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Pharmacovigilance Strategies Workshop

Engage in the sharing of good practices between industry representatives and seek advice from regulators in this unique workshop

Session 3: Lessons Learnt From The Regulator and Industry Experience With COVID-19 Vaccines

Session Chair(s)

Francoise  Sillan, MD

Francoise Sillan, MD

  • Ipsen, France
Shahin  Kauser

Shahin Kauser

  • Leading Senior Scientific Assessor
  • MHRA, United Kingdom

The COVID pandemic has made way for innovative options to be considered to allow proactive safety surveillance on a grand scale to ensure issues were identified and assessed in a timely manner. Furthermore, it brought to the front the importance of accurate, clear and concise communications tailored for healthcare professionals, patients and the public. All of this could only be achieved by effective risk management planning for COVID-19 vaccines.

This session aims to provoke thinking and provide participants with the tools and strategies to develop and conduct proactive safety surveillance utilising appropriate innovative tools such as artificial intelligence to identify, prioritise and assess safety signals in a timely manner. An insight will be given into achieving effective risk management and risk communication taking into account the sensitivities around COVID-19 vaccines. The interactive panel discussion will provide an invaluable opportunity to participants to actively discuss these topics in detail.


Lilly  Wells

Proactive surveillance of COVID-19 vaccines

Lilly Wells

  • Associate signal assessor
  • MHRA, United Kingdom
Emil Andrei  Cochino, MD, MHS

Risk management including risk communication

Emil Andrei Cochino, MD, MHS

  • Scientific Officer, Risk Management Specialist, Office of vaccines and therapies
  • European Medicines Agency, Netherlands
Catherine  Tregunno

Risk management including risk communication

Catherine Tregunno

  • Head of Vaccines, Infectious Disease and Diagnostics
  • MHRA, United Kingdom
Robert  Massouh, MPharm, RPh

Industry Perspective

Robert Massouh, MPharm, RPh

  • Risk Management Product Lead
  • Pfizer Ltd, United Kingdom

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