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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

Australian Regulator: Don't Let New Ingredient Name Deadline Sneak Up On You

The Therapeutic Goods Administration is urging companies to update their medicine labels and documentation with new ingredient names.

Regulation Australia

New Filings At The EMA

New medicines under evaluation at the European Medicines Agency.
Drug Review European Performance Tracker

New EU Approvals

The Pink Sheet’s list of EU centralized approvals of new active substances now includes two new products, one of which is bluebird bio's genetically modified product for treating beta-thalassemia, Zynteglo. The list, which contains information dating back to January 2018, includes brand name, generic name, company, therapeutic indication, date of marketing authorization and product type (eg, medicine, vaccine, biologic).

Approvals Europe

Messy Rules For Non‐Biological Complex Drugs Under Fire

Calls are mounting for the EU to make the centralized procedure mandatory for follow-on versions of non‐biological complex drugs and for better regulatory alignment with the US and other countries.
Drug Review Europe

More Countries Join US-EU Inspections Deal

There are now just two European countries left to join the agreement between the EU and the US on recognizing the findings of inspectorates in each other’s jurisdictions.

Manufacturing Compliance

Here At Last: EU Guidance On Quality Rules For Drug-Device Combinations

New EU guidance includes more information for drug-device combination product makers who are worried about how to comply with requirements being introduced for pharmaceuticals under the new EU medical device rules.
Combination Products Quality
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