Pharma

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

This MasterClass is completed by fundamentals of an appropriate Quality Culture which constitute the basis for a successful PQS - besides all regulations.

The aim of a Risk Management plans and its Implementation Masterclass is to document the risk management system considered necessary to identify, characterise and minimise a medicinal product’s important risks. 

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.

QP`s role in clinical project setup will highlight the key points for quality and the qualified person (QP) to consider when setting up clinical trial

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

This MasterClass will provide best understanding on how process validation for biotechnological processes, which is the collection and evaluation of data from the process design stage through commercial production.

This online practical course provides an in-depth understanding of GCP requirements and their practical implications.

This informative training with two RP’s / RPI’s for all things GDP.

This topic is covered by the ICH M7 guideline which a harmonised practical framework.

This is a very interactive online course with a lot of workshops, putting the theoretical concepts into practice.

This MasterClass will provide best understanding on how process validation for biotechnological products, which is the collection & evaluation of data from the process design stage.

Interactive course providing excellent knowledge of the requirements laid down in ICH Q7

The training aims to generate a common understanding of how to best interlink two areas and create highly efficient processes.

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

This online masterclass will go through the key scientific points for the development and registration of your medicine.

Interaction between pharmaceutical companies and patients/users through the Internet. Social media and two-way communication.

NIS is helpful to obtain information forming hypotheses for new research projects.

The `Clinical(IMP) QP oversight` course will highlight the critical control points for the Qualified Person when handling Investigational Medicinal Product projects.

A number of aspects in the paper are also relevant for sustained and extended release dosage forms.

 This training will present Technical and regulatory requirements for developing a medicinal product which are becoming stricter every day, the products themselves become more and more complex.

This Online Masterclass will delineate potential adaptations to the traditional approach to productdevelopment, product characterization, manufacturing and timepoint for full completion of certain quality data packages.

Viral Clearance online masterclass will give an overview of the sources and impacts of viral contaminations of biotherapeutics.

This 1 day online masterclass gives practical examples from method validation and method transfer.

A series of practical exercises will take place throughout the programme to give participants the opportunity to apply their knowledge under the guidance of our experienced trainers.

Interaction between pharmaceutical companies and patients/users through the Internet. Social media and two-way communication.

Interactive course providing excellent knowledge of the requirements laid down in ICH Q7

This MasterClass will provide best understanding on how process validation for biotechnological processes, which is the collection and evaluation of data from the process design stage through commercial production.

Participants in this online masterclass will learn which trials in minors make sense, and which ones are pointless and even harmful.

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