Description
This 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 descriptions of drug safety, pharmacovigilance, pharmacokinetics, and pharmacodynamics.
Pharmacoepidemiology 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 evidence of the safety, efficacy and utility of medicinal products has focused greater attention on pharmacoepidemiological research. This program will assist those who plan and conduct such research, and analyze and report the findings, with how to follow good practices in doing so.
Pharmacokinetic (PK) and pharmacodynamic (PD) studies provide a bridge between science and medicine in the development of a drug. In this course we move on to describe the role of in-vivo PK and PD studies in a drug development program, set out the uses to which the findings can be put, and discuss their implications for clinical development and application for marketing approval.
This program extends the learner’s understanding of pharmacokinetic and pharmacodynamic studies by detailing the variety of aspects of such studies, including: design, sampling, data analysis, research in special populations, and bioequivalence testing.
This program moves on and 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 how sponsors should report to regulatory authorities and other stakeholders in the safety of investigational products. It explains how events are characterized as serious or non-serious, expected or unexpected, and it distinguishes the requirements for each category. It describes controlled vocabularies used for coding of events in reports. Furthermore, this program will set 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.
Individual courses contained within this program are as follows: 1) Introduction to Drug Safety and Pharmacovigilance; 2) Urgent Safety Restrictions; 3) Risk Management Planning for Medicinal Products; 4) Signal Detection and Management in the Pharmacovigilance; 5) An Introduction to Pharmacokinetics and Pharmacodynamics in Drug Development and Registration; 6) Conducting Pharmacokinetic and Pharmacodynamic Studies; 7) Good Pharmacoepidemiology Practice; 8) Safety Reporting in Clinical Trials (Adverse Event Reporting); and 9) Clinical Trial Safety Reporting Requirements in the EU and USA.
