality Proportionate: Pharmacovigilance Methods

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8:30 AM – 10:00 AM ET

5E – The safety dance: drugs for obesity and metabolic disorders

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8:30 AM – 10:00 AM ET

5F – Use and Safety of Biologics

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8:30 AM – 10:00 AM ET

5G – What a Mess: the Environment, Health, and Medications

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Symposia & Workshops: Session 4

10:30 AM – 12:00 PM ET

SW-4A – Harnessing Real-world Evidence to Address Drug Shortages

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10:30 AM – 12:00 PM ET

SW-4B – Real-world evidence fit for regulatory applications — what does good look like?

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10:30 AM – 12:00 PM ET

SW-4C – Environmental Challenges to Supply Chains and Drug Shortages

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10:30 AM – 12:00 PM ET

SW-4D – Why Treatment Strategies are a Sine Qua Non of the Causal Estimand

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10:30 AM – 12:00 PM ET

SW-4E – Use of Artificial Intelligence/Machine Learning Methods for Identification of Patients with Rare Diseases in Real-World Data

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10:30 AM – 12:00 PM ET

SW-4F – Approaches to Time-Zero and Time-Related Bias in External Control Arm Study Design: Methodological Considerations and Applications

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10:30 AM – 12:00 PM ET

SW-4G – Seeking the roadmap: Incorporating menstruation and menopause into pharmacoepidemiology research

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Oral Presentations: Session 6

1:30 PM – 3:00 PM ET

6A – Aging, Meds, and Modern Challenges: Navigating the Multiverse of Care for Older Adult

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1:30 PM – 3:00 PM ET

6B – Cracking the Code in Pregnancy Studies

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1:30 PM – 3:00 PM ET

6C – Drug Effectiveness in veterans and friends

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1:30 PM – 3:00 PM ET

6D – Lightning Session 3

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1:30 PM – 3:00 PM ET

6E – One size fits none: unravelling treatment heterogeneity

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1:30 PM – 3:00 PM ET

6F – Perfect timing

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1:30 PM – 3:00 PM ET

6G – The target stands trial

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Plenary Session 4

3:15 PM – 4:15 PM ET

Hot Topic Debate: Large Language Models and AI in Pharmacoepidemiology: Job tool or job takeover?

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3:45 PM – 5:00 PM ET

The Final Word

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