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, CFR Part 820, Cleaning Validation, or Drug Safety.
|
Or Download Catalog:
  |
Searching courses for: Pharmacovigilance
 |
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 … |
 |
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 … |
 |
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 … |
 |
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 … |
 |
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 … |
 |
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 … |
 |
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 … |
 |
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 … |
 |
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 … |
 |
Regulatory Affairs: Essentials for Human Medicinal Products – EU and USThis foundation-level training program is the ideal introduction for entrants new to the field of pharmaceutical compliance and regulatory affairs. It describes the principal requirements needed in or … |
