Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Don't Let Sponsors Downplay Genuine Safety Concerns At Public Hearings, HAI Tells EMA

This article was originally published in SRA

Executive Summary

After the European Medicines Agency's pharmacovigilance committee (PRAC) finalized rules on how it would conduct public hearings to support the safety review of certain marketed medicines earlier this month1-3, medicines advocacy group Health Action International said that it welcomed the move, but warned that drug sponsors should not be allowed to downplay genuine safety concerns at such hearings.

Advertisement

Related Content

Waiting For The Perfect Case: Why EMA Has Yet To Hold A Public Drug Safety Hearing
EMA Public Hearings On Marketed Medicines To Start Next Year
EU Drug Safety Actions Speeded Up By New Legislation, Says Commission
Advertisement
UsernamePublicRestriction

Register

PS118623

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel