Join our CMC Analytical Comparability online live training led by experts to understand principles of protein structure and comparative analytics.
The Quality & Regulatory Requirements for Biosimilars in the EU online live training aims to create a deeper understanding of 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.
Join our 3D Printing of Solid Dosage Forms & Medical Devices
training to learn about recent developments in printable solid dosage forms and medical devices.
This practical Signal Management in Pharmacovigilance online training provides an in-depth understanding of signal detection, signal validation & assessment as well as signal communication.
This course will provide a comprehensive, yet practical introductory guide to pharmacovigilance audits and inspections best practice to help navigate what is required to demonstrate compliance.
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.
This Clinical Project Management to Advanced your Clinical Programs online live course will focus on honing the skills for excellent Clinical Project Management.
his practical course provides an in-depth understanding of data integrity in a GMP context and brings clarifications on regulatory requirements as well as the examples of common data integrity issues reported by FDA and EU inspections.
Join Advanced IVIVC Professional
online live training to understand the selection of most appropriate data to establish IVIVC.
This interactive course is recommended for those who have experience in clinical trials & patient engagement and wish to develop their skills on how PRO measurement is best implemented to advance patient care.