Register for our free email digests:
Vibha Sharma
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.
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.
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.
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.
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.
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.