The COVID-19 pandemic has not only disrupted our lives on all fronts, but it has also exposed our need to focus on the highest quality and safety in testing. With insufficient testing and false-negative results, COVID-19 testing has shown how devastating insufficient testing can be for our community on a global scale. However, experiencing oversight of the importance of safety testing is not a new occurrence. Bioanalysis, due to its critical nature in drug development has seen its fair share of devastating testing failures.
Taking the lessons learned from this current health crisis, let's come together to understand the following:
• Why this happened
• Areas of risk in our own industry
• How we can apply these lessons to our own systems and processes to avoid similar failures
AAPS members, students, and academicians enjoy special pricing. Previews of each of the lectures are available. Participants have access to the course content for a 6 month period following purchase.
Introduce the statute, regulation and guidance relationships.
Review positioning the quality pillars (GLP, cGMP, and GCP) in eCTD submissions.
Compare and contrast critical GLP roles and responsibilities from the perspectives of the Sponsor, Study Director, Principal Investigator and Quality Assurance.
Provide a detailed understanding of the relevant GLP formulation nuances.
Review ICH Q10 in-depth.
Gain insight into the value of linking development knowledge to manufacturing, and knowledge management to continuous improvement.
Differentiate how to perform appropriate quality investigations during development and commercial batch manufacturing, and when managing investigations of external vendors such as suppliers and CROs.
Discuss pertinent models for conducting clinical research, focusing on new drug development and approval.
Understand how to put GCP into action from obtaining Informed Consent, to composing a Protocol, to selecting Clinical Sites and ending with describing the Data Review Committee.