PROGRAM OUTLINE

Advanced program for medical advisors

Duration: 2 days

Audience : medical department personnel in pharma industry

• Introduction to medical function in pharmaceutical industry
• Pharmaceutical marketing – guidelines – interpretation
• Regulations for obtaining
  • Marketing permission
  • Clinical trial permission
  • Ethics committee permission
  • Pharmacovigilance reporting
• Protocol and CRF writing
• Introduction to backend of research
  • Datamanagement
  • Statistical programming
  • Medical writing
• Bioequivalence studies

On successful completion of the course, the participant will be able to:

• Review available data and opine on promotional material as per allowed norms
• Understand the nuances of regulatory requirements
• Understand the end to end conduct of a clinical study