Bibliographic record and links to related information available from the Library of Congress catalog.
Note: Contents data are machine generated based on pre-publication provided by the publisher. Contents may have variations from the printed book or be incomplete or contain other coding.
Chapter 1. The Theory & Definitions of Drug Safety (Pharmacovigilance) The Theory Adverse event Adverse reaction Serious Adverse Event (SAE) and Serious Adverse Reaction (SAR): Suspected Adverse Drug Reaction (SADR) Serious, Unexpected Adverse Drug Reaction (SUSAR) Serious, Expected Adverse Drug Reaction (SESAR) Unexpected Expected The Practice Chapter 2. Clinical Trials, CROs, Phases I-IV, Investigator Initiated Trials The Theory Phase I Phase II Phase III Phase IV Investigator-Initiated Trials (IITs) or Studies (IISs) The Practice FAQs Chapter 3. Spontaneous, post-marketed AEs. Background The Theory The Practice Chapter 4. The Theory of Drug Safety (Pharmacovigilance) Background The Theory The US Regulations & Guidances The European Union directives, regulations and guidances The Practice FAQs Chapter 5. AEs with new chemical entities, generics, excipients and placebos Background The Theory Generics Excipients Placebo Other manufacturers¿ AEs The Practice Placebo Excipients Generics FAQs Chapter 6. Acute and Chronic (Late Occurring) AEs, AEs that disappear (Bendectine ¿), Diethylstilbesterol (DES) Background The Theory The Practice Adriamycin Gene Therapy Anti-Retroviral Drugs Diethylstilbesterol (DES) Delayed Onset of Malignancy (Long Latency) Actions Taken Bendectin¿: A False Alert Return to the Market in Canada The Future FAQ Chapter 7. The Mathematics of AEs. Background Weber Effect Secular Effects The Theory The Practice Chapter 8. Organizations: The Food and Drug Administration (FDA). MedWatch Background The Theory CDER Risk Management MedWatch FDA Safety Databases Drugs Biologics CBER What is Expected from Drug Companies by FDA Clinical Trials - AEs reported to the IND Marketed drugs - AEs reported to the NDA What is Expected from Consumers & Health Care Professionals by the FDA Product Safety News The Practice FAQ Chapter 9. Organizations: European Medicines Evaluation Agency Background The Theory EudraVigilance Risk Management Qualified Person The Practice FAQ Chapter 10. Where data resides. Background The Theory The Practice US Food and Drug Administration The Uppsala Monitoring Centre (UMC) Chapter 11 Signals and signaling in the context of Risk Management Background The Theory The Signal Signal Generation Increase Frequency Data Mining Signal Work-up The FDA Guidance on Good Pharmacovigilance Practices of 3/05 Investigating a Signal Interpreting a Signal The Practice FAQ Chapter 12. Data privacy and sharing. Background The Theory HIPAA The European Union Privacy Directive The Practice Chapter 13. The roles of academia, companies, government health authorities, non-governmental organizations (NGOs), consumer groups and gadflies in the world of pharmacovigilance Background The Theory The Practice FAQ Chapter 14. Risk: What is it? Risk management and assessment Background The Theory The Practice Chapter 15. FDA¿s Premarketing Risk Assessment Guidance of March 2005. Background The Theory and The Practice Pre-marketing Risk Assessment Size of the Safety Database Long-term controlled safety trials Diversity Exploring Dose Effects Drug Interactions Comparative Safety Data Special Circumstances ¿Large Simple Safety Studies¿ (LSSS) Medication Errors Assessing safety during product development Biologic products may require additional testing Data Analysis and Interpretation Describing AEs to identify signals (Coding) Coding Accuracy Coding Analysis Analyzing temporal and other associations Analyzing dose effect Data Pooling Rigorous ascertainment of reasons for withdrawals from studies Long term follow- up Important Aspects of Data Presentation Chapter 16. FDA¿s Development and Use of Risk Minimization Action Plans. Guidance of March 2005. Background The Theory and The Practice Planning in designing a Risk MAP Goals Objectives Tools Targeted education and outreach Reminder systems Performance-linked access systems When to Develop a RiskMAP Mechanisms available to FDA to minimize risks Assessing the Effectiveness of the Tools and the Plan Evaluating Effectiveness of the RiskMAP FDA Assessment and publication of RiskMAP results The Practice Chapter 17. FDA¿s Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment Guidance of March 2005. Background The Theory and The Practice Identifying Signals: Good Reporting Practice Developing a Case Series Data Mining Safety signals that may warrant further investigation Reporting rates vs incidence rates Epidemiologic Studies Pharmacoepidemiologic Studies Registries Surveys Interpreting signals Developing a