Overview

Navigating the highly regulated markets of the US and Europe with complex generic injectables is a monumental challenge that requires a deep understanding of evolving regulatory frameworks and technical excellence. Unlike simple generics, these products, which include nanosuspensions, liposomes, and complex drug-device combinations, often lack a clear regulatory pathway. This necessitates a proactive approach where developers engage with agencies like the FDA and EMA early on to align on development strategies and data requirements. Demonstrating "sameness" or bioequivalence is not straightforward and often requires a combination of advanced physicochemical characterization, in vitro release testing, and sometimes, even comparative clinical studies. The goal is to provide a comprehensive, model-integrated evidence package that not only meets but anticipates regulatory expectations, ensuring a faster and more predictable route to market approval. This strategic navigation is key to unlocking the immense value of these products and increasing patient access to affordable, high-quality treatments.

InjectablesX (Complex Injectables for Highly Regulated Markets) is meticulously crafted for R&D scientists, formulators, analytical experts, regulatory professionals, process development as well as manufacturing personnel who are at the forefront of developing next-generation parenteral products. Our agenda is a comprehensive exploration of the entire product and production lifecycle, from initial portfolio selection and rational formulation design to advanced characterization and rigorous bioequivalence studies. We will tackle the complexities of portfolio management for injectable generics and demystify the challenges in lifecycle management. Discover the secrets of reverse engineering innovator products and master "fit for purpose" characterization techniques for complex APIs and excipients. The conference will feature dedicated sessions on the rational design of intricate delivery systems, including long-acting injectables, nanomaterials like liposomes and self-assembling nanotubes, and cutting-edge drug-device combination products. You'll gain practical insights into the latest in vitro dissolution and release testing methods, including establishing crucial in vitro-in vivo correlations (IVIVC).

Beyond formulation, InjectablesX will address the critical aspects of manufacturing and quality control. Learn about robust process control strategies for ensuring sterility, explore the role of specialized equipment in aseptic environments, and understand how to mitigate human error through effective training. We will also explore the transformative potential of AI/ML and digitalization in modern injectable R&D. Join us at InjectablesX to stay ahead of the curve, build invaluable connections, and shape the future
Embark on a journey into the future of pharmaceutical innovation with InjectablesX, a premier technical conference dedicated to advancing the science of injectable complex generics. Join us in Ahmedabad on January 29-30, 2026, for two days of intensive knowledge exchange, collaboration, and extensive research into the technical intricacies that define this high-growth sector.

Please note that photography/videography of the scientific contents presented at the conference is strictly prohibited. We will share the presentations with the delegates only if provided and allowed by the respective speakers.