Pharma

Paving the Way from Development to Lifecycle Management

The training aims to generate a common understanding of how to best interlink two areas and create highly efficient processes.

International experiences

The EU Medical Device Regulation (MDR)

This online masterclass will address regulatory requirements related to cell bank establishment and testing.

The Master Cell Bank is not only the starting point of GMPs but also the starting point of the therapeutical recombinant proteins and GTP

RBQM principles that align with regulatory expectations

RBQM principles that align with regulatory expectations

Aseptic Filling of Biologics & Finish

Aseptic Filling of Biologics & Finish

Key elements for a successful development of a drug product analytical development

Pharmacokinetics (PK) play a key role in drug development

Drug Interaction studies!

Optimizing drug development and translational medicine strategies

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

The latest revision to ICH GCP

Design stability studies for global marketing

Increase the likelihood of studies receiving regulatory approval

Global Medical Device regulations

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

Away from the traditional One-Size-Fits-All approach

Precision Medicine approach

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

Managing CMOs with condence, insight and understanding

The Entry Level CMC Masterclass covers the general requirements for small molecules and biologics.

Key points for successful development and registration of products in US

Key points for successful development and registration of your pharmaceutical products