Pharmacovigilance Plan Chapter 18. Epidemiology and Pharmacoepidemiology. What are they? What are their limitations and advantages? The Theory and The Practice Case Report Aggregate Reports Randomized Clinical Trial (RCT) Case-Control Study Cohort study Nested case-control study Confidence interval Chapter 19. Product Quality Issues Background The Theory The Practice Chapter 20. Pregnancy, lactation and AEs. AEs in pregnant partners of males taking a drug. Pregnancy registries. The Swedish Pregnancy Registry Background The Theory FDA Pregnancy Categories (Table 20.1) FDA Guidance for Industry ¿ 2002 Regulatory Reporting Requirements Lactation AEs in pregnant partners of males taking a drug The Practice FAQs Chapter 21. Children, the elderly and other special groups Background The Theory Children The Elderly The ICH & FDA Guideline FDA Guideline & Rule The Practice Children The Elderly Other Special Groups Women African-Americans Chapter 22. Drug Interactions and Polypharmacy Background The Practice Chapter 23. Drug labeling, warnings, etc. Physicians¿ Desk Reference (PDR) and equivalents. Differences from country to country. Background and Theory The Practice Chapter 24. Regulations, directives, guidances, law and practice in the EU and US. CIOMS and ICH documents. What is written down and what is traditional practice. Background and Theory United States European Union The Practice Chapter 25. CIOMS & CIOMS Reports Council for International Organizations of Medical Sciences (CIOMS) CIOMS I (1990) International Reporting of Adverse Drug Reactions CIOMS II (1992) International Reporting of Periodic Drug-Safety Update Summaries CIOMS III (1995 & 1998/9) Guidelines for Preparing Core Clinical-Safety Information on Drugs (1995) - Including New Proposals for Investigator's Brochures (1998/9). 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 CIOMS VII (Ongoing) Developmental Safety Update Report (DSUR) Chapter 26. ICH Reports International Conference on Harmonization (ICH) Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (E2A) Definitions What should be reported to regulatory authorities as expedited reports? Reporting Time Frames Minimum Criteria for Reporting Managing Blinded Cases Other Issues Data Elements for Transmission of Individual Case Safety Reports (E2B) and Message Specification Technical Details (M2) The E2B (¿medical¿) documents The M2 (Informatics) Documents Periodic Safety Update Reports (PSURs) for Marketed Drugs (E2C) Periodic Safety Update Reports for Marketed Drugs (Addendum to E2C) Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting E2D Pharmacovigilance Planning E2E Chapter 27. Pharmaceutical Companies Big and Somewhat Big Pharma Generic Companies Mid and Small Size Pharma Clinical or Contract Research Organizations (CROs) Chapter 28. Universities and Academic and Non-Academic Medical Centers Discovery & Licensing Clinical Research Units/Centers (CRUs/CRCs) Other Divisions Running Studies Training Medical Students, Pharmacists, Nurses, Epidemiologists and other Health Care Professionals Ethics Committees/Institutional Review Boards (IRBs) Data (Safety) Monitoring Committees (DSMC or DMC) Consultation to the Industry Reporting Adverse Events that Occur in the Hospital Chapter 29. Organization & structure of a typical safety department The Standard Units/Functions Management Triage Group Case Assessment & Prioritization Data Entry Group Case Processing Group Medical Case Review Transmission Unit Regulatory Unit Legal Unit Signaling/Pharmacovigilance/Pharmacoepidemiology/Medical Affairs Unit Aggregate Report Preparation Labeling Review & Update for Safety Archive/File Room Information Technology/Informatics Liaison SOP Creation & Maintenance Training Quality Assurance/Control Adverse Event Exchange Agreement Function: creation & maintenance Literature Review Data Dictionary Maintenance Coding Unit Planning & Project Management/Operations Liaison to External Organizations: CIOMS, ICH, PhRMA etc. Chapter 30. Business partners and AE exchange agreements Hubs vs Direct Party to Party Exchange Timing & Documents Exchanged Chapter 31. Computers, Informatics, Validation, Data Entry. E2B Database Needs and Functions Information Technology (IT)/Informatics Support Privacy Data Entry Strategy E2B Chapter 32. SOPs, guidelines, etc. Version Control, Numbering, Updating, Training Quality Working with Business Partners SOPs for Drug Safety Chapter 33. Training Drug Safety Other Groups Typical Curriculum for a New Hire in Drug Safety Organizational Structure & Site Information Computer/Forms/Electronic & Print Resources What is pharmacovigilance? Corporate & Drug Safety SOPs MedDRA and other dictionaries Safety Database Workflow Signaling and Pharmacovigilance Chapter 34. The Safety department¿s role in clinical