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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

EU Decision Time On Expanded Use Of BMS/Ipsen Pharma Cancer Drug Combo

The European Medicines Agency may decide this week on a dozen requests by companies seeking new uses of their approved drugs.

Drug Review Approvals

EU Regulators Take A Practical Approach To Addressing Nitrosamine Contamination

Regulators in the EU have decided on specific arrangements they plan to employ if sponsors detect and report nitrosamine impurities in their products being sold on the market.

Manufacturing Drug Safety

EMA Shifts Gear On Patient Feedback During Drug Review

The European Medicines Agency is exploring the feasibility and utility of contacting patients’ organizations for their input as soon as its medicines evaluation committee starts reviewing a new drug.

Europe Regulation

New Australian Guide Explains Oversight Of Clinical Decision Support Software

The Australian medtech regulator is urging sponsors of clinical decision support software to review their products to determine if these are regulated, exempted or excluded from regulatory oversight. Much depends on the intended purpose of these products, as stated by the manufacturer.

Australia Regulation

EMA Clarifies GCP Inspector Authority Over Accessing Patient Records

Data from non-EU trials may be turned down by the European Medicines Agency if sponsors fail to obtain prior consent from participants agreeing to their personal medical records being accessed by inspectors.

Europe Clinical Trials

Enhertu Nabs A First With UK Standalone Approval

The UK conditional approval of Daiichi Sankyo/AstraZeneca’s advanced breast cancer drug Enhertu was issued in accordance with “transitional provisions” that apply to drugs that received a positive opinion from the European Medicines Agency before the end of the Brexit transition period.

Cancer Review Pathway
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