Program learning goals

• Knowledge of the regulatory requirements for the different phases of drug development, before and after product approval*, on a global level, emphasising on Europe.
• Skills to plan, project manage and carry out the regulatory work to support optimized drug development, product safety and availability on the market and ensure that the companies meet the regulatory requirements set by authorities.
• Competence to interpret and analyse the regulations to be able to both operate and advise during the different phases of drug development before and after product approval*.
*Medicines Agency authorisation to market a medicinal product in a specific country.

Included courses

• Biologics Drug Development / Drug Development
Instructor lead course, 3 days
• Basics of Regulatory Affairs
Instructor lead course, 3 days
• Introduction to Life Science
e-learning, 2 hours
• Introduction to Advanced Therapies - ATMP
e-learning, 15 minutes
• Combination Products for Pharma - Device Perspective
e-learning, 2 hours
• Nordic Market Access
e-learning, 2 hours
• Kemisk farmaceutisk dokumentation 
on demand or live in Stockholm, 2 days
• Regulatory documentation, content and format guide
Instructor lead course, 1 day
• Regulatory Strategies
Instructor lead course, 2 days
• GDP Basic
e-learning, 2 hours
• Marketing and ethical compliance - an overview
e-learning, 3 hours