Latest from Vibha Sharma
As the consultation period draws to a close for the UK’s new inclusion and diversity guidance, researchers and sponsors are being invited to participate in a pilot next year to submit a diversity plan as part of their clinical trial application.
As the consultation period draws to a close for the UK’s new inclusion and diversity guidance, researchers and sponsors are being invited to participate in a pilot next year to submit a diversity plan as part of their clinical trial application.
The International Coalition of Medicines Regulatory Authorities wants to see the rapid establishment and efficient conduct of platform clinical trials during public health emergencies.
The International Council for Harmonisation is seeking input from IT vendors on what it will take to establish a state-of-the-art technology platform that drug sponsors can use to submit quality-related post authorization submissions for collaborative assessment by multiple regulatory authorities.
As drug companies continue to explore the use of social media data to support their submissions, a panel of EU regulators have drawn up a seven-point action plan to help evaluate the usefulness and impact of such data in regulatory decision-making.
The International Council for Harmonisation has issued for comment draft guidance, which when finalized, is expected to provide the industry with flexibility to embrace non-traditional, innovative approaches in clinical trial design.