Safety Labeling
In Depth Review of Important Aspects
Overview
- 2-Day seminar
- For pharmaceutical company employees; admission of other attendees only on invitation by Pharmiceutics LLC
Target Audience
- Labeling/regulatory professionals
- Labeling auditors and other QA professionals
- Pharmacovigilance professionals
- Clinical/medical professionals
- Law department members
It is recommended - but not required - to first attend our seminar “Company Core Data Sheets and Core Safety Information” or “US Prescribing Information with Highlights & US Safety Labeling” which present the general must-knows from a global, EU and US labeling perspective, respectively. However, the curriculum of this seminar makes it also worthwhile to attend as stand-alone seminar, even before attending one of the other seminars. The number of participants in this seminar will be limited.
Brief Program Outline
The following outline is a sample only and the actual seminar may differ.
Day 1
Brief Recap of Important Definitions and Rules for Safety Labeling Decision Making
- Definition of “adverse reaction for the purposes of labeling”; Review of definitions used in the field of pharmacovigilance
- Definition of “clinically relevant/significant interaction”
- Threshold criteria for including adverse reactions in labeling – CIOMS guidelines, US, EU and other labeling regulations and guidelines
- How the relevance (seriousness etc.) of potential adverse reactions influences when they are added
- Definition: “Precaution”, “Warning”, “Contraindication”
- When to elevate risks to “Warnings and Precautions”
- When to contraindicate
- When and how to provide advice to consider avoidance
- Principles of describing the probability (frequency) of adverse reactions
- Important market-to-market differences in the application of basic labeling principles
- The effect of subjectivity on decision making
From Clinical Trial Adverse Events to the Presentation of Risks in Labeling
- Understanding the main differences between decisions to add adverse reactions based on clinical study data and on spontaneous postmarketing reports
- Are clinical study adverse reactions of “superior quality”?
- Background noise and the role of individual-case causality assessment by investigators
- The effect of term-grouping and definitions
- Which data to consider when deciding if an observed event is an adverse reaction for the purposes of labeling
- Brief review of FDA’s “Safety Reviewer Guidance”
- How to decide if an observed difference in rate between drug and comparator is “real”
- Group exercise and discussion of results: From lists of events to reactions in labeling
Allergic Reactions, Other Hypersensitivity Reactions, and Infusion Reactions – Addressing Immunogenicity
- Definition of “hypersensitivity”, “hypersensitivity reactions”, “allergic reactions”, “anaphylactic reactions”, “anaphylactoid reactions” and related terms.
- How to deal with the differences in the understanding of some terms by healthcare professionals
- Review of related terms in MedDRA
- Various types of infusion reactions. How to describe them and provide meaningful advice
- Mechanisms and categorization of allergic and immune reactions
- Factors determining the immunogenicity of medicines
- How to describe immunogenicity in labeling in a way that reflects the level of concern
Day 2
Controlling Terminology in Labeling – Dealing with MedDRA’s Granularity, Hierarchy and Axiality
- Review of MedDRA from a labeling perspective
- Review of key points of the MSSO's "MedDRA and Product Labeling: 'Best Practices' Recommendations"
- Principles of good term grouping – To which extent can we use MedDRA’s “built-in” group terms
- Understanding MedDRAs axiality - allocating an adverse reaction to an appropriate SOC
- Risk communication issues associated with changeover of labeled terms from other terminologies to MedDRA
- Group exercise and discussion of results: Rational term grouping
- Group exercise and discussion of results: Selecting the best SOC
Dealing with Event Cascades – Addressing the Potential Severity of Adverse Reactions
- The difference between expectedness, labeledness, listedness and communicatedness
- Understanding regulatory event reporting rules and how they do/don’t affect labeling
- When to add to labeling information about more serious or more specific outcomes
- The need to “diagnose” the adverse phenomena associated with the use of a product
- When facing a cascade of events/reactions and associated symptoms – How to decide what is the adverse reaction for the ADR table, and what to describe elsewhere or not at all
- Group exercise and discussion of results: When and how to inform about the potential seriousness of adverse reactions
Selecting Adverse Reaction Frequency Categories for EU Labeling – Use of rates in US labeling
- Understanding terminology used in labeling guidelines: Rate, frequency, probability, incidence, crude incidence rate etc.
- Understanding the “Rule of Three”
- Dealing with “background noise”
- For US labeling, how to decide where to cut off the table of common adverse reactions
- In the US and EU, are the “most common adverse reactions” really the most common adverse reactions?
- How to correctly describe the data in a US Common Adverse Reactions table
- Group exercise and discussion of results: Using the rule of three for determining the probability of adverse reactions that were not observed in clinical studies
- Group exercise and discussion of results: How to decide, for US labeling, where to cut off the table of common adverse reactions
Labeling News – A regulatory update on new developments and trends in safety labeling
- Developments and trends that will affect the way we write safety labeling
- What to look out for?