The training aims to create deeper understanding why biotechnological products – and as a consequence biosimilars – are a unique product category and what aspects have to be considered in R&D and Drug Regulatory Affairs.
This course will cover the definition of combination products, EU regulatory pathways, and will explain the current state of developments as medical device manufacturers and marketing authorisation holders prepare for the new requirements.
Join our training 3D Printing Solid Dosage Forms Medical Devices to explore different characterization techniques foranalysing 3D printed structures and what eachtechnique reveals about your sample.
The course will provide relevant insights into bioprocesses using cells in bioreactors.
This course will give participants a solid foundation on product labelling in the life sciences industry by providing a good understanding of the key concepts, an opportunity for sharing knowledge and best practices and provide a forum for discussion amongst peer functions and teams.
A scientific & technical expedition through the world of vaccines and their dedicated therapies for human use.
This training course provides an overview of how to develop an optimized freeze-drying process, from freezing, primary and secondary drying to what is required to successfully move the cycle to scale-up for production.
This practical course provides an in-depth understanding of signal detection, signal validation & assessment as well as signal communication.
This two-day course with workshop and case examples is designed for Managers and Sponsors of GLP and/or GCP Studies to develop a working knowledge of GLP and GCP requirements to support the implementation of the Quality Management System in a GLP and/or GCP setting.
In this course you will gain insight into the diversity of aggregates and particulates present in biopharmaceuticals revealed by new orthogonal methods.