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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
The licence evaluation fee Health Canada charges for drugs containing new active substances could jump by 76% under proposals by the government department, which says its current fees for pharma and medtech are outdated and need to change.
The licence evaluation fee Health Canada charges for Class IV medical devices could jump from CAN$12,347-$22,560 to $30,063 under proposals by the government agency, which says the current fees it charges for medtech and pharma are outdated.
From next year drug manufacturers operating in Australia will have to start placing a black triangle symbol on the product information and consumer medicines information documents for certain newly approved prescription products and new indications.
Drug labels must be updated to factor in new safety advice on excipients, the European Medicines Agency says.
Cinfa Biotech is hoping that the advice it received from the EU regulators during the development of its pegfilgrastim biosimilar will help it succeed where others have failed.
The European Commission’s soon-to-be-published report on the EU Paediatric Regulation could lead to legislative changes that address some of the many problems pharma companies have with the 10-year old rules.