BIO Professional Development
Through a curated network of education alliance partners, BIO offers industry professionals executive training and development resources for accelerating career growth
Clinical Development 401: Phase IV
Clinical Development 401: Phase IV uncovers what happens after a new drug gains approval and enters the marketplace. This class, the 4th and final in the comprehensive Biotech Primer Clinical Development series, exposes the crucial role of regulatory agencies in protecting public health by monitoring all drugs' pharmacovigilance in real-world conditions. The FDA's safety information and adverse events reporting program called MedWatch is highlighted. Don't miss out on this opportunity to be informed on post-approval drug considerations. Complete your understanding of the clinical trial process by signing up for Clinical Development 401: Phase IV today
Takeaways
- Highlight the significance of Phase IV clinical trials in monitoring a drug's real-world performance and safety.
- Identify the limitations associated with Phase I-III clinical trials in representing the broader patient population and detecting rare side effects.
- Appreciate the importance of pharmacovigilance in post-marketing drug safety follow-up.
- Illustrate the role of regulatory actions in mitigating risks associated with approved drugs and safeguarding public health.
- Identify two government-run reporting programs used to report adverse reactions to approved medicines.
Certificate Requirements
Complete the course quiz with a passing score of 75% or higher
Gain foundational knowledge on clinical development: trial conduct, design principles, GCPs, & trial phases I-IV.
Explore Phase I objectives & regulatory roles. Learn about bioequivalence, PK/PD studies & dosing protocols."
Discover Phase II/III objectives & trial design nuances. Learn about endpoints, statistics, & expedited approvals
Explore drug approval process for small molecules & biologics: regulatory bodies, application process, preclinical to clinical studies, final approval.
A digital strategy can no longer lie within a siloed digital or innovation team. It’s critical to integrate digital across the enterprise to maintain a competitive edge.
Do you need to understand the drug development process, including details about a drug's life cycle from its discovery through post-marketing studies? This is the course for you.
Explore biologics discovery: target screening, validation, optimization & transition to preclinical development.