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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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ICH To Fix Inconsistencies With RCTs, Address Use Of Alternate Designs And Data Sources

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.

Regulation Clinical Trials

How EMA’s Adaptive Pathways Fits Into The Complex Drug Pricing Puzzle

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.

Regulation Reimbursement

EMA Review Of Non-EU Drugs To Be Made More Useful For African Regulators

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.

Regulation Middle East and Africa

Belgium To Test Parallel Review Of Clinical Trial Dossiers Ahead Of New Regulation

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.

Regulation Clinical Trials

Legal Change Beckons After EU Active Substance Master File Pilot Success

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.

Regulation Europe

More Manufacturers Sign Up For Single Audits As MDSAP Becomes Operational

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.

Quality Control Compliance
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