Pharma

A series of practical exercises will take place throughout the programme

This Masterclass will train you in CRO oversight, and teach you how to design and implement the systems your company needs.

Critical biological information to enable understanding of the cell and gene therapy tools and therapies both existing today and coming in the near future.

This is a central topic that is important for both successful marketing authorisation and GMP compliance

The attendee will also gain practical experience by applying the tools and skills learned to challenging scenarios.

The MasterClass will provide an updated overview on GMP-, as well as CTD requirements related to small molecule APIs

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

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

This course is providing practical insights in the challenges of Technology Transfer and on how implementation of Quality by Design principles.

This comprehensive and detailed online masterclass describes the PK/PD studies from an industrial perspective to achieve a successful regulatory submission.

This masterclass will provide a comprehensive overview on any of the topics relevant in this context

Paving the Way from Development to Lifecycle Management

Meeting the FDA US requirements

The training will provide practical advice on benefit risk framework and assessment

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

This online course builds upon the fundamentals of risk management in clinical trials

Unlock the keys to successful market access in the pharmaceutical industry

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

Clinical trial conduct in the United States must follow the FDA’s regulations as published in the CFR

Learn more about identification and control of Leachables and Extractables

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

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

The focus of this two half day training will be on providing an update of ongoing activities regarding medicines’ signal management.

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

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

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

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

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

This course give you an overall and complete overview about the requirements of the European Medical Device Regulation.

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

The training will provide practical advice on benefit risk framework and assessment