Pharma - Masterclass

Rich with practical insights and real-world applications

Rich with practical insights and real-world applications

PSMFs purpose, structure, and regulatory requirements

PSMFs purpose, structure, and regulatory requirements

Regulatory requirements, sources, responsibilities, characterisation, management, and use

Root causes for nitrosamine impurities

Inspection readiness

Establishing, Maintaining and Demonstrating Sponsor Oversight

XRPD, DSC/TG, Raman mapping, PSD assessment, and SEM/EDS

Anticipate bioequivalence risks and optimize formulations

Broader framework of QMS

CAPA development and decision-making

Bridging Science, Compliance, and Patient Safety

Bridging Science, Compliance, and Patient Safety

Understanding of PK parameters

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

The course will cover serialisation and aggregation of medicinal products

The course will cover serialisation and aggregation of medicinal products

Root causes for nitrosamine impurities

Fundamentals up to a deep understanding of underlying concepts

Understanding the PK/PD relationship

Today, process validation comprises three main steps

Deeper understanding on how process validation for biotechnological processes

Building Biorelevant & Discriminatory Methods Regulators Trust

Building Biorelevant & Discriminatory Methods Regulators Trust

Impurities: from A to Z

Impurities: from A to Z

Applied Toxicology and its critical role in the therapeutic development lifecycle

Toxicology and GLP

Key points for successful development and registration of products in US

Key points for successful development and registration of your pharmaceutical products

Managing CMOs with condence, insight and understanding