Pharma

What the FDA is and how the entity is organized

Learn how to define, evaluate, and respond to risks, and also how to define critical data.

Learn how to define, evaluate, and respond to risks, and also how to define critical data.

Interventional studies fall into the scope of Directive 2001/20/EC and will no be the object of this Masterclass.

Learn more about identification and control of Leachables and Extractables

Clinical trials are the cornerstone for advancing medical knowledge by evaluating the efficacy and safety of health-related interventions

Principles, advantages and potential challenges of the adaptive design methodology

Today, process validation comprises three main steps:

Statistical impact on drug supply as well as how to properly set-up your IRT system

Statistical impact on drug supply as well as how to properly set-up your IRT system

Key points for successful development and registration of your pharmaceutical products

Quality requirements of pharma and healthcare packaging

Quality requirements of pharma and healthcare packaging

Microbiological contaminations can occur on many levels.

Pharmacopoeias play a major role in quality standards for the manufacture and control of medicines in Europe and worldwide

Mastering Drug-Device Combination Products

Components of successful project management such as interaction between project activities and key decisions will be highlighted

An advanced-level masterclass for participants with a minimum of 5-10 years of industry experience

Impurities in active ingredients, excipients, medicinal products and packaging materials

Master Cell Bank is not only the starting point of GMPs but also the starting point of the manufacturing process of therapeutical recombinant

What is meant by “Contamination Control Strategy”? A complex system of measures designed to minimize the risk!

 What is meant by “Contamination Control Strategy”?

Mastering Dissolution Testing: From Basics to Advanced Techniques

Gain invaluable insights into the development, regulation, and deployment of AI-powered medical devices

Managing CMOs with condence, insight and understanding

Pharmaceutical companies and patients/users interact through theInternet,Social media,and two-way communication.

Understand how to qualify scale-down models

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

A practical guide

A practical guide

Microbiological contaminations can occur on many levels.

From regulatory compliance to technical innovation, from financial scrutiny to operational efficiency

Current developments for impurities in small molecule APIs and respective medicinal products

QbD concept, process validation, and regulatory requirements!

How to design and implement the systems your company needs.

The latest revision to ICH GCP

Implementation of Quality by Design principles.

Implementation of Quality by Design principles.

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

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

Key points for successful development and registration of products in US

Development and validation of bioassays

Development and validation of bioassays

Beyond Child's Play

Beyond Child's Play