4
Interacting with the EMA
There are a number of important meetings that occur during a marketing authoriza-
tion review. Each has specific goals and offers important opportunities to:
• Resolve or ameliorate major CHMP objections
• Demonstrate a positive benefit-risk for a product
• Gain insight into a potential path for obtaining marketing authorization
Effective planning and clear communications are essential for all these meetings.
This book provides a brief overview of the main types of meetings affecting product
authorization and focuses on how to best prepare for these meetings by using the
example of Oral Explanations (OEs), the most common of these interactions.
Interacting with the EMA
There are a number of important meetings that occur during a marketing authoriza-
tion review. Each has specific goals and offers important opportunities to:
• Resolve or ameliorate major CHMP objections
• Demonstrate a positive benefit-risk for a product
• Gain insight into a potential path for obtaining marketing authorization
Effective planning and clear communications are essential for all these meetings.
This book provides a brief overview of the main types of meetings affecting product
authorization and focuses on how to best prepare for these meetings by using the
example of Oral Explanations (OEs), the most common of these interactions.