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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

How CAR-Ts Are Changing The Lifecycle Paradigm For ATMPs

CAR T-cell therapies have resulted in the industry and regulators exploring unconventional approaches to collecting real-world safety and efficacy data from existing registries. Can this approach also work for other types of cell and gene therapy products in the future? Delegates at a conference in London explored the topic.
Europe Regulation

EMA To Bring Anticancer Drugs Guide Up To Speed With Biomarker Development

Although biomarkers are increasingly being used in oncology to define malignant diseases and develop new treatment strategies, the European Medicines Agency's current guideline on evaluating anticancer drugs does not adequately address these aspects.
Europe Clinical Trials

EMA Antibiotics Guide Seeks To Support Global Development

The European Medicines Agency has proposed changes to its guideline on the evaluation of new antibacterial medicines so as to align some of the data requirements with those in the US and Japan.
Europe International

PIC/S Considers New System For Monitoring Compliance By Members

As more and more regulatory authorities line up to join the informal co-operative scheme for pharmaceutical inspectorates, PIC/S, there are plans to discuss the possible introduction of an annual reporting scheme to check ongoing compliance by existing members.
International Manufacturing

EU ATMP Developers Missing Out By Failing To Use Advice On Offer

Regulators and health technology assessment officials in the EU are disappointed that sponsors of advanced therapy medicinal products are not making good use of the joint scientific advice service, which can help converge regulatory and HTA requirements for these products. 
Europe Regulation

EU Proposes New Guidance On Allergen Products With Small Study Populations

Current EU guidelines for allergen products require sufficiently large numbers of patients to be included in clinical trials, which is not feasible for products being developed to treat patients suffering from low-prevalence allergies.
Europe Regulation
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