PIPA Global Forum – Pharmacovigilance Day, Monday 22nd March 2021

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March 22 @ 11:00 AM - March 22 @ 5:15 PM


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PIPA Global Forum – Pharmacovigilance Day, Monday 22nd March 2021


11.00 – 12.00 The Impact of Brexit – John Barber, Plain Pharma Consulting Ltd

‘Brexit is Brexit’ was Theresa May’s promise. Four years later, Brexit has now been delivered. This session will review the immediate impacts of Brexit on pharmacovigilance and device vigilance, but will also consider some of the potential future impacts. Are there any broad, sunlit uplands for pharmacovigilance?

12.00 – 12.15 Comfort Break
12.15 – 13.15 The globalisation and harmonisation of pharmacovigilance regulations – Brian Edwards, NDA GroupHow will Global Britain adapt to the growing and emerging global pharmacovigilance (PV) system? As PV progresses in many countries this accentuates previous regulatory differences in the main ICH regions and the PV professional will need to adapt and remember the guiding principles that have been laid out by ICH and CIOMS. New technologies will drive change and require system redesign so that they can be efficiently implemented. Global initiatives about aggregate reporting and benefit-risk are making progress to help create a more efficient quality system throughout the lifecycle of a healthcare product.
13.15 – 14.00 Lunch
14.00 – 15.00 A comparison of RMP and REMS risk management systems: What considerations and lessons can be learned? – Nancy Dubois, Alexion

This program will provide an overview of the similarities and differences between RMP and REMS risk management systems. In addition, this program will provide best practices and suggestions on how one might leverage the different strategies to reduce barriers to treatment while also ensuring patient safety and regulatory compliance in the ever-changing healthcare landscape.

15.00 – 15.15 Comfort Break
15.15 – 17.15 QPPV Hot Topics –  Jackie Roberts, Accord Healthcare; Tom Nichols, Drive Phase PV; Janine Gavin-Poulter, Perrigo Company Ltd; Anne Lloyd, Ethypharm & Martindale Pharma

A panel discussion and open forum on the hot topics facing QPPVs globally, including:

– Changes in organisational structure due to Brexit

– Outsourcing QPPV roles, in large organisations

– Local QPPV responsibilities and their management

– Ensuring QPPV oversight of non-PV activities