Check events - Masterclass

Rich with practical insights and real-world applications

Rich with practical insights and real-world applications

Key points for successful development and registration of products in US

Key points for successful development and registration of your pharmaceutical products

Development and validation of bioassays

Development and validation of bioassays

ESG impacts on market, credit, and liquidity risk studies

Developing established model approaches!

 FDA and EMA pediatric decisions

 Pediatric Drug Development (PDD) is a controversial matter!

Increase the likelihood of studies receiving regulatory approval

Design stability studies suitable for global marketing

Applied Toxicology and its critical role in the therapeutic development lifecycle

Toxicology and GLP

Technical depth and practical application

Digital Twins and Digital Threads for modern manufacturing

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

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

Inspection readiness

Anticipate bioequivalence risks and optimize formulations

Establishing, Maintaining and Demonstrating Sponsor Oversight

Understand how the EUs sustainable finance framework works

Deep-dive into EU sustainable finance and sustainability reporting

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..

Building Biorelevant & Discriminatory Methods Regulators Trust

Building Biorelevant & Discriminatory Methods Regulators Trust

Managing CMOs with condence, insight and understanding