Pharma

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

Rich with practical insights and real-world applications

Global regulatory bodies' inspection frameworks

Global regulatory bodies' inspection frameworks

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

 How to implement increasing challenges using ICHQ7

 How to implement increasing challenges using ICHQ7

Understanding of PK parameters

Use of PK: drug-drug interaction, bioequivalence, PK/PD..

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.

Rich with practical insights and real-world applications

Considerations for the USA and Europe

Root causes for nitrosamine impurities

Managing CMOs with condence, insight and understanding

Key points for successful development and registration of products in US