IPM has been successfully conducting training programmes in Mumbai, with its presence in Dombivli, Borivali & Vashi.

Salient features are:

• Course curriculum based on current approach of regulatory agencies
• Sunday batches, so good option for working professionals
• Experienced industrial faculties
• User-friendly notes based on current guidelines
• Explanation with case-studies
• Group discussion & Quiz sessions
• Evaluation & certification

‘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: