Spring Intro 2023

16/02/2023

Industry Expectations for Clinical Trials - The Overall Regulatory Role

● Advise team on regulatory expectations & requirements – Timelines for submission & approval, country requirements, compliance with regulatory requirements ● Facilitate efficient study start-up - target LPI and work backwards! – Timely regulatory approvals are vital, remove any regulatory hurdles where possible ● Consider the big picture of entire product development, Marketing Authorisation Application strategy & indications in label

21

Final takeaways…..

● Essential to have good regulatory knowledge and up to date intelligence ● Be aware of the evolving Clinical trial landscape - Consider VHP while you can! ● Your role is to help manage the complexity of clinical trial submissions and gain timely approvals ● Important to work with the regulators to ensure rapid drug development and deliver medicines to patients FASTER

22