Pharma

A comprehensive overlook on benefit risk assessment in PSUR and RMP

Connection between risk management with PBRERs and benefit-risk assessment and tools

Managing CMOs with condence, insight and understanding

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

Biologics, Biopharmaceuticals, Biosimilars & ATMPs

A phenomena for complex therapeutics

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

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

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

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

Mastering Dissolution Testing: From Basics to Advanced Techniques

Mastering Dissolution Testing: From Basics to Advanced Techniques

Key points for successful development and registration of products in US

Key points for successful development and registration of your pharmaceutical products