Pharma

Rich with practical insights and real-world applications

Rich with practical insights and real-world applications

Development and validation of bioassays

Development and validation of bioassays

A holistic approach and practical examples on the connection between signal/risk management with benefit risk and PBRERs

Emerging safety issues (ESISs) and other safety communications (i.e. DHPCs)

Key points for successful development and registration of your pharmaceutical products

Learn how to define, evaluate, and respond to risks, and also how to define critical data.

Learn how to define, evaluate, and respond to risks, and also how to define critical data.

Root causes for nitrosamine impurities

From concepts to strategic implementation

From concepts to strategic implementation

Major types of adaptive trial designs

Establishing, Maintaining and Demonstrating Sponsor Oversight

Inspection readiness

Global regulatory bodies' inspection frameworks

Global regulatory bodies' inspection frameworks

Better understanding of AI applications to Dermatology and Healthcare

Better understanding of AI applications to Dermatology and Healthcare

Conduct successful Pharma Licensing Negotiations

Conduct successful Pharma Licensing Negotiations

Impurities: from A to Z

Connection between risk management with PBRERs and benefit-risk assessment and tools

A comprehensive overlook on benefit risk assessment in PSUR and RMP

The general requirements for small molecules and biologics.

Considerations for the USA and Europe

Considerations for the USA and Europe

Managing CMOs with condence, insight and understanding

Key points for successful development and registration of products in US