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Session 3: Lessons Learnt From The Regulator and Industry Experience With COVID-19 Vaccines
Session Chair(s)
Francoise Sillan, MD
EU1 UK QPPV
Ipsen, France
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)
Proactive safety surveillance and risk management planning for COVID-19 vaccines - Regulatory perspective
Lilly Wells
MHRA, United Kingdom
Signal Management Team Manager, Patient Safety Monitoring
Proactive safety surveillance and risk management planning for COVID-19 vaccines - Regulatory perspective
Catherine Tregunno
MHRA, United Kingdom
Head of Benefit-Risk Unit for Vaccines, Infectious Disease and Diagnostics
Proactive safety surveillance and risk management planning for COVID-19 vaccines - Regulatory perspective
Emil Andrei Cochino, MD, MHS
European Medicines Agency, Netherlands
Scientific Senior Specialist (Risk Management)
Proactive safety surveillance and risk management planning for COVID-19 vaccines - Industry Perspective
Robert Massouh, MPharm, RPh
GSK, United Kingdom
Head of (Safety) Risk Management and Benefit/Risk Evaluation
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