Himakshi Sharma

Individual content contribution and stakeholder management for CTD Modules 2 and 5 majorly including clinical study reports (CSRs), clinical overviews (COs), and clinical summaries for submission to regulatory authorities in support of marketing applications

Project Management: Preparing project proposals and strategy and interaction with the clientele for project requirements and deliverables Project Deliverables: Scientific/health projects such as market access assessment, epidemiological studies, treatment assessment studies, cost of treatment studies for multiple disease areas, access to therapies etc.

Project Responsibilities and Deliverables: CTD Modules 2, 4 and 5 majorly including COs, non-clinical overviews, clinical summaries and non-clinical summaries for generic product filings. Investigator brochures, protocols, safety narratives, and CSRs for USFDA. Summary of product characteristics, patient information leaflets, clinical expert statement for EMEA (generic and innovator) filings and risk management plans. Briefing documents for USFDA submissions

Medicine and Dentistry