Webinar: New Approach Methodologies- NAMs
This event is brought to you in partnership with American Association of Pharmaceutical Scientists’ (AAPS) Women In Pharmaceutical Science (WIPS) Women in Science in India.
Title: New Approach Methodologies- NAMs
Speakers: Dr. KVSN Raju, Dr Seema Kumar and Dr Vibha Jawa
When: 10th August 2026
Where: Online Webinar
Target audience: Scientists, regulators, CRO’s
What will you learn?
NAMs are a broad category of non-animal or animal-sparing scientific methods used to generate safety, efficacy, pharmacology, toxicology, and immunogenicity data during drug development. They are intended to improve human relevance while reducing reliance on traditional animal studies.
In our webinar our speakers will focus on:
1. Integration of NAMs in toxicity testing and drug development, and the current NAMs landscape in India
2. Regulatory expectations and guidance for NAMs (Context of Use, Weight of Evidence, human-based assays, OECD alignment, validation vs. qualification) and alignment across FDA, EMA, and PMDA
3. Novel assay methodologies: scientific, regulatory, and industry perspectives
4. Preparing IND-enabling packages with NAM-based assessments, plus key challenges and recommendations for strengthening the NAMs ecosystem