Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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.

Set Alert for Articles By Vibha Sharma

Latest From Vibha Sharma

More Time For EU Nitrosamine Evaluations Due To COVID-19

Citing challenges posed by the COVID-19 pandemic, EU regulators have extended the deadline for companies to finish nitrosamine-related risk evaluations.

Coronavirus COVID-19 Manufacturing

Australia Proposes ‘Carving Out’ Certain Software Products From Medtech Regs

The Australian health care products regulator is inviting feedback on proposed measures to clarify the boundary for software-based products that are captured under the regulatory framework for medical devices.

Australia Regulation

COVID-19: EMA Tackles Trial Data Interpretability

A draft EU guideline explains how companies can ensure that data from ongoing clinical trials remains relevant for regulatory decision-making despite problems posed by the COVID-19 pandemic.

Coronavirus COVID-19 Clinical Trials

COVID-19: UK MHRA Says Non-Essential Inspections Will Be Office-Based

The UK’s Medicines and Healthcare products Regulatory Agency is replacing all non-essential on-site inspections with office-based assessments due to the coronavirus pandemic. The agency also plans to rely on information from international regulatory partners to maintain oversight.

Coronavirus COVID-19 Compliance

COVID-19 Vaccines: Global Regulators Define Preclinical Data Requirements

Regulators held a virtual meeting to agree on the type and extent of preclinical data needed to inform the clinical development of vaccines for COVID-19.

Coronavirus COVID-19 Clinical Trials

EU Urges Sponsors To Assess COVID-19 Impact Before Starting New Trials

New EU guidance on managing clinical trials in the context of COVID-19 requires sponsors to critically assess the feasibility of starting a new clinical trial or including new participants in an ongoing trial. A separate survey indicates that patient willingness to participate in new trials has dramatically declined due to the pandemic.

Coronavirus COVID-19 Clinical Trials
See All
UsernamePublicRestriction

Register