Pink Sheet is part 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

European Medicines Data Standards Offer Business Opportunities For Life Science Firms

Executive Summary

The newly published EU IDMP guide on implementing ISO data standards for the identification of medicinal products will keep regulatory affairs professionals busy with compliance work while also creating new data-driven opportunities for life sciences companies. Remco Munnik shares the inside track from his work with the EU focus group that created the guide.

You may also be interested in...



QUOTED. 6 May 2020. Paul Diaz.

Myriad has sold several business units as it narrows its focus to oncology, women's health and mental health diagnostics. CEO Paul Diaz says the moves will allow the company to be a market leader.

After ODAC: The State Of Accelerated Approval At The US FDA

US FDA’s Accelerated Approval process has always been a deceptively simple idea. After a three-day public review of ‘dangling’ applications, the underlying complexity remains.

Merck’s Keytruda: The ‘Wall Of Data’ Still Holds After ODAC Look Back

Merck has pulled one Accelerated Approval indication for Keytruda already this year, and a second may have to be withdrawn as well. That will leave the product with 27 indications in the US – unless, of course, more are approved before the AA indications are formally pulled.

Topics

UsernamePublicRestriction

Register

PS144134

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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