Deep Dive Drug Development Immersion

Q: Whom should I contact if I have a question about an on-demand course or a program?

Email us at training@biotechprimer.com and request a call.

Q: What are my options for purchasing on-demand courses?

Individual Courses Microcourses are individual 60-minute on-demand classes designed to provide focused instruction on a single, specific topic. Ideal for learners seeking quick, targeted knowledge. Comprehensive Programs Deep Dive Course Bundles are comprehensive, on-demand learning programs that last up to 9 hours. These course bundles cover a range of related topics and are designed to build a broader understanding of a subject area. Executive Certifications Programs are a curated series of on-demand Microcourses totaling up to 12 hours of learning. These certification programs encompass multiple interconnected topics and are ideal for professionals seeking to demonstrate advanced knowledge in a specific science subject area. Subscriptions On-Demand Courses Subscription can be purchased monthly or yearly. This provides users with unlimited access to over 100 hours of Microcourse content and Deep Dive programming. Executive Certification Subscription can be purchased on a yearly basis only. This provides users with unlimited access to all 100 hours of Microcourse content, Deep Dive programming, and four Executive Certifications. The four Executive Certifications are Biotechnology Executive Certification, Drug Development Executive Certification, Drug Manufacturing Executive Certification, and Medical Device Executive Certification.

Q: Who takes Biotech Primer courses?

Our learners come from a wide range of backgrounds, including C-level executives, consultants, regulatory professionals, sales teams, and even shift operators in drug manufacturing. Whether you’re new to life sciences or a seasoned professional entering a new role, our on-demand courses are designed to meet you where you are and help you grow your knowledge.

Q: What is the format of an on-demand course?

Each on-demand course starts with clear learning objectives and ends with a summary of key takeaways. Throughout the courses, you will have knowledge checks to assess your understanding of the material. To complete the course, you’ll take a short quiz that must be passed with a score of 75% or higher to receive your validated certificate. Closed captioning and transcripts are available in ten languages.

Q: How long are the on-demand courses and programs?

Most Microcourses run approximately 60 minutes, with a few extending up to 90 minutes. The Deep Dive programs are 5 to 9 hours in length. The duration is listed on each course page.

Q: How long do I have to complete a course?

If you purchase an individual Microcourse, you’ll have one month to complete it. If you purchase an individual Deep Dive program, you’ll have three months to complete it. If you purchase a monthly or annual subscription, your access lasts for the duration of your subscription. During your access period, you can revisit the course content as often as you’d like—there’s no limit on how many times you can view the material.

Q: Can I repeat a course or program?

Yes! You can rewatch as many times as you’d like during your access period.

Q: What happens if I don’t finish the course or program in time?

There are no time extensions, so to complete the course or program, you must repurchase it.

Q: How many times can I retake the course quiz?

You’ll have up to three attempts to pass the quiz. A passing score is 75% or higher, and your score will appear on your validated certificate.

Q: Will I receive a certificate after completing the Microcourse or Deep Dive program?

Yes! Once you’ve successfully completed your Microcourse or Deep Dive program, you’ll receive a validated digital certificate. You can upload it to your LinkedIn Licenses & Certifications section directly from your Biotech Primer dashboard to showcase your expertise.

Level: Beginner
CPE: 11.5 Credits
Time: 9 Hours
Price: $895.00 for 1 year

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

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CPE credits + certificate included
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$229 Per month

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$229 $199 Per month billed annually

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1-year access to all course material
CPE credits included
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Self-paced and on-demand
Ideal for focused, one-off learning

Deep Dive Drug Development Immersion

$895

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Overview

Agenda

Features
Justify This Training
FAQ

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Agenda

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.
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.
The Players: Who is Involved
Highlights the roles of subjects, sponsors, investigators, CROs, advocacy groups, ethics committees, and data monitoring committees.
General Principles: Ethics and Risk
Discusses risk management, data integrity, and minimizing bias through blinding, randomization, and ethical trial conduct.
The Regulatory Process
Highlights FDA and EMA regulatory frameworks, expedited programs, and approval pathways for small molecule drugs, biologics, generics, biosimilars, and orphan drugs.
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.
Conduct of Clinical Trials
Explains the purpose and elements of clinical trials, including study designs, endpoint selection, eligibility criteria, and safety reporting.
Clinical Development Phase I
Examines the purpose and structure of Phase 0 and Phase I trials, covering dose selection methods and bioequivalence studies.
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.
Clinical Development Phase III
Identifies the purpose and structure of Phase II trials, covering trial designs, database locks, and regulatory submissions.
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.

View Justification Letter