Spring Intro 2023

03/03/2023

Registration and approval

Establish Quality, Safety & Efficacy  Approval!! ● Global Regulatory Strategy – Optimise development leading to approvals (time, resources, procedures) ● Simultaneous submissions in key regions? i.e. US, EU, JPN; UK, CAN, SWZ, CHN, BRZ, SA, AUS/NZ ● Meetings with regulatory authorities (from Phase II or earlier – “PRIME”), seek national and CHMP Scientific Advice, HTA input, minimise questions & surprises!

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Outcomes research (pharmaco-economics)

Measures economic and quality of life implications of medicines – “Effectiveness of product” Data used in ‘value for money’ driven healthcare markets to: ● Secure reimbursement & justify pricing – Health Technology Assessment (HTA) e.g. NICE, IQWIG/GBA ● Support marketing ● Get on formularies Endpoints included in Phase III (or II) studies ● Consider parallel HTA/regulatory agency advice/consultation

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