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
More stringent recall rules in China will see the maximum penalty for failure to carry out a mandatory recall rise from three times the value of a medical device, to up to ten times its value.
New proposals by Australia’s Therapeutic Goods Administration include developing a list of unauthorized medical devices that could be made available to patients faster and more easily. A decision to include a product on the list would not be appealable, the TGA says.
New proposals by Australia’s Therapeutic Goods Administration include developing a list of unauthorized drugs that could be made available to patients faster and more easily. A decision to include a product on the list would not be appealable, the TGA says.
All marketing approval applications submitted via Europe’s decentralized procedure are being processed under a new pilot that should help regulators validate applications faster. The pilot might also give companies a better understanding of the validation process and how omissions or mistakes in their documentation might invalidate or delay their applications.
Device industry groups are urging manufacturers and contract research organizations to get involved with an initiative to build medical device registries in Asia, the Middle East and North Africa, as regulators and reimbursement bodies in these regions increasingly focus on real-world data. They say stakeholders would be able to collaboratively assess this kind of data before any decisions were taken that could affect patient access to therapies.
A large number of defects have been fixed in the electronic application forms that drug makers must use when applying for marketing authorizations, renewals and variations.