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Senior Reporter
UK
+4 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.
Scrip
Could Serum Institute or Bharat Biotech be the first company to have a COVID-19 vaccine for children under 12 years of age? While Pfizer and Moderna have begun pediatric trials for children 12 years and above, Serum plans to begin testing its indigenous vaccine and Bharat Biotech its Covaxin in children under 12
Topic Coronavirus
Scrip
Oxford University/AstraZeneca’s COVID-19 vaccine cuts the spread of the virus by 60%, apart from having 70% efficacy in reducing infections in vaccinated individuals. While that is good news for their Indian partner, Serum Institute, the 90% efficacy shown in a subset due to a dosing error causes a dilemma.
Topic Coronavirus Vaccines
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.
Topic EU Innovation Regulation
Pink Sheet
With still no guarantee of what kind of access the UK will have to the EU’s all-important Article 57 database after the Brexit transition period ends, drug companies will have to provide key information about their pharmacovigilance systems directly to the UK medicines regulator.
Topic Pharma-Brexit Safety Brexit
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
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.
Topic Approvals Policy & Regulation
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
09 Apr 2021
Generics Bulletin
07 Apr 2021
Medtech Insight
06 Apr 2021
Generics Bulletin
31 Mar 2021
Pink Sheet
31 Mar 2021
Pink Sheet
30 Mar 2021
Pink Sheet
09 Mar 2021
Medtech Insight
04 Mar 2021
Pink Sheet
01 Mar 2021
Pink Sheet
25 Feb 2021
Pink Sheet
24 Feb 2021
Pink Sheet
19 Feb 2021
Medtech Insight
18 Feb 2021
Pink Sheet
17 Feb 2021
Pink Sheet
16 Feb 2021
