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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

  • VP GPS TA ENDO-ONCO & EU QPPV
  • Ipsen, France
Guy  Demol

Guy Demol

  • EU QPPV
  • 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.

Speaker(s)

Emil Andrei  Cochino, MD, MHS

Regulators Experience with Vaccines Safety Assessment

Emil Andrei Cochino, MD, MHS

  • Scientific Officer, Risk Management Specialist, Office of vaccines and therapies
  • European Medicines Agency, Netherlands
Patrick M. Caubel, PhD, MBA

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

Patrick M. Caubel, PhD, MBA

  • Chief Safety Officer
  • Pfizer, United States
Frederic  Bouder, PhD

Communication of Benefit Risks to the Public: Impact of Media

Frederic Bouder, PhD

  • Professor in Risk Management
  • University of Stavanger, Norway