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CCT Venues

Oct 12, 2022 2:00 PM - Oct 13, 2022 10:30 PM

Level 32, 40 Bank Street, London, E14 5NR, United Kingdom

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

EU1 UK QPPV

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.

Speaker(s)

Lilly  Wells

Proactive safety surveillance and risk management planning for COVID-19 vaccines - Regulatory perspective: Lilly Wells

Signal Management Team Manager, Patient Safety Monitoring

MHRA, United Kingdom

Catherine  Tregunno

Proactive safety surveillance and risk management planning for COVID-19 vaccines - Regulatory perspective: Catherine Tregunno

Head of Benefit-Risk Unit for Vaccines, Infectious Disease and Diagnostics

MHRA, United Kingdom

Emil Andrei  Cochino, MD, MHS

Proactive safety surveillance and risk management planning for COVID-19 vaccines - Regulatory perspective: Emil Andrei Cochino, MD, MHS

Scientific Senior Specialist (Risk Management)

European Medicines Agency, Netherlands

Robert  Massouh, MPharm, RPh

Proactive safety surveillance and risk management planning for COVID-19 vaccines - Industry Perspective: Robert Massouh, MPharm, RPh

Director - Risk Management Product Lead

Pfizer Ltd, United Kingdom

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