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
Updated guidance on France’s experimental fast-track procedure for approving clinical trials shows that the pathway has entered a new phase.
The Therapeutics Goods Administration has begun a second public consultation on how it intends to improve its rules for 3D-printed and other personalized medical devices after stakeholders called for more clarification to proposals made in 2017.
Australia is proposing to introduce new medical device software rules that would result in a number of changes for industry. Health Canada, meanwhile, has developed a draft guidance for software as a medical device to better define the regulatory compliance requirements for emerging technologies.
The US drug regulator may now rely on a total of 22 EU member states whose inspection results can replace its own inspections.
A new checklist for companies from the European Medicines Agency is designed to facilitate the agency's validation of initial marketing authorization applications and make this process more predictable and easier to navigate.
The European Medicines Agency says that its IRIS portal will reduce the time needed for parallel distributors to prepare and submit notifications.