Shirley Hopper

Company: Medicines & Healthcare products Regulatory Agency

Job title: Deputy Director of National Licensing Strategy

Seminars:

Panel Discussion – A European Industry & Regulatory Perspective on the Development & Approval of mRNA Medicines 5:30 pm

Uncovering how regulatory provisions can support mRNA medicines’ approval Reducing the regulatory approval timeline through platform technology approaches Moving towards a harmonized approach for mRNA medicines for the benefit of patientsRead more

day: Day 1 PM

Presenting MHRA’s Perspectives & Draft Guidance on the Licensing of Individualised mRNA Cancer Immunotherapies 5:00 pm

Individualised mRNA cancer immunotherapies (cancer vaccines) pose new regulatory challenges since the mRNA sequence is matched to the patient’s unique tumour neoantigen profile and HLA type The MHRA aims to publish draft scientific and regulatory guidance for developers of individualised mRNA cancer vaccines by the end of 2024. This will include sections on regulations, manufacturing,…Read more

day: Day 1 PM