What you will learn
- The basic regulatory requirements for pharmaceutical products in the post-approval phase and regulations concerning pediatrics, risk management plans, referrals and generics
- How and when to apply for variations for CMC changes, labeling updates, SPC updates and renewals
- How to analyze and evaluate regulatory concerns and risks in life cycle management using relevant regulations, guidelines and best practices in order to maintain regulatory compliance
- How to advise and decide on the optimal regulatory strategies for life cycle management projects
What your company will get
- A regulatory professional who understands the basic regulatory requirements for a pharmaceutical product in the post-approval phase and the regulations concerning pediatrics, risk management plans, referrals and generics
- A regulatory professional who knows how and when to apply for variations
- A regulatory affairs professional who is able to analyze and evaluate regulatory concerns and risks in life cycle management and knows how to be regulatory compliant
- A regulatory affairs professional who is able to advise and decide on the optimal regulatory strategies for life cycle management projects