The future of protocols featuring TransCelerate, CDISC and regulatory experts

Description

Clinical trial protocols are evolving. Changes in clinical trial complexity, patient and public input, templates, and digitalisation are reshaping their content and the approach that trial teams take during the protocol development process.
This session will include speakers from a range of industry and regulatory backgrounds. There will be presentations describing the stakeholders’ contributions to protocol standards and content evolution – including topics such as industry standardisation, ICH M11, ICH E6(R3), regulatory challenges and more.
Speakers will bring a diversity of personal and professional prospectives to help medical writers prepare for the protocol needs of the future.

Presentations will be followed by a moderated panel discussion including representatives from TOPRA, Patient Voice and Quality by design experts.