Dr. Pragati Gupta

During my internship, I was involved in project management and consulting projects, with the focus on social media intelligence, Change management, communication, training , Marketing.

• Independently conducted literature research for a Non-Clinical and Clinical overview for a Marketing authorization application. • Prepared and revised the dossier structure of drug marketing authorizations (CTD and eCTD). • Created drafts for non-clinical and clinical overviews according to European guidelines. • Provided support for preparation of variations specific for eCTD and data management. • Supported the Manager with comprehensive regulatory guidance on new products and formulations.

• Health Policy, Healthcare System and Regulations. • Market Access, Pricing and Reimbursement. • Health Technology Assessment. • Epidemiology and Applied Statistics. • Pharmacoeconomics Evaluation and Outcomes Research. • Presented coursework on German and Denmark health care system.