Navigate the regulatory mechanics of drug development — from IND submission through NDA/BLA approval and post-marketing obligations. Learn how regulatory agencies think, what they expect, and how to build regulatory strategy as a competitive advantage. Course 3 of the Clinical Development Strategy track.
Studied within the Clinical Development Strategy track, which admits by invitation. The credential is included.
Modules
7
Lessons
22
Knowledge checks
7
Study time
~about 11h
Final exam65 questions · 80% to pass · 90 minutes · up to 3 attemptsICH E6(R3)Advanced
What you will be able to do
01Analyze the organizational structure, review processes, and decision-making culture of major regulatory authorities (FDA, EMA, PMDA, NMPA, Health Canada) and evaluate how these differences shape global development strategy
02Evaluate expedited regulatory pathway options—including Breakthrough Therapy, Accelerated Approval, Fast Track, Priority Review, PRIME, and conditional marketing authorization—to design an optimal regulatory pathway strategy for a given development program
03Design comprehensive regulatory meeting strategies for FDA Type A/B/C meetings and EMA scientific advice, including briefing document construction, question framing, and position management
04Apply the principles of regulatory negotiation to manage agency disagreements, respond to clinical holds, navigate dispute resolution mechanisms, and build productive long-term relationships with regulatory authorities
05Construct and manage the IND lifecycle—from initial submission through protocol amendments, information amendments, IND safety reporting, and annual reports—in compliance with 21 CFR 312 requirements
06Design an NDA/BLA or MAA submission strategy that integrates clinical data package construction (ISS/ISE, ICH E3 clinical study reports), submission timing, rolling submission tactics, and pre-submission meeting objectives
Show all 10 outcomes
07Evaluate labeling strategy as a regulatory and commercial instrument, including USPI/SmPC development, label negotiation tactics, and advisory committee preparation
08Synthesize post-marketing regulatory obligations—including PMRs/PMCs, REMS, RMPs, PSUR/PBRER, and confirmatory trial requirements—into an integrated post-approval regulatory plan
Seven modules,one final exam.
Seven modules and twenty-two lessons, each module closing with a knowledge check, and a final exam to complete the course.
A knowledge check closes every module
Pass the final exam at 80% to complete the course
IThe Global Regulatory Landscape3 lessons · knowledge check
1.1Regulatory science and the regulatory state
1.2Major regulatory authorities
1.3
Studied as part ofthe Clinical Development Strategy track.
Regulatory Strategy & Agency Interactions is the third of three courses in the Clinical Development Strategy track. The track admits by invitation, and an invitation opens all three courses.
Clinical Development Strategy
Courses
3
Lessons
74
Score 80% or higher on every final exam and your credential is issued, with the printable certificate included.
Not separately. Regulatory Strategy & Agency Interactions is part of the Clinical Development Strategy track, which admits by invitation; an invitation opens all three courses.
What does the final exam ask?
Sixty-five questions in 90 minutes, with 80% needed to pass, and up to three attempts. Each module also closes with a knowledge check.
Is it aligned to ICH E6(R3)?
Yes. The course works from ICH E6(R3).
Does course access expire?
No. Access is yours for good.
Study Regulatory Strategy & Agency Interactions,within the Clinical Development Strategy track.
An invitation to the Clinical Development Strategy track opens all three courses and every final exam. Course access does not expire.
09Design a regulatory strategy document that aligns with the clinical development plan and commercial objectives, incorporating competitive intelligence, regulatory pathway selection, and risk mitigation
10Evaluate the role of ICH harmonization, CTD/eCTD format standardization, and regional regulatory convergence in enabling efficient global development programs
Course III · This courseRegulatory Strategy & Agency Interactions
Issued when you passYour Clinical Development Strategy credential
A public verification record you can share as a link, and the printable certificate. Both included.
Can I take this course on its own?
Not separately. Regulatory Strategy & Agency Interactions is part of the Clinical Development Strategy track, which admits by invitation; an invitation opens all three courses.
