Читать книгу Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) - William Gregory - Страница 6
Contents
ОглавлениеChapter 1The Theory and Definitions of Drug Safety — Pharmacovigilance
Adverse Event/Experience (AE) — FDA
Serious Adverse Event and Serious Adverse Reaction (SAE/SAR)
Non-serious Adverse Event and Non-serious Adverse Reaction (NSAE/NSAR)
Suspected Adverse (Drug) Reaction (SAR/SADR) — FDA
Serious, Unexpected, Suspected Adverse Reaction (SUSAR)
Serious, Expected, Suspected Adverse Reaction
Unexpected Adverse Event — FDA
Unexpected Adverse Reaction — EMA
Unlisted Adverse Reaction — EMA
Expected (Listed versus Labeled)
Investigator-Initiated Research
Chapter 3Spontaneous Post-marketing Adverse Events
Chapter 4The Theory of Drug Safety — Pharmacovigilance
Regulations, Laws, and Guidances
The United States Regulations and Guidances
The European Union Legislation (including Directives and Regulations), and Guidance
Chapter 5The Mathematics of Adverse Events and a Brief Note on Pharmacoepidemiology
Case Report or Individual Case Safety Report
Why We Can’t Calculate Good Rates
Quantitative Signal Detection Methods
Chapter 6Epidemiology and Pharmacoepidemiology: What Are They?
What Are Their Limitations and Advantages?
Chapter 7Regulations, Directives, Guidance, Laws and Consensus Documents
Chapter 8The United States Food and Drug Administration
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
Center for Devices and Radiologic Health
Prescription Drug User Fee Act
Prescription Drug User Fee Act: Five-Year Plan
Food and Drug Administration Act (FDAAA) of 2007
FDA Reauthorization Act of 2017
What is Expected from Drug Companies by the FDA?
What is Expected from Consumers and Healthcare Professionals by the FDA?
Chapter 9The European Medicines Agency
Registration Procedures in the EU
EudraVigilance — The EU Safety Database
What Is Not in the Scope of EMA?
The Pharmacovigilance Risk Assessment Committee
Post-marketing PV EU Regulation
European Network of Centers for Pharmacoepidemiology and Pharmacovigilance
Agence Nationale de Sécurité des Médicaments et Produits de santé
Chapter 10The EU Qualified Person for Pharmacovigilance
Frequent QPPV Inspection Findings by the EMA
Chapter 11The Uppsala Monitoring Centre
WHO Programme for International Drug Monitoring
Chapter 12Council for International Organizations of Medical Sciences
CIOMS I (1990): International Reporting of Adverse Drug Reactions
CIOMS II (1992): International Reporting of Periodic Drug-Safety Update Summaries
CIOMS IV (1998): Benefit–Risk Balance for Marketed Drugs: Evaluating Safety Signals
CIOMS V (2001): Current Challenges in Pharmacovigilance: Pragmatic Approaches
CIOMS VI (2005): Management of Safety Information from Clinical Trials
Regulatory Reporting and Communications of Safety Information from Clinical Trials
CIOMS VII (2006): Development Safety Update Report (DSUR)
CIOMS IX (2014): Practical Approaches to Risk Minimization for Medicinal Products
CIOMS X (2016): Evidence Synthesis and Meta-analysis
CIOMS (2017): Guide to Active Vaccine Safety Surveillance
FDA Adverse Event Reporting System
General Practice Research Database and Clinical Practice Research Datalink
Other Registries and Databases
Chapter 14Information Technology, Databases, and Computers
Required Safety Database Functionality
Vendor Support and Information Technology Issues
Clinical Data Interchange Consortium
Systematized Nomenclature of Medicine Clinical Terms
Other Manufacturers’ Drugs’ AEs
Placebo and Breaking the Blind in Clinical Trials
Picking up AEs Due to Excipients
Adverse Events with Counterfeit, Impure, and Other Non-standard Products
Authors’ Comments for PV Personnel
Chapter 16Children, Elderly, and Other Special (Vulnerable) Groups
Children
FDA Guidance and Geriatric Rule
Chapter 17Pregnancy and Lactation
Situation in the United States
Females and Males of Reproductive Potential
FDA Guidance on Pregnancy Registries — 2002
Regulatory Reporting Requirements
Situation in the European Union
AEs in Pregnant Partners of Males Taking a Drug
Teratology Registries and Organizations
Market Removal
Return to the Market in Canada and Europe
Delayed Onset of Malignancy (Long Latency)
Drug–Food, Drug–Alcohol, Drug–Disease and Other Interactions
Chapter 20Product Quality Issues
Chapter 21AE Volume, Quality, Good Documentation Procedures, and Medical Records
Chapter 22Seriousness, Expectedness, and Causality
Health Authority Guidance and Requirements
CIOMS I Assessment of Causality
Uppsala Monitoring Centre (WHO)
Judgment of Cases When Received Versus at the Time of Periodic Reporting and Signaling
Chapter 23Coding of Adverse Events and Drug Names
MedDRA
Standardized MedDRA Queries (SMQs)
Systematized Nomenclature of Medicine — Clinical Terms
Drug Names and Drug Dictionaries
Multiple Names and Name Changes
EudraVigilance Medicinal Product Dictionary
Chapter 24Expedited and Aggregate Reporting in Clinical Trials
United States Requirements for Expedited IND Reports
Expedited IND Reports (Alert Reports, 7-Day and 15-Day IND Reports)
Other Clinical Trial (IND) Reporting Issues
Expedited Reporting in Clinical Trials
Development Safety Update Reports
When to Start Collecting Serious AEs in Trials
Chapter 25Post-marketing Spontaneous ICSR/SAE Reporting
Post-marketing ICSRs versus Clinical Trial ICSRs
Notes on United States Requirements for Post-marketing NDA Reporting of SAEs
MedWatch to Manufacturer Program
Reports from the FDA via the Freedom of Information Act
