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Senior Reporter
UK
6+ years of 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 Pharma Intelligence, 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 18 Jan 2022
The EU will make it mandatory for clinical trial sponsors to prepare layperson summaries of their study results. Industry practices around content presentation, translation and dissemination of these documents will be keenly watched.
Pink Sheet
By Vibha Sharma 22 Apr 2021
A simplified process for registering and evaluating clinical trials promised by the EU Clinical Trial Regulation is finally set to become a reality.
Scrip
By Vibha Sharma 29 Nov 2020
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
By Vibha Sharma 27 Nov 2020
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
By Vibha Sharma 23 Nov 2020
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
By Vibha Sharma 09 Sep 2020
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
By Vibha Sharma 09 Sep 2020
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
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.
Topic Approvals Policy & Regulation
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 & 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 Diseases
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 19 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 05 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 27 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
Medtech Insight
02 Jun 2023
Pink Sheet
22 May 2023
Pink Sheet
18 May 2023
Pink Sheet
15 May 2023
Pink Sheet
05 May 2023
Pink Sheet
02 May 2023
Medtech Insight
02 May 2023
Pink Sheet
26 Jul 2022
Pink Sheet
25 Jul 2022
Pink Sheet
25 Jul 2022
Pink Sheet
22 Jul 2022
Pink Sheet
22 Jul 2022
Pink Sheet
21 Jul 2022
Pink Sheet
21 Jul 2022
Pink Sheet
20 Jul 2022
