Essentials of Pharmacovigilance

The module introduces the purposes and key practices of pharmacovigilance (PV) and drug safety. It describes the classification of adverse events (AEs) and adverse drug reactions (ADRs) while examining hypothesis generation and confirmation methods used in PV. The module concludes by examining some of the challenges that the fields of PV and drug safety face.

Recommended Use: Required
ID (Language): 21077 (English)
Author(s): Akshita Srivastava, MSc - DDReg Pharma Pvt. Ltd.

This module describes elements of a valid ICSR. It defines the key steps involved in ICSR processing and examines various case scenarios where an ICSR can be generated. It includes a discussion of the Medical Dictionary for Regulatory Activities (MedDRA) and its use for coding ICSRs. The module concludes by detailing the U.S. Food and Drug Administration (FDA) requirements for ICSR submissions.

Recommended Use: Required
ID (Language): 21078 (English)
Author(s): Akshita Srivastava, MSc - DDReg Pharma Pvt. Ltd.

This module describes different sources of adverse event (AE) reports, including those deriving from passive and active surveillance. It examines different adverse drug reaction (ADR) reporting systems and details the U.S. Food and Drug Administration (FDA) requirements for postmarket reporting. Additionally, the module discusses the types and uses of MedWatch forms.

Recommended Use: Required
ID (Language): 21079 (English)
Author(s): Akshita Srivastava, MSc - DDReg Pharma Pvt. Ltd.

The module describes key safety databases and surveys the evolution of pharmacovigilance software. It explains the advantages of artificial intelligence and machine learning and outlines the implications of systems of intelligence for postmarket surveillance and reporting. The module concludes by exploring the prospects of new technologies in pharmacovigilance.

Recommended Use: Required
ID (Language): 21080 (English)
Author(s): Akshita Srivastava, MSc - DDReg Pharma Pvt. Ltd.

This module explains the format and presentation of different postmarketing aggregate reports. It describes the requirements and timelines for aggregate report submissions. The module also details the contents of risk management plans (RMPs) and risk evaluation and mitigation strategies (REMSs).

Recommended Use: Required
ID (Language): 21081 (English)
Author(s): Akshita Srivastava, MSc - DDReg Pharma Pvt. Ltd.

The module explains the purpose of a robust pharmacovigilance QMS and describes its key components. It discusses the uses of root cause analysis (RCA), corrective, preventative action plans (CAPAs), and independent auditing. It identifies the responsibilities of those who manage and maintain QMSs. Additionally, it details the international guidelines related to a pharmacovigilance QMS.

Recommended Use: Required
ID (Language): 21082 (English)
Author(s): Akshita Srivastava, MSc - DDReg Pharma Pvt. Ltd.

This module examines the FDA’s regulation of marketing authorization holders (MAHs) postmarket behavior. It explains the function of postmarket studies and risk identification and mitigation measures. Additionally, the module describes the kinds of drug safety information communicated to physicians and the general public. It concludes by identifying the actions that the FDA takes when regulations are not followed.

Recommended Use: Required
ID (Language): 21083 (English)
Author(s): Akshita Srivastava, MSc - DDReg Pharma Pvt. Ltd.

The module focuses on pharmacovigilance practices and regulations outside of the U.S. It details pharmacovigilance in the European Union, with a focus on the Eurpean Medicines Agency’s (EMA) Good Pharmacovigilance Practices (GVP) guidelines and the EudraVigilance Database. The module surveys postmarket activities in the United Kingdom, Northern Ireland, Australia, Japan, India, China, Singapore, the Middle East, and Latin America.

Recommended Use: Required
ID (Language): 21084 (English)
Author(s): Akshita Srivastava, MSc - DDReg Pharma Pvt. Ltd.

This module defines materiovigilance and explains its implications for the medical device industry. It describes materiovigilance processes and practices in the U.S., including post-approval studies, reporting requirements, safety databases, user reports, surveillance mechanisms, and risk management activities.

Recommended Use: Supplemental
ID (Language): 21085 (English)
Author(s): Akshita Srivastava, MSc - DDReg Pharma Pvt. Ltd.

The module turns its focus to postmarket surveillance and regulations of medical devices outside of the U.S. It examines the approaches to materiovigilance in the European Union, India, China, Japan, Australia, and Canada, noting similarities and differences across regulatory systems. The module concludes by exploring global harmonization efforts.

Recommended Use: Supplemental
ID (Language): 21086 (English)
Author(s): Akshita Srivastava, MSc - DDReg Pharma Pvt. Ltd.