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Collaboration in an Expanding Regulatory Landscape for Pharmacovigilance
Session Chair(s)
Sophie Radicke, MSc
Head of GPvP and Senior Pharmacovigilance Inspector
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Understanding the safety of medicines and the risks imposed by their use is of interest to regulators around the world. This poses challenges for industry who are faced with meeting the regulatory requirements and expectations of multiple Healthcare Agencies from across the globe. This challenge is becoming greater still as more countries start to enter the world of PV.
This session will focus on how regulators are working together to share information and intelligence and how experienced regulatory agencies are working with nations currently establishing pharmacovigilance regulations to implement these and develop the skills and knowledge required to ensure compliance and establish accepted best practice.
Learning Objective : Describe the challenges faced by industry from a global perspective and gain insight into how regulatory agencies are working together to combat some of these issues; Discuss information and educate countries where PV is an emerging concept; Discuss areas where processes can be improved to make global PV more aligned and less challenging for industry and regulators alike.
Speaker(s)
MHRA Update
Phil Tregunno
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Deputy Director - Patient Safety Monitoring
FDA Update
Carolyn Volpe, PharmD, MS
FDA, United States
Team Leader, OSI, OC, CDER
Update from Ghana
Adela Ashie
Food and Drugs Authority, Ghana
Principal Regulatory Officer
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