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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

New Combination Product Registration Rules Coming To Malaysia

New guidance explains how Malaysia’s impending rules for registering combination products will work when they come into force in July 2018, and how much sponsors will have to pay to have their applications assessed.

Combination Products Review Pathway

New Combination Product Registration Rules Coming To Malaysia

New guidance explains how Malaysia’s impending rules for registering combination products will work when they come into force in July 2018, and how much sponsors will have to pay to have their applications assessed.

Combination Products Review Pathway

Japan’s New 'Fast-Break Scheme' To Reduce Clinical Trial Burden For Medtech

Japan’s “fast-break scheme” is coming soon and will be the country’s fourth procedure for accelerating the approval of important medical devices.

Approvals Clinical Trials

Australia Insists Orphan Designations Will Last Only Six Months, Overrides Industry Objections

Sponsors making drugs for rare diseases in Australia who fail to file for approval within six months of being granted orphan designation will see their designation disappear, the Therapeutic Goods Administration has decided. The new procedure will be problematic for orphan drug sponsors and might even make it more difficult for them to use the new expedited pathways the agency is planning to introduce for innovative drugs.

Rare Diseases Australia

EMA Addresses Industry’s Problems With Periodic Safety Update Reports

The EMA says that newly released guidance should make the preparation of periodic safety update reports less of a challenge for industry, and recommends that all marketing authorization holders read it.

Drug Safety Regulation

'Readily Usable' Harmonized AE Reporting Terms Promise Faster Signal Detection

The International Medical Device Regulators Forum says its new terms and codes for reporting adverse events are readily usable and will speed up safety-signal detection.

Safety Medical Device
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