Pharma

This masterclass helps business leaders understand how to take action to manage nature related risks

Unlock the keys to successful market access in the pharmaceutical industry

The latest revision to ICH GCP

Adoption of New Critical to Quality Requirements

Learn more about identification and control of Leachables and Extractables

Understand how to qualify scale-down models

Pharmacokinetics (PK) play a key role in drug development

Increase the likelihood of studies receiving regulatory approval

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

Scope of the ICH Guidelines Q6B for biotechnological products

The use of PK during drug development will also be described.

Ensure the adequate flow of any arising safety concerns!

The risk benefit ratio should be maintained at all times

 The course covers general requirements for small molecules and biologics

 Manufacturing pharmaceuticals, especially biological products, is complex and expensive

Unlock the keys to successful market access in the pharmaceutical industry

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

How to design and implement the systems your company needs.

Principles, advantages and potential challenges of the adaptive design methodology

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

Are you planning to enter the EU or UK market to expand your market in the region?

This 2 days online masterclass gives practical examples from method validation and method transfer & pitfalls.

This intensive online training will be held over 4 consecutive half-day sessions for lawyers, and paralegals, working in the pharmaceutical industry.

 The MasterClass will cover aspects that are relevant for non-toxicologists involved in drug development