Course Description

The program provides a broad overview of the current standard drug development process and offers insights into future trends
Topics:

• Global Drug R&D and the Pharmaceutical Business Environment
• The Life Cycle of a Drug: from Bench to Bedside
• Regulatory Strategy and Approval Process

Content

Module 1: Global Drug Research & Development and the Pharmaceutical Business Environment
Key topics:

• Principles and organisation of global pharmaceutical research and development
• Pharmaceutical business environment: innovation in discovery and development as a response of the market needs
• Trends in the pharmaceutical and biotech industry
• Intellectual property and patenting
• Innovative tools: artificial intelligence, big data, precision medicine

Module 2: The Life Cycle of a Drug: Taking a Molecule into Humans
Key topics:

•  Life Cycle Management
•  Building and selecting a successful drug candidate
• Translational science: from animal to human
• Safety and efficacy testing
• Impact of genomic disposition
• Target Product Profile

Module 3: Global Registration and Market Access
Key topics:

• Regulatory processes and practices around the world
• Most important regulatory authorities: FDA, EMA, PMDA etc.
• Pharmacovigilance: reporting and surveillance system
• Market access: pricing and re-imbursement
• Medical Products Regulatory Processes and practices in the different regions of the world
   

Course Language

English

Course Credits

You can earn 1 ECTS point with this free e-learning by submitting a homework assignment.

Course Fee

Free

Course Organizer

This course is organized by the European Center of Pharmaceutical Medicine.

Create an account to begin this e-learning course: https://learn.ecpm.ch/login/signup.php