Clinical Development 401: Phase IV
*This microcourse includes optional CPE Credits and is powered by Biotech Primer, a trusted leader in life science training that simplifies complex topics for non-scientists.
Biotech Primer’s NASBA Profile
Optional CPE Credit: 1.0
Overview:
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.
- Section 1: Post Approval Clinical Trials: Explains the purpose of Phase IV studies and takes an in-depth look at numerous study examples including long-term safety and pharmacoeconomic studies.
- Section 2: Pharmacovigilance and Post-Marketing Safety Follow-Up: Explains important regulatory terms such as pharmacovigilance, safety signal, signal detection and signal analysis. The purpose of regulatory safety information reporting programs such as MedWatch in the US and EudraVigilance in Europe is thoroughly reviewed. The section ends by describing the post-marketing regulatory actions that may be taken in response to emerging knowledge of safety risks.
- Section 3: Real-World Evidence: Discusses how regulatory authorities, such as FDA, are increasingly using real-world evidence to improve regulatory decisions. Important sources of real-world data are identified.
By the end of the course, participants will be able to:
- 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
LEARN MORE
Use the promo code BIONTX15 at checkout to receive 15% off
