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Session 6: Risk Management – Established vs ongoing studies
Session Chair(s)
Vijay Bhargav
Vice President, Lifecycle Safety
IQVIA, India
Assessing benefit versus risk is key to decision making throughout the life cycle of any drug/product. Over the past decades, the method of conducting benefit-risk (BR) assessments have evolved from a non-structured and often mainly qualitative process to one that has become increasingly systematic and more transparent. While for approved medicines, there are established framework and milestones for benefit-risk assessment, it would be interesting to review how is BR monitored and continually assessed in a pandemic situation.
Speaker(s)
Pharmacovigilance activities with respect to risk Management and its application
Pradeepa Ramakrishna
Astrazeneca India Private Limited, India
Director, Patient Safety
Selection & Evaluation of Effectiveness of Risk Minimisation Tools – Case Study
Dnyaneshwar Sanap, DrMed
Glenmark Arzneimittel GmbH, Germany
EU QPPV
Post-marketing surveillance and risk management for Medical devices-Pharmacovigilance vs Device vigilance
Naila Haris
IQVIA , India
BRM lead- Safety and Aggregate Reporting Analytics department
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