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If you work in generic pharma portfolio management, chances are you spend epic amounts of time locked up with a spreadsheet the size of a small continent. Molecules and dosage forms, therapeutic areas, sales channels, market shares, LoE dates, patent minefields to traverse, bioequivalence complexities, API costs and dossier suppliers, capacity constraints and on, and…

William Shaksphere once said, “What’s in a name?”. He meant to tell us that the true essence of something can never be captured by just its name.While that certainly applies to people, the case is not necessarily the same for medicines. Have you ever wondered why medicine names are so complex and difficult to pronounce,…

Reinforcing the Importance of PV and ADR ManagementWhat are the odds of getting killed by a cough syrup? For most of us, this sounds impossible. Yet, this has become today’s reality. More than 20 children in India have died not from a deadly disease, but from a spoonful of cough syrup given for the flu.…

Artificial Intelligence (AI) and tools like ChatGPT have become the defining forces of our era. From boardrooms to classrooms, from manufacturing to personal assistants, their influence is undeniable. Yet, as with any transformative technology, the story is not one-sides, it carries both immense benefits and looming threats.The three images- the original picture, the Ancient Greek…

One of the main barriers to adopting Computer Software Assurance (CSA) is the established culture surrounding Computer Systems Validation (CSV). For an extended period, validation teams have frequently associated compliance with documentation volume; larger validation packages have been seen as indicative of compliance. As a result, professionals familiar with producing and reviewing detailed test scripts…

As someone who has spent many years working across different regions and regulatory environments, I can say that the pharmacovigilance (PV) landscape in the Rest of the World (RoW) is quite complex and diverse. Unlike the US or Europe, where regulations are well-established and enforcement is consistent, many countries in the RoW are still developing…

In the rapidly evolving field of pharmacovigilance, maintaining a robust Quality Management System (QMS) is critical, not only for ensuring regulatory compliance and safeguarding patient safety, but also for driving continuous improvement. With over two decades of experience in drug safety and clinical research, I’ve learned that the success of a QMS is not solely…

#EminenceDigitalDetox: Breaking ‘I would rather check my phone than face my problems’ attitude.Studies show that individuals check their phones over 100 times a day, leading to feelings of anxiety, distraction, and disconnection from the present moment. This year, in response to these growing concerns, we ran an experiment at our work place, after witnessing a…

Many developments in silica particles used in liquid chromatography (LC) have been well documented over the years. The move from irregular silica to spherical silica, the decrease in particle size from >5µm particle in high performance liquid chromatography (HPLC) to sub-2-µm particle size in ultrahigh-pressure LC (UHPLC), the improved silica purity of type B silica…