Sangita Mishra
Rearcher, Department of Pharmaceutics · JSS College of Pharmacy, Mysuru
Research Interests
Health Policy, Rare Diseases, Regulatory Science
Biography
I have completed my PhD research from JSS College of Pharmacy, Mysuru, India, specializing in Health Policy and Regulatory Sciences. I hold a Masters in Microbiology from Calcutta University. My research focuses on the clinical and regulatory aspects of orphan drugs, with a particular emphasis on global clinical trials, policies, regulations, and therapeutic management. My research has resulted in two international publications as the first author in the Orphanet Journal of Rare Diseases, exploring orphan drug trials in the EU and rare disease management in India. Additionally, I have co-authored several other publications on orphan drug pricing in the USA, pharmacoepidemiology, and regulatory aspects of therapeutics in various geographies. My ongoing studies include assessment of cell and gene therapy products usage and effectiveness for rare disease treatment in India and review of ongoing pharmacoepidemiological studies in India to inform health policy planning. I am keen in conti
Education
MSc, PhD
Recent Scopus Publications
- Regulatory Pathway for Genotoxic Impurities in Europe, US, Canada, India, Australia and UK
- Regulatory Prospects for Stem Cell in Clinical Trials: UAE, US, and India
- Rare disease clinical trials in the European Union: navigating regulatory and clinical challenges
- Navigating health policies and programs in India: exploring opportunities to improve rare disease management and orphan drug research
- Navigating the mammography quality standard act in USA: Role of US FDA and future scopes of regulation
Links
- ORCID https://orcid.org/0000-0002-7879-5259
- Google Scholar https://scholar.google.com/citations?hl=en&user=kG6f90MAAAAJ
- Scopus https://www.scopus.com/authid/detail.uri?authorId=58173082400