Drug Development Overview Primer
CPE Credit: 2.0
Drug Development Overview Primer offers a broad overview of the journey small molecule and biologic drugs take from concept to market. Participants gain a high-level understanding of the entire drug development pathway, from preclinical research to clinical trials, regulatory processes, and the roles of patents and exclusivity. The course emphasizes the general distinctions between biologics and small molecules, touches on biosimilar and generics development, and introduces key challenges such as high costs, long timelines, and success rates. Reserve your spot now!
Section 1
Learn about the key differences between small molecule drugs and biologic drugs, and how these impact their development, regulation, and applications in modern medicine.
Section 2
Learn about the complex regulatory landscape of the pharmaceutical industry, including the roles of the FDA, product exclusivity, and the drug development life cycle.
Section 3
Learn about the complex process of drug development, from preclinical studies to clinical trials, regulatory approvals, and post-approval life cycle management.
Five Takeaways
- Examine the sequential stages
of preclinical and clinical development, including the distinct objectives of each
phase. - Discover the differences in production and regulatory pathways for small molecule drug and biologics.
- Gain insight into the FDA’s review process, including IND, NDA, and BLA filings, rolling reviews, and milestone meetings.
- Explore the significance of patents and data exclusivity in incentivizing innovation and protecting investments.
- Distinguish between the complexities of developing biosimilars versus generic drugs,including regulatory and cost challenges.
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
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