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Neena Brizmohun

Executive Editor

Neena has been covering regulatory, business and market access developments that impact pharmaceutical and medical device companies since 1997. She explores the challenges and opportunities that developments worldwide introduce for industry and regulators. Her areas of expertise include regulatory schemes for getting products to market faster. Neena's other specialist areas include new medicines coming to market in the EU, pricing and reimbursement, clinical trials, real-world evidence, post-marketing safety monitoring, transparency policies relating to the publication of trial data, and global harmonization initiatives for pharma and medtech.

Latest From Neena Brizmohun

EU Regulators Clarify How ‘Super-Grouping’ Under New Variations Rules Will Work

Feedback is being sought on revised guidelines that tell companies how they should make post-authorization changes to their drug approvals once new rules take effect in January 2025.

Post Market Regulation & Studies Europe

ICH Cuts Burden Of Assessing Drug-Drug Interactions; Argentina Gains Membership

New guidance from the International Council for Harmonisation is designed to tackle problems companies face by having to meet different requirements around the world when evaluating the potential of DDIs for their investigational products.

International Drug Safety

EU Launches New Mechanisms To Boost Quality Of Clinical Trial And Marketing Applications

As of today, drug developers can apply to take part in two pilot programs that will involve regulators across the EU strengthening their coordination when it comes to providing companies with advice on their applications for clinical trials and marketing authorization.

Europe Clinical Trials

A Success But Room For Improvement: Canada’s Conditional Approval Pathway

Ninety-two approvals, seven revocations and myriad standard-of-care treatments are all discussed in a first-of-its kind study examining the data and nuances of oncology submissions processed under Health Canada’s 26-year-old notice of compliance with conditions (NOC/c) pathway.

Canada Post Market Regulation & Studies

New EU Approvals

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add three new products, including Qalsody, Biogen's treatment for amyotrophic lateral sclerosis associated with a mutation in the superoxide dismutase 1 gene.

Europe Approvals

Regulators Tackle Challenges With Pharmacoepidemiological Studies That Use RWD

An internationally harmonized framework for generating adequate evidence using fit-for-purpose real-world data to address regulatory questions on the safety of medicines is out for public consultation.

Post Market Regulation & Studies Europe
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