Search Courses and Programs
Use this form to search course ID, name, description, outline, and objectives. This is a multiple word search. Each word must be 3 characters or more (e.g., GMP, GCP, Clinical, etc). Shorter words and any special characters will be ignored. You can search courses for things such as GMP001S1, GAMP, Pharmacovigilance, Quality Assurance, ALCOA, Validation, Clinical Trials, Cleaning Validation, or Drug Safety.
Searching courses for: Drug Safety
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Introduction to Drug Safety and PharmacovigilanceMaster the essentials of drug safety monitoring and risk management – skills vital for medicinal product developers, license holders, and clinical investigators. Beyond fulfilling your duty to protect … Course ID: AV02 |
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Clinical Trial Safety Reporting Requirements in the EU and USADeepen your expertise in safety reporting by learning the legal and regulatory frameworks governing clinical trials in the EU and USA. This advanced course builds on CT13 and delivers jurisdiction-spe … Course ID: CT14 |
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Drug Safety and Pharmacovigilance Professional Certification ProgramDrug Safety and Pharmacovigilance Professional Certification ProgramProtect public health. Advance your career. Become a certified expert in drug safety and pharmacovigilance.In today's highly regulat … Course ID: AV01 |
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Good Pharmacoepidemiology Practice Professional Certification ProgramGood Pharmacoepidemiology Practice (GPP) Professional Certification ProgramMaster the skills to generate and apply real-world drug safety evidence. This comprehensive certification program equips stud … Course ID: AV01B |
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Introduction to Pharmacokinetics and Pharmacodynamics in Drug Development and RegistrationGain a solid foundation in the science that connects drug development with patient outcomes. This course introduces you to PK/PD principles and their vital role in drug approval and clinical applicati … Course ID: PKPD01 |
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Safety Reporting in Clinical Trials (Adverse Event Reporting)Confidently navigate the complex regulatory landscape of adverse event reporting in clinical trials. This course breaks down responsibilities for investigators and sponsors, and clarifies key terminol … Course ID: CT13 |
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Drug Safety: Signal Detection and Management in PharmacovigilanceDiscover how to identify, validate, and manage safety signals that protect patients and preserve your product's benefit-risk profile. This course equips you with practical tools and methods – from med … Course ID: PV04 |
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GMP Awareness: Food ManufacturingStep into the world of current Good Manufacturing Practices (cGMP) for the food industry and gain the knowledge you need to ensure top-quality, safe food production. In the USA, cGMP for food manufact … Course ID: GMPF01 |
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Drug Safety: Urgent Safety RestrictionsLearn to respond decisively when safety signals demand urgent regulatory action. This course demystifies Urgent Safety Restrictions (USRs) in Europe, preparing you to act swiftly and effectively.Under … Course ID: PV06 |
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Pharmacokinetics and Pharmacodynamics for ProfessionalsPharmacokinetics and Pharmacodynamics for ProfessionalsMaster the science that powers modern drug development. This specialized program provides a comprehensive, practical understanding of Pharmacokin … Course ID: AV01A |
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Medical Device vs. Drug: Comparing and ContrastingClarify the regulatory and operational differences between medical device and drug clinical trials. This course breaks down definitions, approval pathways, safety reporting, and global perspectives, w … Course ID: CP010a |
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Drug Safety: Risk Management Planning for Medicinal ProductsElevate your pharmacovigilance practice by mastering proactive risk management planning. This course delivers a step-by-step guide to developing compliant, effective risk management plans for global m … Course ID: PV05 |
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Drug Safety: Good Pharmacoepidemiology PracticeBridge the gap between clinical pharmacology and epidemiology to deliver high-impact, real-world evidence. This course is designed for professionals conducting and analyzing pharmacoepidemiological re … Course ID: PV07 |
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Regulatory Affairs for Clinical Research (US & EU) Professional Certification ProgramRegulatory Affairs for Clinical Research (US & EU) Professional Certification ProgramAdvance your career in regulatory affairs with our 'Regulatory Affairs for Clinical Research (US & EU) Professional … Course ID: GCP00A2 |
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GxP: Good Practices (GxP) in Drug Development and ManufacturingTake your first step into the regulated world of life sciences with this entry-level GxP course. Understand how the pharmaceutical industry operates, the role of regulatory authorities, and the essent … Course ID: GXP01 |
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Regulatory Affairs: The Biologics License Application (BLA) for Marketing Approval in the USAMaster the process of obtaining FDA approval for biological products via the BLA. Learn about submission content, format, expedited review options, and regulatory requirements.Understand BLA structure … Course ID: SUB15 |
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Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (ICH E2A)Gain mastery over expedited safety reporting in clinical trials with this deep dive into the ICH E2A guideline. Understand key definitions, standards, and procedures that keep safety reporting accurat … Course ID: CP012a |
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OSHA: Compressed Gas SafetyGases for medical use are prescription drugs that must be carefully used, moved, and stored per regulations and guidelines from the Occupational Safety and Health Administration, the National Fire Pro … Course ID: OSHA-03 |
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Clinical Trials: The Investigational New Drug Application (IND) to Conduct FDA-regulated Clinical TrialsTake your investigational drug from the lab to the clinic by mastering the FDA's IND process. This course provides the tools you need to prepare and submit a complete, compliant application.Learn the … Course ID: GCP007 |
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Clinical Trials Management (US & EU) Professional Certification ProgramClinical Trials Management (US & EU) Professional Certification – Advance Students Career in Clinical Research, Regulatory Affairs, and Trial OversightStep into a leadership role in clinical research … Course ID: GCP00A1 |
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Clinical Trials: Preparing for an Audit or InspectionAudits and inspections don't have to be stressful – if you're prepared. This course equips you to meet US FDA and European regulatory expectations with confidence.Understand the scope and purpose of G … Course ID: GCP006 |
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Overview of ICH E8(R1): General Considerations for Clinical Studies GuidelineICH E8(R1) is the umbrella guideline connecting the entire ICH "E" family, including Good Clinical Practice (ICH E6). This revision modernizes how clinical trials are designed, planned, managed, condu … Course ID: CP019a |
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Investigator Initiated Clinical TrialsDiscover the unique responsibilities of investigator-initiated trials (IITs) and how they differ from sponsor-led studies. Learn what it means to be both the investigator and sponsor, and the regulati … Course ID: CP011a |
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Quality Management System Requirements for Medical Devices under ISO 13485:2016 and FDA QMSRManufacturers of medical devices need to provide assurance of the quality of their products. Central to this effort is the establishment and maintenance of a quality management system (QMS). The inter … Course ID: MD02 |
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GCP: ICH, Harmonization, and Principles of GCP ICH E6(R3)Step into the world of international clinical research with the confidence to meet-and exceed-global standards. This dynamic course gives you the knowledge to navigate one of the most heavily regulate … Course ID: CT03A |
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Introduction to AI Regulatory Compliance Management: The Expert-in-the-Loop (EIL)Artificial intelligence is rapidly transforming the life sciences industry – from pharmaceutical manufacturing and medical devices to clinical research and regulatory operations. As AI, machine learni … |
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AI Quality Regulatory Compliance Management Professional Certification ProgramThe AI Quality Regulatory Compliance Management Professional Certification Program is designed to prepare life sciences professionals for one of the most important emerging roles in regulated industry … Course ID: AI-201 |
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AI Applications and Quality Management in GxP EnvironmentsAI (artificial intelligence) Applications and Quality Management in GxP Environments is a practical, forward-looking eLearning course designed for professionals working in pharmaceutical, biotechnolog … Course ID: AI-501 |

































