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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, CFR Part 820, Cleaning Validation, or Drug Safety.
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Searching courses for: Drug Safety
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Introduction to Drug Safety and PharmacovigilanceDrug safety monitoring and risk management are vitally important for medicinal product developers, license holders and clinical investigators. In addition to their duty to protect public health, incre … |
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Drug Safety and Pharmacovigilance Professional Certification ProgramThis training program provides a comprehensive overview of the requirements and concepts necessary to attain a strong understanding of drug safety and pharmacovigilance.Drug safety monitoring and risk … |
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Clinical Trial Safety Reporting Requirements in the EU and USAThis course sets out the legal and regulatory requirements for safety reporting in clinical trials of medicinal products under the jurisdictions of the European Union and the USA. It builds on the fou … |
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Safety Reporting in Clinical Trials (Adverse Event Reporting)This course explains the regulatory requirements for the reporting of adverse events and suspected adverse reactions in clinical trials. It describes how investigators should report to sponsors, and h … |
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Introduction to Pharmacokinetics and Pharmacodynamics in Drug Development and RegistrationPharmacokinetic (PK) and pharmacodynamic (PD) studies provide a bridge between science and medicine in the development of a drug. In this module we describe the role of in-vivo PK and PD studies in a … |
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Drug Safety: Signal Detection and Management in PharmacovigilanceThe fundamental aim of drug safety assessment is to establish what adverse reactions may be caused by a medicinal product. Factors such as seriousness, severity, and frequency of reactions are then ta … |
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Drug Safety: Urgent Safety RestrictionsIn response to a safety signal, a regulatory action, called the Urgent Safety Restriction (USR), is taken. This action is intended to push an interim change to the marketing authorization’s terms for … |
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Good Pharmacoepidemiology Practice Professional Certification ProgramThis program provides a comprehensive overview of the requirements and concepts necessary for a strong understanding in good pharmacoepidemiology practice (GPP). The program also includes detailed des … |
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The 505(b)(2) Application for Marketing Approval in the USAA 505(b)(2) New Drug Application (NDA) is a submission to the Food and Drug Administration (FDA) for approval to market a drug in the USA. It differs from a ?stand-alone? NDA in that some of the data … |
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GMP Awareness: Food ManufacturingcGMP stands for current Good Manufacturing Practices. In the USA, for food manufacturing, these are prescribed by the Code of Federal regulations, 21 CFR Part 117. Prior to this the GMPs were publishe … |
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Clinical Trials: The Investigational New Drug Application (IND) to Conduct FDA-regulated Clinical TrialsThe Investigational New Drug Application (IND) is a submission through which the sponsor seeks approval from the Food And Drug Administration (FDA) to conduct clinical studies with an investigational … |
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The Biologics License Application (BLA) for Marketing Approval in the USABiological products have come to dominate the market for medicines in recent decades. To introduce a biological product into interstate commerce in the USA, the sponsor of the product must gain FDA ap … |
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GxP: Good Practices (GxP) in Drug Development and ManufacturingThis short entry-level module introduces the learner to good practices (GxP) in drug development and manufacturing. It outlines how the industry operates and how it is regulated. It identifies regulat … |
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GMP: Food Manufacturing for Professionals (21 CFR Part 117)cGMP stands for current Good Manufacturing Practices. In the USA, for food manufacturing, these are prescribed by the Code of Federal regulations, 21 CFR Part 117. Prior to this the GMPs were publishe … |
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Drug Safety: Risk Management Planning for Medicinal ProductsProactive risk management is a major component of good pharmacovigilance practice (GVP). This course sets out the principles of risk management planning and outlines regulatory requirements for risk m … |
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Drug Safety: Good Pharmacoepidemiology PracticePharmacoepidemiology is the study of the use and effects of drugs in large numbers of people. It provides a bridge between clinical pharmacology and epidemiology. The increasing demand for real-world … |
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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 … |
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Medical Device vs. Drug: Comparing and ContrastingThis course covers major differences between medical device and drug clinical trials, including key definitions, regulatory approval and application processes, and safety reporting, with a focus on F … |
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Clinical Trials: Preparing for an Audit or InspectionGood Clinical Practice (GCP) inspections and audits are carried out to provide assurance that: the rights, safety and welfare of clinical trial subjects are protected; the data that constitute the res … |
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Overview of ICH E8(R1): General Considerations for Clinical Studies GuidelineICH E8(R1) is the umbrella guideline that maps to all the ICH “E” family, including ICH E6(R3), Good Clinical Practice. The revision modernizes clinical trial design, planning, management, conduct, an … |
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Investigator Initiated Clinical TrialsWhat are investigator initiated trials, and are they truly initiated by investigators, or by industry sponsors? Investigators may have an idea for a clinical trial with an investigational or approved … |
