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Vibha Sharma

Vibha Sharma is a senior reporter covering pharmaceutical and medtech regulatory developments across the globe. She joined Scrip Regulatory Affairs in September 2010 and has since then been at the center of deciding and writing news on important regulatory issues affecting the pharma and medtech sectors and explaining their implications for the industry.

Her fields of interest include the EU Pharmacovigilance legislation and the EU Paediatrics Regulation on which she has written several exclusive articles from various industry conferences. She has also commissioned some pieces of expert analysis on major developments in the pharma and medtech regulatory arenas.

Before joining Informa, she was principal correspondent with India's national newspaper Hindustan Times, where she reported on health and medical issues, besides several other topics. She has also worked with two other Indian national dailies, The Indian Express and The Asian Age.

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Latest From Vibha Sharma

PIC/S Adopts New Guide On Cross-Contamination, Transposes EU GMP Requirements

The group representing international pharmaceutical inspectorates, PIC/S, has issued new guidance on controlling cross-contamination in shared facilities. It has also transposed several EU guidelines on good manufacturing practice that non-EEA participating authorities can adopt on a voluntary basis. 
International Europe

UK Regulator Promises Reasonable and Pragmatic Approach For EudraVigilance Inspections

Aware that marketing authorization holders are still finding their way around the EU’s revamped pharmacovigilance database – a UK inspector explains what procedures and processes companies should have in place to show compliance with new requirements to monitor and report safety signals.
Europe United Kingdom

Increase In Antibacterial R&D Prompts EMA Proposal For Improved Guidance

Following a resurgence of activity in the field of antibacterial products, the European Medicines Agency has proposed merging and updating its two existing guidelines on this topic into a single, clearer, core document.

Europe Clinical Trials

EMA's Revised Pediatric Class Waiver List Comes Into Effect July 28

Marketing authorization applications for medicines that are no longer subject to a class waiver as per the revised list will need a pediatric investigation plan.
Europe Clinical Trials

EU Patients Decry Medical ‘Ignorance’ About Side-Effects Of Quinolones & Fluoroquinolones

At the European Medicines Agency's second ever public hearing on the safety of marketed medicines, patients gave an emotional account of how they battled with 'ignorance' within the EU medical community about the severely debilitating and potentially permanent side-effects of some broad-spectrum antibiotics.
Europe Regulation

EU Group Probes Incorrect Use Of National Procedures For Marketing Applications

The EU's regulatory coordination group, the CMDh, is concerned that some companies are submitting parallel marketing authorization applications under national procedures, creating more workload for EU national competent authorities. It is investigating why these submissions are not being routed through the mutual recognition/decentralized procedures, which are best suited for such applications.

Europe Regulation
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