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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
The Medicines and Healthcare products Regulatory Agency has put procedures in place to renew UK marketing authorizations that are grandfathered from the EU system after the Brexit transition period ends.
Topic EU Pharma-Brexit Brexit
Pink Sheet
The UK’s approach to pharmacovigilance system requirements in the post-Brexit transition period will allow companies to leverage some of the existing structures put in place for EU systems.
Topic Pharma-Brexit Brexit
Pink Sheet
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
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
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
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
The European Commission's plans to evaluate the EU pediatric and orphan drugs regulation in tandem.
Topic Rare Disease
Medtech Insight
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker.
Pink Sheet
Experts at the International Council for Harmonisation have nearly completed the first draft of a guideline
Topic Clinical trials
Pink Sheet
The European Medicines Agency’s pharmacovigilance committee has recommended the withdrawal of all modified-release paracetamol products from the EU market.
Pink Sheet
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
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
20 Oct 2020
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19 Oct 2020
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16 Oct 2020
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15 Oct 2020
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05 Oct 2020
Medtech Insight
01 Oct 2020
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30 Sep 2020
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28 Sep 2020
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25 Sep 2020
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24 Sep 2020
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22 Sep 2020
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21 Sep 2020
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21 Sep 2020
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17 Sep 2020
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16 Sep 2020
