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!
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.
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Five 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
Features
- Closed Captioning in English, Spanish, French, French Canadian, Hindi, Japanese, Korean, Mandarin, Russian, Standard Arabic
- Transcripts in English, Spanish, French, French Canadian, Hindi, Japanese, Korean, Mandarin, Russian, Standard Arabic
- Course materials
- Real-time tracking
- Progress reporting
- Accessibility features
- Corporate account upgrades
- LinkedIn certificate attachment
- Verified certificates
FAQ
- How long do I have to complete an on-demand course? You have one year from the date of purchase to complete the course. During that year, you may watch the class an unlimited number of times.
- What happens if I don’t complete the course in one year? There are no time extensions. If you want to complete the course, you must purchase it again.
- How long are the on-demand classes? Our longest course has a running time of 90 minutes. However, most have a running time of 45 minutes. The running time is listed for each class on its registration page. The assessment at the end of each course takes between 10-20 minutes to complete.
- Are there any downloadable class materials? No. All course slides and transcripts remain on your Biotech Primer dashboard, but they are always available for review.
- What is the format of the on-demand classes? The online class begins with the class objectives and the course itself and ends with a summary of what you learned. The course is a series of images and text accompanied by a professional voice-over and subtitles. Subtitles are available in 9 languages. The course ends with a quiz to assess your understanding.
- Can I repeat the course? You can repeat the course as often as you like within your one-year access.
- How many times can I take the course quiz? You have three chances to pass the quiz. A passing score is 75% or higher. You must pass the quiz to receive the class certificate. Your quiz score will be shown on your class certificate.
- May I share a course I purchased with others? Each course is to be taken by one individual. If you want to learn as a group, please contact us at training@biotechprimer.com for group pricing.
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