Pharma

Rich with practical insights and real-world applications

Rich with practical insights and real-world applications

Major types of adaptive trial designs

Principles, advantages and potential challenges of the adaptive design methodology

Inspection readiness

Establishing, Maintaining and Demonstrating Sponsor Oversight

Best practices, new responsibilities and opportunities

Best practices, new responsibilities and opportunities

Global regulatory bodies' inspection frameworks

Global regulatory bodies' inspection frameworks

Decentralized Clinical Trial

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.

Bridging Science, Compliance, and Patient Safety

Bridging Science, Compliance, and Patient Safety

RBQM principles that align with regulatory expectations

RBQM principles that align with regulatory expectations

Key components of tissue engineering

Key components of tissue engineering

Considerations for the USA and Europe

Considerations for the USA and Europe

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

Managing CMOs with condence, insight and understanding

Key points for successful development and registration of products in US