PharmaPreneurship: Strategies for Building a Successful Business in the Pharmaceutical Sector

• When: Thursday: 07/08/2025
• Where: Seminar Hall, 3Rd Floor, MCOP, Nigdi, Pune – 44
• Duration: 11.30 AM To 12.30 PM
• Theme: Guest Lecture’s 2025 – 26

The guest lecture provided T Y B Pharm students with a comprehensive, industry-focused overview of the Regulatory Aairs (RA) function. Mr. Gundecha dened RA as a strategic role critical to ensuring patient safety and product quality throughout the pharmaceutical lifecycle. Core topics addressed included: Drug Development Lifecycle: Emphasis on the protracted timeline (up to een years) and the necessity of early-stage RA guidance to mitigate risks and save resources. Documentation Standards: Detailed discussion on mandatory submissions for market authorization, including the Common Technical Document (CTD/eCTD), Investigational New Drug (IND) applications, and New Drug Applications (NDA). Global Compliance: The critical importance of adhering to global quality standards, especially GMP, GLP, and GCP. Career Prospects: Practical guidance on the vast career opportunities in RA and the essential skills required, such as critical thinking and effective documentation. The session was highly engaging, utilizing real-world case studies to illustrate regulatory importance. Students from Third year B Pharm Divisions A & B actively participated, specially inquiring about challenges related to biosimilar approval and global regulatory harmonization. The seminar successfully equipped students with a pragmatic and career-relevant understanding of the pharmaceutical industry's most vital safeguarding function.