CMC & Product Quality
Innovation in CMC (Chemistry, Manufacturing and Controls) is at the heart of the pharmaceutical industry. At the same time, the supply of medicines is increasingly impacted by concerns related to environment, climate and sustainability. In combination, these may represent an opportunity for a further Green revolution in the manufacturing and supply of medicinal products. This track will provide insights into how manufacturers and regulators can collaborate to deliver this revolution without risks to the supply of medicines.
Who is This Track Designed For?
This track is recommended for regulatory affairs, manufacturing, quality assurance, and other professionals who want to keep up to date with most recent developments in science, technology and regulations impacting CMC/GMP related activities.
Senior Director, CMC Excellence, Global Regulatory Affairs
GlaxoSmithKline, United Kingdom
Head Regulatory Affairs CMC
Bayer US LLC, United States
DIA Europe 2023 Highlights
It will provide updates on key developments on the GCP Renovation (ICH E6, ICH E8), Clinical Trial Regulation, the Clinical Trial Information System, data submission, transparency, navigating ethical approval, study design in the digital age, innovative clinical trial designs (umbrella and platform trials, patient centricity), digital tools in development and other hot topics. It should be a must-attend for optimising development programmes and identifying cost savings through efficiency and innovation.