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Vibha Sharma

Senior Writer

London, UK
Vibha is a senior writer covering pharmaceutical and medtech regulatory developments across the globe. She plays a key role in tracking and writing about news of important regulatory issues affecting the sectors, and explaining their implications for industry. Vibha's fields of interest include the EU regulations on clinical trials, pharmacovigilance and pediatrics, 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.

Latest From Vibha Sharma

Revised EU Trial Transparency Rules Go Live With Last Minute Changes To Address Confidentiality Concerns

The European Medicines Agency has met the deadline for launching a new version of the Clinical Trials Information System to allow earlier public access to information on authorized studies. However, new concerns raised by commercial sponsors means the publication of certain information fields in CTIS is temporarily suspended.

Europe Clinical Trials

EMA & Health Canada Harmonize Anonymization Reporting For Clinical Trial Reports

Companies submitting clinical data for publication under the European Medicines Agency's Clinical Data Publication policy and Health Canada's Public Release of Clinical Information initiative can now provide a single anonymization report to both regulators. This report would explain the steps taken by sponsors to ensure the anonymized data poses a low risk of re-identification.

Europe Canada

Ireland Should Look To UK & Denmark To Raise Its Clinical Trial Aspirations

Simple, tangible steps taken by the UK and Danish governments to systematically improve their clinical trial environment offer rich learnings for Ireland, which is facing a steady decline in industry-sponsored studies.

Ireland Clinical Trials

Ireland Risks Falling Behind: Urgent Action Needed to Boost Clinical Trials

A new report shows that Ireland attracted fewer industry-sponsored interventional clinical trials than both Finland and Denmark between 2014 and 2023, despite all three countries having a similar population size and economic wealth. 

Ireland Clinical Trials

Global Pharma Guidance Tracker – May 2024

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Guidance Documents Regulation

Global Medtech Guidance Tracker: May 2024

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Sixty-five documents have been posted on the tracker since its last update.

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