research, marketing and sales, labeling, regulatory, due diligence and legal issues Clinical Research Marketing and Sales Labeling Legal Regulatory Affairs Quality and Compliance New Business Due Diligence Reviews Manufacturing (complaints) Chapter 35. AE volume, quality and medical records Quality and Completeness Medical Records & Archiving Chapter 36. How an AE is handled in the company from start to finish Mission and Goals Arrival of AEs from Various Sources Call Centers AE Triage (Case Assessment) Data Entry Data Review and Quality Checks Medical Review Case Closure/Completion Distribution & Submission Tracking and Metrics Timing Special Situations Database Lock Investigator Notification 15 Calendar Days and Day 0 vs Day 1 Chapter 37. Seriousness, expectedness and causality Seriousness Expectedness (Labeledness) Causality (Relatedness) Casualty Reporting Recommendations US FDA European Union CIOMS 1 Assessment of Casualty Others Algorithms Global Introspection Over The Counter (OTC) Drugs Chapter 38. Coding of AEs: MedDRA® & coding conventions. Conventions and arbitrary usage. Drug dictionaries & drug naming problems. When a drug has a different name in different countries. Browsers Coding Drug Codes Multiple Names Name Changes WHO Drug Dictionary EudraVigilance Medicinal Product Dictionary Chapter 39. IND Reports: 7 and 15 day reports. IND annual reports Investigational New Drug Application (IND) Reports Expedited IND reports (Alert Reports, 7 and 15 day IND Reports) IND Annual Reports Other Clinical Trial (IND) Reporting Issues Blinding and Unblinding 7 and 15 day alert reports SAE reporting after the end of the of the trial When to start collecting SAEs in trials Chapter 40. NDA Reports: 15 day alert reports. Feeder Groups Literature and Publications MedWatch to Manufacturer Program: Reports received from FDA Reports received from the FDA via the Freedom of Information Act (FOI) Collection of Reports Parent-child/fetus reports Follow-up Instructions on filling out the MedWatch form Chapter 41. NDA Reports: Periodic Reports NDA Periodic Reports Post-Marketing Period Report Section 1: Narrative summary and analysis Section 2: Narrative discussion of actions taken Section 3: Index line listing Section 4: FDA Form 3500As or VAERS forms Other Reports Distribution reports Annual Reports Chapter 42. The Tome. FDAs proposed 2003 regulations Definitions IND Safety Reports Post-Marketing Reporting Exedited Reports Contractors and Sharded Manufacturers Prescription Drugs Marketed without an Approved Application SADRs from Class Action Lawsuits Blood Products Post-Marketing Periodic Safety Reports Semiannual Reports Old Drugs (BEFORE 1/1/98): Traditional NDA Periodic Reports now called TPSRs New Drugs (AFTER 1/1/98): PSURs Interim Periodic Safety Reports Forms Record Keeping ANDAs Annual Report In Vivo Bioavailability and Bioequivalence Studies Chapter 43. Periodic Safety Update Reports (PSURs) Chapter 44. Business Partners and Exchange of Safety Data. Due Diligence. Why a written safety exchange agreement is needed Telling the Safety Department about a New Contract The Generic or Boilerplate or Template Agreement Developing a Safety Agreement with the Safety Department The Safety Agreement Database The Safety Agreement Contents The Regulatory Status The Regulatory Responsibilities Regulatory Documents Health Authority Queries and Requests Regulatory Submissions Investigator and IRB/Ethics Committee Notifications. Blinding and Unblinding Databases Definitions Data and mechanisms of data exchange Signaling and Safety Reviews Other Issues Appendices Chapter 45. Audits and Inspections FDA Inspections EMEA Inspections Internal Inspections Company Inspection Procedures Chapter 46. Ethical issues. Conflicts of Interest. Some of the dynamics at play in regard to drug safety and companies Some of the dynamics at play in regard to drug safety and health agencies Some of the dynamics at play in regard to drug safety and academia and (non-academic health care facilities) Some of the dynamics at play in regard to drug safety and consumer groups, disease groups and websites Some of the dynamics at play in regard to drug safety with regard to television and the media Some of the dynamics at play in regard to drug safety and lawyers/litigation Chapter 47. Some Real-World Safety Issues and Controversies: FIAU Chapter 48. Some Real World Safety Examples and Issues ¿ Fen-Phen Chapter 49 Some Real World Safety Examples and Issues ¿ Nomifensine Chapter 50. Some Real World Safety Examples and Issues ¿ Vioxx®, Dr. Graham et al
Library of Congress Subject Headings for this publication:
Drugs -- Side effects -- Handbooks, manuals, etc.
Pharmacoepidemiology -- Handbooks, manuals, etc.
Pharmaceutical Preparations -- adverse effects.
Product Surveillance, Postmarketing.