SESSION 13. PARALLEL SESSION - AGGREGATE REPORTS AROUND THE WORLD

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Introduction by the Chairperson

• November, Thursday 20 | 13:45 - 13:50

HRVOJE MACEK

PRIMEVIGILANCE

Optimizing DSUR: Pragmatic strategies for efficient safety updates

• November, Thursday 20 | 13:50 - 14:10

ELENA PROKOFYEVA

FAMHP - Coordinator of Drug Safety Unit

Japanese Development Safety Update Report (J-DSUR) and Japanese PeriodicBenefit-Risk Evaluation Report (J-PBRER); specific requirements for aggregate reports in Japan

• November, Thursday 20 | 14:10 - 14:30

VJERA BILUSIC VUNDAC

PRIMEVIGILANCE LTD - Senior Director, Medical Writing

Challenges and possible solutions in meeting local regulatory requirements for safety aggregate reports

• November, Thursday 20 | 14:30 - 14:50

ANTONELLA FRETTA

PFIZER - Senior Director

Round Table

• November, Thursday 20 | 14:50 - 15:20

HRVOJE MACEK

PRIMEVIGILANCE

VJERA BILUSIC VUNDAC

PRIMEVIGILANCE LTD - Senior Director, Medical Writing

ANTONELLA FRETTA

PFIZER - Senior Director

ELENA PROKOFYEVA

FAMHP - Coordinator of Drug Safety Unit