Live Drug Development Immersion
Gain a strategic understanding of the scientific, regulatory, and commercial decisions that drive a drug from discovery to launch. Drug Development Immersion explores the evaluation of drug candidates, the design of clinical trials, the acceleration of regulatory approvals, and the management of products 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 to better evaluate pipelines
- Understand the roles of regulatory agencies worldwide and list the tools they use to ensure approved drugs are safe and efficacious
Rapid learning for results-driven professionals
- Designed for non-scientists in the life science industry
- Taught by experts with real-world industry experience
- Focused on practical, applicable knowledge
- Ideal for individual learners or company teams
- Trusted by top biotech and pharmaceutical companies
Book a 15 minute call to bring this course onsite
- Overview
- Agenda
- Logistics
- FAQ
What You'll Learn
- 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 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. - 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. - 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.
Logistics
Customized Training, Delivered Your Way
Biotech Primer designs and delivers customized courses tailored to your organization’s specific needs. Whether live onsite at your location or live online, our expert-led programs range from half-day sessions to three-day deep dives—ensuring the right fit for your team’s schedule and goals.
Deliverables
- Expert-Led Course Content: Customized training developed and delivered by seasoned industry professionals.
- Comprehensive Course Materials: Electronic PDF of all presentation slides provided for reference and continued learning.
- Interactive Course Activities: All required lab materials, case studies, and supporting documents supplied to facilitate hands-on engagement.
- Certificates of Completion: Formal recognition for participants who complete the course.
FAQ
What options are there for live training?
Who are the instructors?
Are training materials provided?
Do I receive a certificate?
What can Biotech Primer’s in-house training offer my team?
How many people typically attend your customized in-house training sessions? What is the minimum number of participants? What is the maximum number of participants?
What sort of training materials do you provide?
Can you hold the training at our company facility?
What kind of room setup is needed?
Do you provide in-house training internationally?
I’m looking for training on a topic not listed on your website. Can you help?
Do you offer half-day training sessions?
How far in advance do I need to book in-house training?
How do I contact Biotech Primer for questions about customized training options for my team?
Do you offer services beyond training?
Our Executive 
Certifications
Cannot make our live class? Consider one of our Executive Certifications.
Drug Development Executive Certification
- CPE:13.50 Credits
- Time:10.5 Hours
- Total:12 Courses
Drug Manufacturing Executive Certification
- CPE:14.50 Credits
- Time:10 Hours
- Total:11 Courses
