The Indian pharma sector is poised towards an unrivalled technological transformation of the century, most sought-after and most talked-about. Globally ranking third in drug product manufacture, especially of generic medicines and vaccines, this “Pharmacy Capital of World” continues to grow at a phenomenal rate, amid inimitable opportunities and formidable challenges. The current pharma upsurge calls to update ourselves on the evolving technological paradigms and newer regulatory requirements for ensuring leading-edge patient-centric quality drug products. Holistic and systematic development of drug products and analytical methods using modern QbD models, has accordingly become an ardent need of the hour, not merely to comply with regulatory requirements, but to attain pharma quality excellence too. Adoption of ICH (Q8 to Q14) guidelines have further reinforced the inevitability and vitality of implementing such QbD-associated principles today. With the advent of newer disruptive approaches like non-invasive tools for process analytical technology (PAT), generative AI/ML, big data analytics, IoT, organ-on-a-chip and precision medicine, the domain of such paradigms is lately getting far more widened and diversified, including in continuous manufacturing, API production processes and herbal drug extraction technology. Scientists, therefore, have to acquire abilities to understand such innovative and productive practices, and their pragmatic utility towards optimal benefit to all the patients, researchers and regulators. Download Brochure
This Symposium-cum-Workshop is strategically designed to provide the multi-faceted knowledge and know-how in interdisciplinary science through deliberations, discussions and hands-on training sessions with the designated experts. Besides familiarizing the participants on the ongoing trends and techniques of QbD fundamentals over the entire product development cycle, viz. product and process optimization using Design of Experiments (DoE) and Quality Risk Management (QRM), the sessions will also touch upon advanced QbD applications, including PAT and chemometric tools. It would offer an ideal opportunity for the novice scientists to gain familiarity with diverse conceptual and practical aspects of these contemporary realms, especially on resolving the relevant computational issues.
The prime objective of the program is to apprise and update the young participants among faculty, researchers and industry on diverse scientific and professional vistas pertaining to Pharma QbD and related paradigms. Besides the fundamental principles, implications and applications, this Symposium would also embark upon pertinent precepts and practices employed for systematic development of wide-ranging drug delivery technologies and analytical processes, and relevant computational tools for their requisite implementation. The proposed Symposium would provide a conducive milieu for the aspiring scientists to explore and exploit the potential role of various approaches and appliances necessary to attain proficiency in the updated QbD-related domains, while interacting face-to-face with the deft professionals, duly trained and experienced in the area.
The Symposium-cum-Workshop would comprise of a gamut of well-conceived offline lectures by a galaxy of eminent experts in the field, from India or beyond, who would demonstrate vanguard tools and techniques for inclusive development of QbD-enabled pharmaceutical products and processes, to result in effectual and cost-effectual outcomes. Hands-on training workshop sessions will be provided by an adroit company expert from JMP Statistical Discovery (Subsidiary of SAS Inc., USA), on one of the most globally popular, versatile, interactive, comprehensive, intuitive and powerful statistical software platforms, ‘JMP’. Participants must download the trial version of JMP software from https://www.jmp.com/try on their laptops for the purpose. Select faculty members and research students may also be provided with annual complimentary JMP licenses as part of their academic collaboration.
- Formulation by Design ( FbD)
- QbD Tools, Techniques & Trends
- QbD in Herbal Drug Extraction
- Novel Drug Delivery
- Analytical QbD
- QbD in API Productivity
- Drug Regulatory Aspects
- Analytical Method Development