During these unprecedented times, it's important to keep your drug development program moving toward approval.
This session will highlight strategic actions to take right now to ensure that you minimize delays including:
1. What to do in the interim if your study is on pause
2. Considerations for planning and start-up of new studies
3. What can you be doing now to minimize delays as backlogged studies initiate
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.
Course Objectives
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.