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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.



Latest From Vibha Sharma

Takeda Test Drives EMA’s Parallel Review Route For EU And Non-EU Markets

A new evaluation route that the European Medicines Agency launched last year came at the right time for Takeda’s dengue vaccine candidate. 

Review Pathway Vaccines

EMA’s Revised Guide On Additional Risk Minimization ‘Overly Detailed’

Executive Summary: The European pharma industry federation believes the advice provided in the updated draft EU guideline on additional risk minimization measures is far too detailed, resulting in a lack of focus, information overlap and confusion.

Europe Drug Safety

ICH Plans New Guideline On Pharmacoepidemiological Studies Using RWD

At its latest meeting in June, the International Council for Harmonisation agreed on new topics that could benefit from harmonized advice and took note of progress made on drafting and finalizing quality, safety and multidisciplinary guidelines.

International Guidance Documents

US Survey Shows Pharma More Open To Remote Patient Monitoring

COVID-19 is driving changes to how clinical trials are being conducted in the US, with 44% of respondents who participated in a recent survey saying they have adapted or plan to become decentralized in coming months.

United States Clinical Trials

Combined Trial Reviews To Become The Norm In UK From 2022

Having gained enough experience with the combined ethics and regulatory review of clinical trial applications, the UK will make this its only route for evaluating new drug trial applications starting next year.

United Kingdom Clinical Trials

Plans For EU Electronic Product Information Move Up A Gear

Stakeholder agreement on the technical features of electronic product information (ePI) will pave the way for launching a proof-of-concept exercise and a roadmap on how ePI will be rolled out in the EU.

Europe Regulation
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