This practical course helps you to explore a bridge between the troubled waters of legal compliance and the use of rapidly evolving untested technology in the healthcare industry.
This practical course provides an in-depth understanding regulatory landscape for national CTA
Gain an in-depth understanding of the pharmaceutical directives and
guidelines related to GDP for Medicinal Products within the Supply Chain.
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.
The pharmaceutical industry is aware that the International Council for Harmonisation is planning to merge the guidelines for Good Clinical Practice (E6) and General Considerations for Clinical Trials (E8).