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
The European Medicines Agency has for the first time explicitly stated it is considering the use of large language models as a tool to improve the readability of a scientific guideline.
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.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. 25 documents have been posted on the tracker since its last update.
The policy expectation that the model clinical trial agreements are used without modification is in line requests from industry and the NHS/HSC.
Efforts by the medicines regulator, the MHRA, to clear all backlogs relating to its statutory functions and maintaining predictable review timeframes have put pressure on its staff.
The European Medicines Agency’s assessments of applications for variations play a key role in supporting international regulatory reliance mechanisms. Companies can aid this by ensuring the scope of their post-approval changes is clear, and notifying the EMA when sharing reports with non-EU regulators.