The agenda

Covering:

GLOBAL DRUG SAFETY SETTING

Covering:

RISK MANAGEMENT STRATEGIES

Covering:

SAFETY DATA MANAGEMENT
 

Covering these topics:

SAFETY IN EARLY DEVELOPMENT
CLINICAL SAFETY

Covering these topics:

POST AUTHORISATION SAFETY
SAFETY IN SPECIAL POPULATIONS
DRUG SAFETY: BEST PRACTICE
SAFETY IN LARGE MOLECULES
INFRASTRUCTURE REQUIREMENTS

Covering these topics:

• Background and Overview of Risk Management Activities
• Specific Examples of Risk Management and Minimization Activities
 

How to be fully prepared for pharmacovigilance inspections