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Senior Reporter
UK
+3 year(s) experience
Vibha's fields of interest include the EU Pharmacovigilance legislation and the EU Pediatrics 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.
Pink Sheet
By Vibha Sharma 27 Jan 2020
An EU pilot project will assess whether there is sufficient demand from companies to obtain simultaneous scientific advice from EU national competent authorities.
Pink Sheet
By Vibha Sharma 04 Jul 2019
Four drugs are up for an opinion this week on whether they should be granted EU-wide approval, including Amgen/UCB's osteoporosis drug romosozumab.
Medtech Insight
By Vibha Sharma 25 Jun 2019
The proposed regulatory changes aim to provide Health Canada with greater authority to monitor the safety of marketed devices and to take action.
Topic Policy and regulation
Medtech Insight
By Vibha Sharma 22 Aug 2018
The Canadian government has made it mandatory for hospitals to report medical device incidents and serious adverse reactions in their control irrespective of where these incidents originate.
Topic Medtech
Pink Sheet
By Vibha Sharma 19 Jan 2018
The European Commission's plans to evaluate the EU pediatric and orphan drugs regulation in tandem.
Topic Rare Disease
Medtech Insight
By Vibha Sharma 04 Dec 2017
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker.
Pink Sheet
By Vibha Sharma 20 Oct 2017
Experts at the International Council for Harmonisation have nearly completed the first draft of a guideline
Topic Clinical trials
Pink Sheet
By Vibha Sharma 06 Sep 2017
The European Medicines Agency’s pharmacovigilance committee has recommended the withdrawal of all modified-release paracetamol products from the EU market.
Pink Sheet
By Vibha Sharma 28 Jul 2017
The European Medicines Agency has updated its 2007 guideline on the strategies drug sponsors should apply to identify and mitigate risks in first-in-human trials to provide additional advice on dosing issues and the use of integrated protocols, among other things. The revised guideline will apply from February 2018.
Topic Clinical trials
Pink Sheet
By Vibha Sharma 24 Mar 2017
A new draft guideline from the European Medicines Agency on pharmacovigilance requirements relating to medicines taken during pregnancy and breastfeeding has been delayed and will now be issued for stakeholder consultation by the end of 2017.
Topic BioPharmaceutical
Pink Sheet
25 Feb 2020
Pink Sheet
25 Feb 2020
Generics Bulletin
24 Feb 2020
Pink Sheet
18 Feb 2020
Generics Bulletin
17 Feb 2020
Pink Sheet
13 Feb 2020
Pink Sheet
10 Feb 2020
Medtech Insight
03 Feb 2020
Pink Sheet
12 Dec 2019
Pink Sheet
11 Dec 2019
Pink Sheet
10 Dec 2019
Pink Sheet
09 Dec 2019
Pink Sheet
06 Dec 2019
Pink Sheet
05 Dec 2019
Medtech Insight
03 Dec 2019
