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Neena Brizmohun

Neena Brizmohun writes and commissions news, features and analysis to meet the regulatory, business and market access information needs of the companies and regulatory agencies that operate in the pharmaceutical and medical device space worldwide.

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

EFPIA Welcomes EMA’s Electronic Format Plan For Package Leaflets But Not ‘Key Info’ Idea

The EMA has published an action plan on improving the product information companies provide in package leaflets and the SmPC.

Europe Regulation

Accelerated Development On The Cards In EU and US For Bluebird, Celgene’s CAR-T Therapy

Bluebird Bio and Celgene have secured a place on both the EMA’s PRIME scheme and the US FDA’s breakthrough therapy designation program for their multiple myeloma CAR-T therapy, bb2121. Meanwhile, Bluebird talks about how “incredibly helpful” PRIME has been with the development of LentiGlobin for beta-thalassemia.

Review Pathway Europe

EMA and HTA Bodies Launch Three-Year Plan To Better Understand Each Other’s Needs

Understanding how the EMA defines therapeutic indications and how this affects the definition of the treatment-eligible population by HTA bodies is one of the many goals of a new joint workplan by the agency and the EUnetHTA.

Europe Approvals

Australia Consults On Stricter Rules For Personalized And 3D-Printed Devices

The strict regulatory oversight that applies to conventionally produced implants would also start applying to similarly high-risk 3D printed implants under new proposals from Australia's Therapeutic Goods Administration.

Australia Policy & Regulation

India Settles On Classifications For Nearly 600 Devices, IVDs

The final list of medical devices and IVDs classifies products according to India’s imminent new rules for medtech products. It contains about 100 fewer entries than the original draft issued in June.

Asia Pacific India

Novartis Seeks EU Accelerated Review For CAR-T Therapy

Novartis, having now submitted its CAR-T therapy CTL019 to the European Medicines Agency for approval, should learn shortly whether the product will be assessed under the agency’s accelerated procedure.

Europe Drug Review
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