Preclinical Development

Master Preclinical Drug Development: From Laboratory Science to IND-Ready Data

Before a compound ever reaches a human subject, it must survive rigorous preclinical evaluation — scientifically sound, fully GLP-compliant, and built to withstand regulatory scrutiny. This certified learning path, developed under the expert guidance of Dr. Patricia Kay, gives you the end-to-end framework to design, execute, and document preclinical studies that meet FDA and EMA expectations.

Course Breakdown:

• Introduction to Good Laboratory Practice (GLP): Establish the regulatory foundation of nonclinical studies — understand GLP principles and how they protect data integrity from study design to final report.
• 21 CFR Part 58: GLP for Nonclinical Laboratories: Master the US regulatory requirements governing nonclinical laboratory studies, including study director responsibilities, SOPs, and inspection readiness.
• Laboratory Management Systems – ISO/IEC 17025:2017: Apply international laboratory competence standards to ensure 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 environment.
• Quality Risk Management: Learn ICH Q9-aligned risk management tools and methodologies to proactively identify and mitigate risks across preclinical development activities.
• First in Human Safety Assessment (FIHSA) Dossier: Understand how preclinical safety data is compiled and evaluated to support the critical decision to proceed 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 professional with over 20 years of experience in clinical and preclinical development, regulatory strategy, and quality management.
• Comprehensive Coverage: From foundational GLP through risk management and FIHSA preparation, this path covers every critical dimension of preclinical compliance.
• Flexible Learning: Fully self-paced and online — study on your schedule and revisit content as regulations evolve.
• Certification: Earn a recognised certificate upon completion, demonstrating your preclinical competency to employers, sponsors, and regulators.

Who Should Enroll?

Whether you are a research scientist, laboratory manager, regulatory affairs professional, or quality assurance specialist entering or advancing in the preclinical space, this learning path was designed for you. It is equally valuable for pharmaceutical and biotech teams onboarding staff into GLP-regulated environments.

Build the Preclinical Foundation Every Drug Development Career Needs

Join thousands of life sciences professionals who have used GxP Training to earn recognised, employer-valued certifications. In an era of increasing FDA and EMA scrutiny of nonclinical data packages, preclinical competency is your foundation for a successful development career. Enroll today.