Manufacturers must now also consider the impact of Brexit on existing SA processes.
TORONTO (PRWEB) August 25, 2020
In Europe, “scientific advice” (SA) refers to an early dialogue between a manufacturer, health technology assessment (HTA) bodies and/or regulators on initial evidence generation for relative effectiveness and cost effectiveness assessments. The SA and parallel scientific advice (PSA) processes are valuable in helping companies to develop evidence that demonstrates the value of their product, to gain detailed feedback on their evidence generation plans, to integrate cost-effectiveness considerations into health technology assessments (HTA) and to better understand the concerns and perspectives of HTA and/or regulatory decision makers.
Manufacturers must now also consider the impact of Brexit on existing SA processes. For example, while the UK National Institute for Health and Care Excellence (NICE) is a leader due to the potential applicability of its advice to over 20 countries, it will no longer be able to provide parallel advice with the European Medicines Agency (EMA) through the European Network for Heath Technology Assessment (EUnetHTA) and will have to develop concurrent advice.
Join Celine Taveau, Principal, Global HTA, Health Economics, Reimbursement and Outcomes, ICON plc and Emmanuel Lacharme, Senior Consultant, Global HTA, Health Economics, Reimbursement and Outcomes, ICON plc in a live webinar on Thursday, September 10, 2020 at 11am EDT (4pm BST/UK).
For more information or to register for this event, visit Using Early Scientific Advice in Drug Development: Opportunities and Challenges.
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