‘Diploma in International Business Development’
Objective: To acquaint the candidate with the Regulatory, administrative and commercial aspects of Pharma Business Development.
Course Highlights:
- Module 1
• Indian Pharma Overview
• Business Development profession- Role & responsibilities, Concept & strategies, Role of commercial agents
• Business agreements- Confidentiality Disclosure Agreements, Supply Agreements, License Agreements
• Cost calculation & Pricing
• Budgeting and annual target setting
• Tools for Account management – Customer Relationship Management, Key Account Management
- Module 2 [Introduction to the below topics]
• Patents: US: Hatch-Waxman law- Significance, Features, 180 day exclusivity, Orange
Book, ANDA certification rules, Europe: Patent scenario, Data exclusivity,
Emerging markets: Latin America, ASEAN market, Planning market entry based on Patent scenario
• Product development & Technology transfer
• ICH guidelines, Regulatory agencies, Regulatory documents –CTD format, ACTD format, Dossiers, DMF, Open and closed parts of DMFs, Tech Packs
• Product Registration procedures- US, Eu, ASEAN: Malaysia, Singapore, Latin America: Colombia
• Change control and managing changes with customers, Regulatory InspectionsEligibility: Graduate/BPharm/Mpharm/MBA/Working ProfessionalsDuration: 8 Sundays, [10am – 3pm]Commencement date:
Branches |
Dates |
Borivali |
June 2015 |
Thane |
June 2015 |