Starts in 16h 8m
Research Methods

Real-World Evidence: Getting Regulators to Yes

Sunday, 1 November 2026
9:30 am - 11:00 am
Seminar Room 2.1 (L2-SEM-1)

About

Two perspectives on regulatory-grade real-world evidence: the study team’s and the reviewer’s.

Program

9:30 am

From Registry to Label Extension: A Worked Example

Hiroshi Sato, Kansai Clinical Outcomes Network

45 min
10:15 am

Real-World Evidence From the Reviewer’s Chair

Rachel Goldberg, Independent

45 min

Q&A for Real-World Evidence: Getting Regulators to Yes

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Polls

Speakers
HS

Hiroshi Sato

Lead, Real-World Evidence, Kansai Clinical Outcomes Network

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RG

Rachel Goldberg

Regulatory Science Advisor, Independent

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Details

Track

Research Methods

Duration

90 minutes

Room

Seminar Room 2.1

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