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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

Sanofi Genzyme’s Treatment For Pompe Disease On Track For EU Approval

EU reviewers have recommended marketing approval for two new medicines, but have turned down another product. 

Europe Drug Review

EU Decision Time On Broader Indication For AbbVie’s Skyrizi

The European Medicines Agency is meeting this week to consider applications to broaden the use of approved drugs to include new indications in the EU. 

Drug Review Regulation

Intercept Wants More Time to Address EMA’s Questions Over Its NASH Treatment

The marketing application for obeticholic acid, Intercept’s potential new treatment for advanced fibrosis due to nonalcoholic steatohepatitis (NASH), was rejected in the US and now the company says it needs extra time to respond to questions about its EU filing.

Drug Review Liver & Hepatic

Kyowa Awaits EU Decision On Drug For Treating Parkinson’s ‘Off’ Time

The European Medicines Agency is meeting this week to decide whether two new drugs, including one that enhances anti-parkinsonian activity, should be approved for use in the EU. Also, the sponsor of a treatment for the rare degenerative muscle disorder, Pompe disease, is expected to attend an oral explanation meeting to address last-minute questions.

Europe Drug Review

PIC/S Advises On Safe On-Site Inspections During COVID-19 Pandemic

The international association of pharmaceutical inspectorates, PIC/S, has developed a structured process that national inspectors can use to assess their risk of exposure to COVID-19 when carrying out routine on-site inspections.

Coronavirus COVID-19 Guidance Documents

EMA Considers How To Verify Potency Of Next-Generation COVID-19 Vaccines

Companies approaching the European Medicines Agency with their development plans for new COVID-19 vaccines are being asked to consider immunobridging studies if placebo-controlled trials are not feasible.

Vaccines Coronavirus COVID-19
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