Pharma

 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?

Microbiological contaminations can occur on many levels.

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

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.

Drafting the well structured, practical, clear and concise documents which achieve their objectives

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

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

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

What the FDA is and how the entity is organized

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

Guidance for conducting pesticide residue analysis, reviewing analytical results, or writing analytical reports

Focus on topics and rules with a significant practical impact on routine residue analysis

Learn more about identification and control of Leachables and Extractables

Key points for successful development and registration of your pharmaceutical products