Shirley Hopper

Company: Medicines & Healthcare products Regulatory Agency

Job title: Deputy Director National Licensing Strategy

Seminars:

Panel Discussion – A European Industry & Regulatory Perspective Into the Development & Route to Approval for Personalised mRNA Cancer Therapies 5:15 pm

Uncovering how successful mRNA cancer vaccine trials are selecting patients and achieving clinical endpoints How to reduce the personalised cancer vaccine timeline by central manufacturing and optimised logistics Navigating the regulatory frameworks for personalised medicine to ensure success post-approval  Navigating the regulatory frameworks for personalised medicine to ensure success post-approvalRead more

day: Day 1 PM

Presenting MHRA’s Perspectives & Draft Guidance on the Licensing of Individualised mRNA Cancer Immunotherapies 4:15 pm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