Deep Dive Drug Development Immersion – CPE LATEST

- Level: Beginner
- CPE: 11.5 Credits
- Time: 9 Hours
Drug Development Immersion provides a strategic overview of how scientific, regulatory, and commercial decisions drive a drug from discovery to launch. Learn how candidates are evaluated, trials are designed, approvals are accelerated, and products are managed for long-term success.
- Become proficient in the terminology and acronyms used in preclinical and clinical development
- Learn the essential activities and regulatory requirements involved in Phase I through Phase IV clinical trials
- Understand the roles of regulatory agencies worldwide and list the tools they use to ensure approved drugs are safe and efficacious
- Best Value: Unlimited Learning
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- Up to 12-month unlimited access
- Content designed for all skill levels: Beginner to Advanced
- CPE credits included with every course
- Learn at your own pace
- Choose the subscription plan that fits your goals
Get full access to this course with a one time purchase.
- 1-month access to all course material
- CPE credits included
- No subscription required
- Self-paced and on-demand
- Ideal for focused, one-off learning
- Overview
- Agenda
- Features
- Justify This Training
- FAQ
Watch Trailer
Agenda
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Setting the Stage
Compares the characteristics of small molecule drugs to biologics and provides insight into the success rates, timelines, and costs each incurs during drug development.
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The Business of Drug Development
Explains how pharmaceutical companies use the Target Product Profile (TPP) and stage gate criteria to guide go/no-go investment decisions.
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The Players: Who is Involved
Highlights the roles of subjects, sponsors, investigators, CROs, advocacy groups, ethics committees, and data monitoring committees.
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General Principles: Ethics and Risk
Discusses risk management, data integrity, and minimizing bias through blinding, randomization, and ethical trial conduct.
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The Regulatory Process
Highlights FDA and EMA regulatory frameworks, expedited programs, and approval pathways for small molecule drugs, biologics, generics, biosimilars, and orphan drugs.
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Preclinical Development
Teaches the objectives of each sequential step in evaluating candidate drugs before submitting an IND or CTA for authorization to begin human studies.
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Conduct of Clinical Trials
Explains the purpose and elements of clinical trials, including study designs, endpoint selection, eligibility criteria, and safety reporting.
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Clinical Development Phase I
Examines the purpose and structure of Phase 0 and Phase I trials, covering dose selection methods and bioequivalence studies.
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Clinical Development Phase II
Explores the purpose and structure of Phase II trials, covering randomized control trials and statistical considerations such as null hypothesis, P values, and Type 1 and 2 errors.
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Clinical Development Phase III
Identifies the purpose and structure of Phase II trials, covering trial designs, database locks, and regulatory submissions.
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Clinical Development Phase IV
Discusses the purpose of Phase IV trials, covering post-marketing safety reporting, pharmacovigilance, and lifecycle management.
Features
- Closed Captioning in English, Spanish, French, French Canadian, Hindi, Japanese, Korean, Mandarin, Russian, Standard Arabic
- Viewable course workbook
- Real-time tracking
- Progress reporting
- Accessibility features
- Corporate account upgrades
- LinkedIn certificate attachment
- Verified certificates
Justify This Training
View our “Justify This Training” checklist and letter to craft a persuasive request that clearly shows the value of Biotech Primer training to your role and your company. This step-by-step guide helps you highlight ROI, align with business goals, and increase your chances of getting this course approved.
FAQ
Our Executive
Certifications
Cannot make our live class? Consider one of our Executive Certifications.

Drug Development Executive Certification
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- CPE:13.50 Credits
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- Total:12 Courses

Biotechnology Executive Certification
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- CPE:14.50 Credits
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- Total:12 Courses

Drug Manufacturing Executive Certification
- Level:Beginner
- CPE:14.50 Credits
- Time:10 Hours
- Total:11 Courses

Medical Device Executive Certification
- Level:Beginner
- CPE:12.00 Credits
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- Total:9 Courses