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The PTI Knowledge Hub

Interviews

60 seconds jean michael cardot

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.

Read the interview.

Webinars

biologics

Learn about the impact of process changes for recombinant therapeutics and when comparability studies are required. Watch the webinar.

risk management

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.

cmc

Learn about why developing biotech products is so challenging, about worldwide regulations regarding CMC studies, and about key success factors. Watch the webinar.

vendors

Explore the latest changes to sponsor responsibility included with developments to ICH E6 Revision 2. Watch the webinar.

assay

Find out about factors critical to assay development and explore key differences between immunoassays and bioassays. Watch the webinar.

small molecule

Learn about regulatory guidance for small drug products (ICH, FDA, EMA) and about tests appropriate to different dosage forms. Watch the webinar.

assay2

This high level webinar will be provide you with valuable insights into the analysis validation of biological assays. Watch the webinar.

quality

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.

genotoxic

Find out more about the EMEA Guideline on the limits of genotoxic impuritires. Watch the webinar.

ivivc

Explore how to optimise IVIVC using your dissolution data. Watch the webinar.

risk based monitoring

Gain practical advice for designing protocol writing rules in this short but informative webinar. Watch the webinar.

cmc biotechnology

Examine the major analytical and stability differences between small molecule and biotech products and explore the CMC timelines for biopharmaceuticals. Watch the webinar.