Preclinical Development

Master Preclinical Drug Development: From GLP-Compliant Studies to IND-Ready Data

More than 90% of drug candidates that enter preclinical testing never reach an IND filing. This certified online learning path in preclinical development, developed under the expert guidance of Dr. Patricia Kay, gives scientists, lab managers, and regulatory professionals the GLP framework, risk management tools, and nonclinical safety methodology needed to design studies that survive FDA and EMA scrutiny and deliver the evidence an IND demands.

Course Breakdown:

• Introduction to Good Laboratory Practice (GLP): Understand the regulatory foundation of nonclinical studies and how GLP principles protect data integrity from study design to final report.
• 21 CFR Part 58: GLP for Nonclinical Laboratories: Master the US regulatory requirements for nonclinical studies, including study director responsibilities, SOPs, and pre-IND inspection readiness.
• Laboratory Management Systems, ISO/IEC 17025:2017: Apply international competence standards so your testing and calibration activities meet both accreditation and regulatory expectations.
• OSHA Lab Safety Certified Training: Build the safety culture and compliance knowledge required to operate a safe, compliant nonclinical laboratory.
• Quality Risk Management: Use ICH Q9-aligned tools to proactively identify, assess, and mitigate risks across preclinical development activities.
• First in Human Safety Assessment (FIHSA) Dossier: Learn how preclinical safety data is compiled and evaluated to justify the transition from animal studies to first-in-human trials.

Why Choose This Learning Path?

• Expert-Led Curriculum: Developed by Dr. Patricia Kay, a senior life sciences leader with 20+ years in clinical and preclinical development, regulatory strategy, and quality management across cardiovascular, immunology, and infectious disease programs.
• End-to-End Coverage: From GLP fundamentals to ICH Q9 risk management and FIHSA dossier preparation, every critical dimension of preclinical compliance in one path.
• Flexible Learning: Fully self-paced and online. Study on your schedule and revisit any module as FDA and ICH guidance evolves.
• Recognized Certification: Earn a CPD/CEU-accredited, 21 CFR Part 11-compliant certificate you can share on LinkedIn to demonstrate preclinical competency to employers, sponsors, and regulators.

What You’ll Be Able to Do

• Design and document GLP-compliant nonclinical studies that meet FDA 21 CFR Part 58 requirements.
• Prepare and defend a First-in-Human Safety Assessment dossier ahead of an IND submission.
• Implement ICH Q9 risk management across laboratory operations.
• Support your organization’s pre-IND and pre-approval inspection readiness.

Who Should Enroll?

Whether you are a research scientist, laboratory manager, study director, regulatory affairs professional, or quality assurance specialist, this preclinical development training was built for you. It is equally valuable for pharmaceutical and biotech teams onboarding staff into GLP-regulated environments or building internal preclinical capabilities ahead of a first IND filing.

Build the Preclinical Foundation Every Drug Program Needs

GxP Training delivers certified, employer-recognized training to life sciences professionals worldwide. In an era of increasing FDA scrutiny of nonclinical data packages, preclinical competency is no longer optional. It is the foundation of every successful development program. Enroll today and take the next step in your preclinical career.