Pharma - Masterclass

 Understand the values of PK/PD studies in drug R&D from an industrial perspective

Optimizing drug development and translational medicine strategies

The latest revision to ICH GCP

Design stability studies for global marketing

Increase the likelihood of studies receiving regulatory approval

Inspection readiness

Establishing, Maintaining and Demonstrating Sponsor Oversight

Tools, Techniques, and Compliance

A phenomena for complex therapeutics

Rich with practical insights and real-world applications

This online masterclass gives practical examples from method validation and method transfer.

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

Today, process validation comprises three main steps:

Understand how to qualify scale-down models

The risk benefit ratio should be maintained at all times

Ensure the adequate flow of any arising safety concerns!

Viral Clearance online masterclass will give an overview of the sources and impacts of viral contaminations of biotherapeutics.

Sources and impacts of viral contaminations of biotherapeutics.

Overview on GMP-, as well as CTD requirements related to small molecule APIs

API synthesis development

Mastering Dissolution Testing: From Basics to Advanced Techniques

Mastering Dissolution Testing: From Basics to Advanced Techniques

Rich with practical insights and real-world applications