20 Things Never to Say to an FDA Investigator Inspired by Vincent F Cafiso the Director of Quality and Regulatory Services at CREO and a former FDA Investigator – presented by Vrushali Negandhi I always look forward to the little anecdotes that Vincent Cafiso shares from time to time. Vincent, the Director of Quality and…
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In the fast-paced world of pharmaceuticals, precision and compliance are paramount. As technological advancements reshape the industry, computer software assurance (CSA) and validation have become critical components in ensuring quality and regulatory compliance. With the advent of artificial intelligence (AI) and other cutting-edge technologies, the landscape of CSA is evolving rapidly. However, these advancements are…
The pharmaceutical industry, a realm of constant innovation and regulatory stringency, has found itself at the crossroads of technology and tradition. In this dynamic landscape, Artificial Intelligence (AI) emerges as a beacon of transformative potential, particularly in quality management. As we embark on a journey through the corridors of Indian Pharma, the question that looms…
Introduction:The Pharmaceutical industry is a highly data sensitive, complex and regulated sector that requires effective and continual innovation. The integration of popular Artificial Intelligence (AI) tools from the open market is not a feasible option for Project Management in the Pharma industry. AI can play a pivotal role in the streamlining processes, enhance decision-making, and…
From Dubai to Global Reach: A candid conversation with Dr. Eman Gomaa, Middle East & Africa MEA Hub Lead, AbbvieIn the bustling heart of Dubai, amidst the vibrant energy of the pharma world, our encounter with Dr. Eman Gomaa was nothing short of bursting inspirations. Her passion for life and work resonated deeply, leading us…
Representing Eminence Group at the recently concluded DHUPHAT 2024 was a thrilling experience. Amidst the buzz and enthusiasm, a common theme echoed through the halls — the growing strength of the GCC pharma market. Manufacturers from across the globe are eagerly eyeing this region for their go-to-market and business expansion strategies.Here are five compelling reasons…
The role of quality management in pharma has evolved into a crucial component, ensuring the highest standards of patient safety and efficacy. Dr. Upendra Quenim, a luminary in the field, leads the way in navigating this ever-changing terrain. In a recent interaction, we explored the role of Quality in Pharmacovigilance through the lens of Dr.…
An Insightful Conversation with Dr. Esraa A. Zoubi, General Manager Advisor for Regulatory and Pricing Affairs at the Jordan Food and Drug AdministrationJordan FDA is the first Arabic regulatory authority, that has well-established regulations that govern drug efficacy and safety. In an exclusive interview with Dr. Esraa A. Zoubi, General Manager Advisor for Regulatory and…
In the wake of the MHRA's safety data review leading to the recall of pholcodine-containing medicines in the UK*, a burning question came to my mind: Could proactive Quality Assurance (QA) practices, including early signal detection and collaboration with healthcare providers for patient insights, have prevented the need for such widespread recalls and averted widespread…
PARABLES OF A PROJECT MANAGERIn one sense, ‘everyone is a project manager’ in an organization. The one who has planned for a vacation has already been in the role of a project manager. When you are planning a vacation, what do we start with? We begin with the destination. Beginning with the end in mind…