International Business

Regulatory aspects of International Pharma Business [ US, Europe, WHO ]

Objective: To acquaint the candidate with regulatory aspects of International Pharma Business


  • 4 Saturdays, 10 to 3:30 pm
  • Lectures will be conducted at Thane
  • Faculties: Subject Matter Experts from industry
  • Course material: Presentation handouts will be provided
  • Certificate of participation will be awarded

Syllabus highlights:
Section 1

  • Regulatory terminologies, Factors affecting regulatory business
  • Introduction to ICH guidelines & RA documents, Managing changes with customers

Section 2: US: Requirements of market entry to US, databases, activity flow-chart, patent scenario, types of applications, inspections- impact of outcome on business

Section 3: Europe

  • Requirements of market entry to Europe, CEP, ASMF, Inspections, Regulatory databases
  • Patent scenario, Data and market exclusivity, Role of agents, Qualified persons
  • Marketing authorization procedures

Section 4: WHO Prequalification programme

  • Activity flow chart from submissions, review with timelines, financial aspects
  • Submission & approval with time-lines, EOI