Events

This Masterclass will go through the key scientific points for the development and registration of your medicine, and provide a focus on US FDA and Europe expectations for CMC, and also this training covers general requirements for small molecules and...

This masterclass will give you a clear structured overview and introduction, how to apply MDSAPRequirements in your internal audit program and how to conduct internal audits with MDSAP requirements regarding audit structure, audit checklist and non conformity rating.  

Delegates will explore the impact on the macro economy and financial risk factors and simulate potential changes in EVE, Capital, LCR and NSFR on a simple bank balance sheet.  

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.   

This Masterclass will train you in CRO oversight, and teach you how to design and implement the systems your company needs in order to issue a good RFP (Request For Proposal).  

This 3-day online course will detail the fundamental biological components for gene therapy and gene-modified cell therapies and outline important consideration for selecting the most appropriate vectors and specific safety aspects.  

Professional stability testing is based on a profound knowledge of all regulatory and scientific necessities, which are the content of this masterclass. As stability testing is GMP-relevant respective processes and QA measures are often questioned during inspections.  

This comprehensive and interactive online course provides the theory of root cause analysis and CAPA management within the context of clinical research.

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

This online training will also address potential issues encountered when establishing cell banks and will discuss operational aspects for ensuring good quality cell banks.