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IPA & KDPMA to hold workshop on BA/BE on November 22 in Bengaluru
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Nandita Vijayasimha, Bengaluru
October 25 , 2025
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The Indian Pharmaceutical Association (Karnataka State Branch) and KDPMA (Karnataka Drugs and Pharmaceutical Manufacturers Association) are stressing on the need for industry to be updated on regulatory changes in solid oral dosage forms.
In the BA/BE segment in clinical trials, India thrives on cost-effectiveness and skilled workforce to propel global orders. The country is a prominent location for BA/BE studies due to its competitive costs and availability of qualified professionals. Many Contract Research Organizations (CROs) in the country possess advanced facilities and bioanalytical instruments, meeting international quality standards.
Taking a cue from India’s strong academic and pharmaceutical base, providing a large workforce with expertise in managing clinical trials and bioanalytical processes, IPA and KDPMA are holding a focussed one-day workshop on BA/BE titled ‘Managing Regulatory Changes in Solid Oral Dosage Forms: Technical Insights’. The day-long event will be held on November 22, 2025. Experts from leading pharmaceutical companies and CROs will congregate at the Grand Magrath Hotel, Bengaluru.
Dr. M. Khalid Ahmed Khan, president, IPA Karnataka State Branch told Pharmabiz that this conference was conceived and planned in June keeping in mind the challenges faced by the industry to comply with requirements of Rule 74 and 78 with reference to submission of bioequivalence study data while applying for grant of licence in Form 25/28 for products falling under class II and IV of BCS classification under Rule 2 of the Drugs & Cosmetics Act, 1940 and Rules 1945 in respect to Solid Oral Dosage Forms.
Together IPA and KDPMA have been conducting technical workshops from the last few years for the benefit of industry and academia. IPA has organised workshops on Schedule-M even when it was under the draft stage and also after its implementation in December 28, 2023.
Now bioavailability (BA) is the extent to which a drug is absorbed in the body making it available at the site of action for the desired therapeutic effect. Bio Equivalence (BE) is comparing two products for Bioavailability. Hence, BA studies are crucial in determining the effectiveness of a drug product, he said.
The factors which govern the BA/BE studies in India are regulatory framework, study design and conduct of the studies and documentation. IPA in its endeavour to enhance the compliance of regulatory requirements by the pharmaceutical manufacturers as well as value addition for M Pharm students and research scholars working on such projects has designed this conference, Dr Khan told Pharmabiz.
Experienced professionals who have worked in this specialised area will be sharing their expertise with the delegates. Further, in view of the recent tragedy involving cough syrup with diethylene glycol (DEG) contamination resulting in death of children, a panel discussion on this subject will be highlight of the conference, he said.
A critical segment will spotlight excipient quality in pharmaceutical manufacturing, with focused dialogue on risk mitigation strategies in light of recent diethylene glycol (DEG) contamination incidents, reinforcing the need for robust supplier qualification and analytical vigilance.
Regulatory definitions, BCS-based biowaivers, study design statistical analysis, and ethical aspects of BE trials Role of AI modelling in BE prediction, challenges in special formulations and FDCs will be deliberated.
Sessions will address study design, statistical evaluation, and ethical considerations while exploring bioequivalence challenges in special dosage forms, population variability, and AI-driven modelling. Through practical case studies, the event will highlight real-world regulatory hurdles, post-approval BE requirements, and strategies for effective compliance in a changing global landscape. Through practical case studies, the event will elucidate real-world regulatory hurdles, post-approval BE requirements, and strategic pathways for sustained compliance in a dynamically shifting global landscape.
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