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 launched a phased initiative to consolidate the wide array of training materials for the Clinical Trials Information System, aiming to eliminate duplication, ensure consistency, improve accessibility and enhance user-friendliness.
Study sponsors looking for guidance on how the simplified informed consent provisions will be implemented under the new UK clinical trials legislation will have to wait longer. The Health Research Authority is looking at what safeguards are needed to address the “range of concerns” stakeholders had regarding its initial proposal.
A first-of-its-kind review of clinical trial applications submitted to the UK medicines regulator, the MHRA, shows there is a concentration of research in certain disease areas and identifies opportunities to enhance the representation of specific patient groups.
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. Over 40 documents have been posted on the tracker since its last update.
The new global GCP guideline, ICH E6(R3), enables researchers and clinical trial administrators to tailor their documentation processes, but also opens the door for more scrutiny during GCP inspections.