Instructions on Filling Out the MedWatch Form
Post-marketing Periodic Reports
Section 1: Narrative Summary and Analysis
Section 2: Narrative Discussion of Actions Taken
Periodic Safety Update Reports
PSUR in ICH E2C(R2) Format: The Periodic Benefit–Risk Evaluation Report
Chapter 27Signals and Signaling in the Context of Risk Management
The Conclusions and Next Steps
Computerized Tools for Signal Detection and Workup
Key Documents on Signaling and Good PV Practices
FDA Guidance on Good Pharmacovigilance Practices of 3/2005
EU GVP Module IX — Signal Management (2012: Revision 1, Delivered Nov 2017)
Roles of Key REMS Participants
Part I: Product(s) Overview (GVP V. B.4)
Part II: Safety Specification (GVP V.B.5)
Part III: PV Plan, Including Post-authorization Safety Studies (GVP V.B.6 RMP part III)
Part IV: Plans for Post-authorization Efficacy Studies (GVP V.B.7 RMP part IV)
Part VI: Summary of the RMP (GVP V.B.9 RMP part VI)
Practicalities, Co-ordination, and Other Comments
Risk Management within Pharma Companies
Chapter 29Data Monitoring Committees and Investigational Review Boards/Ethics Committees
Data Monitoring Committees
Investigational Review Boards/Ethics Committees
Chapter 30Pharmaceutical Companies
Contract/Clinical Research Organizations
Mergers, Acquisitions, and Bankruptcies
Chapter 31Organization of a Typical Drug Safety Department
Qualified (Responsible) Person for Pharmacovigilance
Case Assessment and Prioritization
Signaling, Pharmacovigilance, Pharmacoepidemiology, Medical Information or Medical Affairs Unit
Labeling Review and Update for Safety
Information Technology/Informatics Liaison
Quality Documents Creation and Maintenance
Safety (AE) Exchange Agreement Function: Creation and Maintenance
Planning and Project Management/Operations
Liaison to External Organizations/Drug Safety Intelligence
PV Worker Education, Skills, and Profile
Chapter 32How an Individual Case Safety Report (ICSR) is Handled from Start to Finish
AE Sources and Arrival in the Safety Department
Case Distribution and Transmission
15 Calendar Days and Day 0 versus Day 1
Organizational Structure and Site Information
Computer, Forms, Electronic, and Print Resources
Corporate and Drug Safety SOPs, Working Documents, Guidelines, and Manuals
Medical Dictionary for Regulatory Activities (MedDRA®) and Other Dictionaries
Signaling and Pharmacovigilance
Chapter 35Audits and Inspections
The Response to the Inspection or Audit
The Corrective Action Preventive Action Plan (CAPA)
Comments on EMA and MHRA Inspections
Quality Systems and Inspection Preparation in Companies
Chapter 36Pharmacovigilance System Master File
Pharmacovigilance System Master File (Guideline on Good
Pharmacovigilance Practice Module II)
Chapter 37Ethical Issues and Conflicts of Interest
Dynamics in Play in Regard to Drug Safety and Companies
Data Safety Management Boards and Ethics Committees/Institutional Review Boards
Dynamics in Play in Regard to Drug Safety and Health Agencies
Dynamics in Play in Regard to Drug Safety and Academic and Non-academic Healthcare Facilities
Dynamics in Play in Regard to Drug Safety and Lawyers/Litigation
The Quality and Compliance Department
Signaling and Epidemiology Groups
The Medical Information/Medical Affairs Department
Manufacturing (Product Quality Complaints)
Company Core Safety Information
United States Safety Labeling for Marketed Products
European Union Safety Labeling for Marketed Products
Comments about Labeling Content
OTC Labeling in the United States
Chapter 40Universities and Academic Medical Centers
The Bayh–Dole Act in the United States
Clinical Research Units/Academic Study Units
Drug Safety Training in Academia
North America
Differences between Vaccinovigilance and Pharmacovigilance
Drugs are Metabolized; Vaccines are Processed
Incidence and Prevalence of Adverse Event Symptoms
United States Initiative: The Vaccine Adverse Events Reporting System
GACVS and the European Commission
Vaccine Adverse Event Reporting
Sources of Additional Information
Chapter 42Business Partners and Exchange of Safety Data
Why a Written Safety Exchange Agreement is Needed
Telling the Safety Department about a New Contract or Arrangement
The Generic, Boilerplate, or Template Agreement
Developing a Safety Agreement with the Safety Department
Pharmacovigilance Agreement Database
Health Authority Queries and Requests
Data and Mechanisms of Data Exchange
Signaling, Safety Reviews, and Risk Management
Chapter 43Data Privacy and Security
United States Health Insurance Portability and Accountability Act (HIPAA)
The European Union and the Privacy Regulation & Directive
Litigation, Lawyers, and Legalities
Organizations for Drug Safety Personnel
Chapter 45Real-World Issues: Case Studies
Fialuridine
Chapter 46Medical Marijuana and Pharmacovigilance
Overview and Pharmacology
US Federal Regulatory Situation
Chapter 47International Council for Harmonisation (ICH)
E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
The E2B(R3) and ISO/HL7 Documents
E2C(R2) Periodic Benefit-Risk Evaluation Report and E2C(R2) Q&As
E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER)
E2D: Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting
Sources of Individual Case Safety Reports
Standards for Expedited Reporting
Good Case Management Practices
E2E: Pharmacovigilance Planning
The Sections of a Pharmacovigilance Plan
E2F: Development Safety Update Report
E19: Optimisation of Safety Data Collection
M1: MedDRA® Terminology (Medical Dictionary for Regulatory Activities)
