Her areas of expertise include the cutting-edge early market access schemes that are being trialed around the world for taking drugs and medical devices to market faster. She is also interested in initiatives for harmonizing regulations at the global level as well as issues affecting clinical trials, manufacturing and post-market safety monitoring. She explores the challenges and opportunities that these issues introduce for both industry and the regulators and is on a constant look out for what might be coming next.
A scientist by training, Neena started her journalistic career at Informa in 1997. She has been the deputy editor of Scrip Regulatory Affairs since 2007. Prior to that, she worked as the science editor for Clinica Medtech Intelligence. Before becoming a journalist she worked as a biomedical scientist at St Thomas' Hospital in London for 10 years.
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Latest From Neena Brizmohun
Janssen and AstraZeneca are among a raft of companies that might this week find out whether the European Medicines Agency will recommend approval of their products for expanded therapeutic indications.
Oral explanation meetings are due to take place this week for drug sponsors who have a final chance to address questions and concerns the European Medicines Agency has about their marketing applications.
The EU marketing application for cefiderocol that lost fast track status last July is now up for an opinion by the European Medicines Agency.
Increased fines and penalties are on the cards for manufacturing facilities that fail to comply with proposed new requirements.
Filing for clinical trial activities in the electronic common technical document format via the Common Electronic Submission Gateway is expected to help sponsors send their information in a secure manner, with reduced transmission times and cost.
Roche hopes that its investigational drug satralizumab for neuromyelitis optica spectrum disorder will win EU approval in the second half of 2020.