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Sep 07, 2021 7:00 PM - Sep 10, 2021 12:30 AM

(Central Europe Standard Time)

Pharmacovigilance Strategies Workshop

Navigating the changing PV landscape in your daily work. Anniversary edition: 5 years

Session 4: Risk Management And Communication For Vaccines. Biotherapeutics Impact Of Covid-19 Pandemic

Session Chair(s)

Francoise  Sillan, MD

Francoise Sillan, MD


Ipsen, France

Guy  Demol

Guy Demol


MSD, Belgium

Effective communication about safety of vaccines and vaccination is critical: perceptions of harm may persist despite evidence that a serious adverse event is not related to the vaccination and communicating about vaccine safety to multiple audiences (e.g. healthcare providers, patients and parents) is complex.

The ongoing threat to global health from COVID-19 poses critical challenges with an abundance of information and misinformation on the disease and on vaccination. The stakeholder’s perceptions regarding vaccine safety has an impact on coverage rates. This session will explore these different challenges from regulator, industry and academic perspectives.


Emil Andrei  Cochino, MD, MHS

Regulators Experience with Vaccines Safety Assessment

Emil Andrei Cochino, MD, MHS

European Medicines Agency, Netherlands

Scientific Senior Specialist (Risk Management)

Patrick M. Caubel, MD, PhD, MBA

Development of Vaccines and Biotherapeutics: Addressing the Emergency – Experience from Industry

Patrick M. Caubel, MD, PhD, MBA

Pfizer Inc, United States

Chief Safety Officer

Frederic  Bouder, PhD

Communication of Benefit Risks to the Public: Impact of Media

Frederic Bouder, PhD

University of Stavanger, Norway

Professor in Risk Management

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