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
The International Council for Harmonisation has proposed major changes to its good clinical practice requirements in a bid to allay concerns about the problems they pose in conducting well-designed randomized trials. The revised GCP framework would also address the increasing diversity of clinical trial designs and data sources.
The European Medicines Agency’s adaptive pathways concept may have a role to play in reducing the prices of medicines. But early market access initiatives such as these are just one piece in the complex drug reimbursement puzzle.
The European Medicines Agency is looking into how it can better promote the Article 58 procedure under which it evaluates the quality, safety and efficacy of medicines or vaccines intended for use outside the EU. The procedure has been underutilized by industry to date and the EMA wants to encourage its use, especially for drugs to be used in Sub-Saharan Africa.
Belgium is following the footsteps of Germany and France by launching a pilot to develop and test procedures for the coming EU Clinical Trial Regulation, which requires national competent authorities and ethics committees to evaluate trial dossiers in parallel and to issue a consolidated single decision within short timelines.
A voluntary pilot that allowed EU regulators to share their assessments of active substance master files (ASMFs) has been a success. Efforts are now underway to change the EU legislation to establish the ASMF as a stand-alone document in order to permit such work sharing on a mandatory basis.
A growing number of medtech manufacturers have expressed interest in the Medical Device Single Audit Program since MDSAP became fully operational in January. The program has also drawn interest from regulatory agencies beyond those from the five participating countries, and a policy is being framed to admit new members.