Pharmacovigilance for Drug Safety, Regulatory Affairs and PV Auditors - Broadening your Knowledge Training Course

Background and Introduction to Pharmacovigilance

• The WHO and Safety Reporting
• CIOMS – Function and Purpose
• ICH – Composition and Guidelines

Global Pharmacovigilance and Safety Standards

• Definitions of Terms (ICH) used in Pharmacovigilance
• Adverse reactions versus Adverse events
• Serious and Non-serious – definitions
• Expected or unexpected reactions or events
• Expedited reporting

Global Pharmacovigilance and Safety Standards (continued)

Pharmacovigilance and its Role in Other Departments

• Pharmacovigilance – where does it fit in the Company?
• Medical Information and Drug Safety
• Regulatory Dept. and Drug Safety
• Clinical and Drug Safety
• Commercial, Marketing and Drug Safety

Clinical Drug Safety  

• Basic principles – key features for capturing Drug Safety data
• Case Record Form Design and Data Capture
• Data Management and Drug Safety – Clinical versus Safety Databases
• Assessment of Individual Serious Adverse Event Reports

Post Marketing Drug Safety

• Differences in Clinical and Post Marketing Drug Safety
• European Marketing Safety and Causality
• Post Marketing Safety in the USA
• Post Marketing Safety in Japan

Causality Assessments in Pharmacovigilance

• Assessments for Clinical Safety and Causality
• Post Marketing Safety and Causality
• Causality Definitions
• Company versus Reporter Causality
• Pros and Cons of Causality Definitions

Pre-Clinical Animal and In vitro Studies

• ICH Guidelines and Animal and In vitro Studies
• EU and FDA regulations and Animal Studies
• Toxicity Studies
• Genotoxicity, mutagenicity and Carcinogenicity Studies

MedDRA – Introductory

• Background Information concerning the Introduction of MedDRA
• The MSSO and MedDRA
• MedDRA Coding capabilities and approaches
• MedDRA Versions and Development of the Dictionary
• Old Dictionaries and Data Conversion

Collecting Good Quality Safety Information

• Why the need for good Quality Safety Information?
• What constitutes good safety information?
• Differing regulations concerning safety data collection requirements
• Designing a system to collect good quality information

The Blinded Study and Safety Reporting

• Definition of a Blinded Study
• Blinded Studies involving Company Product, Comparator Product and Placebo
• Regulations and Guidelines for Blinded Study Safety Reporting
• Unblinding and Emergency Unblinding
• Blinding and Biometrics

An Introduction to Medical Device Reporting

• Definition of a Medical Device
• Safety Reporting of Medical Devices
• FDA Regulations concerning Medical Devices and Safety
• EU Regulations concerning Medical Devices and Safety

The Need for Capturing Pregnancy Data

• Pregnancy Information Sources
• Pregnancy Data Forms, data capture and appearance in Safety Reviews
• Regulations concerning pregnancy data capture

Drug Safety and At Risk Groups

• Regulations and Guidelines in connection with At Risk Groups
• Analysis of Data from at risk Groups
• Identification of at Risk Groups
• Reporting new findings concerning at risk groups

Medical Aspects of Liver Disease and Hepatic Adverse Drug Reactions

• Basic Physiology and Definitions
• Common Liver Conditions
• Drug effects on the Liver
• Pharmacovigilance evaluations with Hepatic ADRs

Medical Aspects of Renal Adverse Drug Reactions

• Basic Renal Physiology
• Drug Induced Renal Disease
• Renal Disease and ADRs
• Renal Function and Dosing in relation to ADRs

Medical Aspects of Haematological and Immunological Adverse Drug Reactions

• Blood Composition and Normal values
• Mechanism of action of Drugs on Blood Parameters
• Type A and B reactions

Medical Aspects of Cardiovascular Disease and Adverse Drug Reactions

• Basic Physiology and Heart Rhythm
• QT Interval Prolongation and Drugs
• Cardiovascular Disease and Drugs – contraindications
• Drug Induced Cardiac ADRs