Follow-up queries play a crucial role in pharmacovigilance (PV) by ensuring that adverse event (AE) reports contain complete, accurate, and clinically meaningful information. They help in: Enhan...
The world is rapidly shifting towards personalization—whether in content, commodities, or medical treatments. It is well established that not all treatments work for everyone. However, there is ...
Artificial intelligence (AI) is playing an increasingly important role in pharmacovigilance (PV), transforming how adverse drug reactions (ADRs) are detected, assessed, and reported. There are many to...
Safety data collection is a critical component in the life cycle of any drug, device, or vaccine. In the medical device industry, Individual Case Safety Reports (ICSRs) play a pivotal role in post-mar...
Regulatory clinical writing involves protocol, informed consent documents, investigator brochures, patient diaries, clinical study reports and many more. Apart from therapeutic area and indication spe...
Drug safety begins at the conception of drug molecule. Collection of adverse events during clinical development phase plays major role in determining initial safety profile of the drug to be presented...
Development of Medical devices has its own challenges that have become more complicated due to complexity of devices themselves having have multiple different constituent parts, including hardware, so...
Community pharmacovigilance has always been neglected area by researchers. Importance of drug knowledge and its side effects has never been thought from the school age. Drugs being important part of l...
Vendor activities are always of prime importance in pharmacovigilance. They are scrutinized very thoroughly by regulatory agencies. Guidelines are very clear about compliance expectations about vendor...
Medical writing has always been my passion. After all these years of experience, when I reflect back, I always feel gratitude towards almighty for giving me all those experiences across all my job fun...
GxP is an acronym for the group of good practice guides governing the preclinical, clinical, manufacturing and post-market activities for regulated pharmaceuticals, biologics, medical devices, etc., s...
Despite the numerous scientific, technological, and operational advances in R&D that would be expected to increase the efficiency and success of drug development, a significant number of clinical ...
Few years back, there was no much compartmentalization in clinical research departments of majority of pharmaceutical companies. One person used to write protocol & related documents, select sites...