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In this 60 second interview with Professor Jean-Michael Cardot, we take a look at the importance of IVIVC and the challenges professionals face when using IVIVC. Professor Cardot, the trainer for PTI’s upcoming course Pratical Solutions for In-Vitro In-Vivo Correlation, will advise on how IVIVC will impact and reduce the risk of your in-vivo studies.
Learn about the impact of process changes for recombinant therapeutics and when comparability studies are required. Watch the webinar.
Managing risk is essential in good oversight of a clinical trial, learn some of the key principles for risk management and mitigation. Watch the webinar.
Learn about why developing biotech products is so challenging, about worldwide regulations regarding CMC studies, and about key success factors. Watch the webinar.
Explore the latest changes to sponsor responsibility included with developments to ICH E6 Revision 2. Watch the webinar.
Find out about factors critical to assay development and explore key differences between immunoassays and bioassays. Watch the webinar.
Learn about regulatory guidance for small drug products (ICH, FDA, EMA) and about tests appropriate to different dosage forms. Watch the webinar.
This high level webinar will be provide you with valuable insights into the analysis validation of biological assays. Watch the webinar.
In this concise webinar Peter outlines the the four essential areas to enable you to effectively manage quality during a clinical trial. Watch the webinar.
Find out more about the EMEA Guideline on the limits of genotoxic impuritires. Watch the webinar.
Explore how to optimise IVIVC using your dissolution data. Watch the webinar.
Gain practical advice for designing protocol writing rules in this short but informative webinar. Watch the webinar.
Examine the major analytical and stability differences between small molecule and biotech products and explore the CMC timelines for biopharmaceuticals. Watch the webinar.