Mithila Patankar

Managed 100+ MHRA regulatory submissions, including Type IA/IB/II variations, renewals and regulatory queries. Coordinated 10 manufacturing site transfers and MAH updates. Prepared eCTD Module 3 documentation, QOS and reviewed CEPs, DMFs and stability data. Managed 40+ SmPC/PIL and labelling updates, supporting PSUR activities. Collaborated with cross-functional teams on regulatory strategy, change controls, SOPs and lifecycle management.

Provided clinical pharmacy services, including medication reconciliation, patient counselling and adherence support for underserved patients. Collaborated with oncologists and physicians on ADR reporting, treatment reviews, drug interaction assessments and clinical drug information. Led a medication adherence research project under senior oncologist supervision, assessing compliance among 500 oncology outpatients with comorbidities.

Gained insights into the United States healthcare system during one-month observership program. Championed specific strengths and opportunities for improvement within the healthcare systems of India, Japan, and the US during round-table discussions with American and Japanese classmates.

• Involved in providing direct clinical pharmacy services including medication reconciliation, patient counselling, medication adherence to low socio-economic patient groups. • Played a vital role in supporting medical oncologists and physicians, ensuring accurate ADR reporting, comprehensive treatment chart reviews, and timely delivery of drug information and interaction checks. • Implemented a drug compliance project under the guidance of a renowned medical oncologist Dr. Manju Sengar. The project was mai

Core modules- Preclinical Science Advanced Clinical Pharmacology Clinical Drug Development Drug Regulatory Affairs Healthcare Market Place Drug Safety and Ethics Drug Development Statistics and Data Management Design and Evaluation of Medicines for Human Use Biological and Advanced Therapies