US Prescribing Information
With Highlights & US Safety Labeling
Overview
- 2-Day seminar
- For pharmaceutical company employees; admission of other attendees only on invitation by Pharmiceutics LLC
Target Audience
- Labeling/regulatory professionals
- Pharmacovigilance professionals
- Clinical/medical professionals
- Law department members
- For those new to US labeling and for experienced professionals who seek discussion with peers and the instructor about particular challenges and newest trends
Brief Program Outline
The following outline is a sample only and the actual seminar may differ.
This seminar covers
- the practical aspects of writing US Prescribing Information with Highlights, be it from scratch or based on old-format labels
- New and reinforced expectations regarding labeling content and, in particular, safety content
The structure of the seminar follows the section structure of Full Prescribing Information (FPI).
Per section or group of sections, formal and content aspects are reviewed, with particular attention to common problems in generating and presenting the required set of information. This includes a detailed discussion of concepts and criteria for defining and presenting safety information (see below).
In addition, issues related to section placement and ranking of information within sections are discussed.
Safety Labeling:
The seminar's coverage of clinical safety content addresses FDA's Physician Labeling Rule and safety labeling guidance documents (published in 2006 and before) as a single, coherent body of concepts and criteria for defining the risk profile of a product - for the purposes labeling and for risk communication in general.
The seminar has been designed to further enhance the attendees' understanding of FDA's requirements and guidelines. It will enable attendees to interpret FDA's expectations critically when determining, for the purpose of labeling, the list of adverse reactions and interactions, and when designing the set of contraindications, warnings and precautions.
The seminar includes discussion of important differences between international safety labeling traditions. A good understanding of US and international requirements, of the overall conceptual framework and of still uncharted areas are essential for determining the acceptability of differences between US safety labeling content, Company Core Safety Information and safety labeling in other regions (eg, EU and Japan).
Restructuring:
One of the key objectives of this seminar is to demonstrate a structured approach to revising and reformatting old labels and provide participants with practical tips and ideas for useful tools (templates, checklists etc.).
Note:
The seminar is open to pharmaceutical company employees only. Other registrations cannot be accepted.
The seminar binder is not available for separate purchase. No electronic copy of the seminar binder is available.
Agenda
The agenda might change to reflect newest developments in safety labeling.
Day 1
7:30 Registration and Continental Breakfast
8:00 Introduction
8:30 Content and Format of the Adverse Reactions Section
Identifying "adverse reactions for the purposes of labeling" – threshold and other criteria
Topics include:
Clarified definition of "adverse reactions for the purposes of labeling"
Detailed review and discussion of "causality threshold criteria" in FDA's 2006 Adverse Reactions section guidance and relevant parts of FDA's 2005 safety reviewer guidance
Comparison with the rules for populating the adverse reactions section in other markets (e.g. EU) and with CIOMS recommendations
10:00 Break
10:15 Content and Format of the Adverse Reactions Section (continued)
Adverse reaction rates, tables, lists and other features of the Adverse Reaction section
Topics include:
Section substructure and rules for presenting adverse reactions and rates
Where to cut off the table of common adverse reactions
Adverse reaction frequency illustrated by rates of adverse events - Resulting "terminology issues"
Complete walk-through FDA's Adverse reactions Section guidance and review of example labels
Part III - Conversion from old to new format and content: Points to consider
Topics include:
Analyzing an Adverse Reactions section and its history before acting - What can be changed, what should not be changed
How to deal new clinical study safety data - Adding or not adding new tables or lists
Regulatory considerations; impact of changes on international labeling
12:15 Lunch
1:00 Indications and Usage - Contraindications
Describing the target population for medication use in positive and negative terms. Analysis of 21 CFR 201.57 and draft guidance
Topics include:
How labeling defines the target population for use; which criteria are included in Indications and Usage, which criteria in Contraindications
FDA's draft clarification of the definition of contraindication ("Known hazards and not theoretical possibilities")
FDA's draft threshold criteria for risks that can support a contraindication
Including or not including hypersensitivity contraindications - Applying FDA's draft guidelines; international aspects
Describing the risk behind contraindications
3:00 Break
3:15 Warnings and Precautions - Use in Specific Populations
Criteria for elevating information to the level of W&P. Criteria for placing information in UiSP
Topics include:
FDA's draft threshold criteria for discussing risks in Warnings and Precautions
Candidate populations for inclusion UiSP - Review of example labels
Section substructure and semantic units
Topics include:
Structuring the initial part of Warnings and Precautions based on "risks"
Writing per-risk semantic units
Dealing with the ubiquitousness of precautionary advice
Conversion from old to new format and content: Points to consider
Topics include:
What to move from Warnings and Precautions to UiSP
Sorting warnings based on relative public health significance of the adverse reactions
5:15 End of Day 1
Day 2
8:00 Continental Breakfast
8:15 Interactions - Interference with Laboratory Tests
Criteria for including interactions in the Interactions section, and for elevating interaction information to W&P. Which information to cover in Clinical Pharmacology
Topics include:
Threshold criteria for including interactions in Interactions
Threshold criteria for including interactions in Warnings and Precautions
Conversion from old to new format and content: Points to consider
Topics include:
What to move from Clinical Pharmacology to Interactions
9:15 Clinical Pharmacology – Clinical Studies
Suggested content and structure; review of FDA's guidance on the content and format of the Clinical Studies section
Topics include:
What to include in Mechanism of Action, what in Pharmacodynamics
Detailed review of FDA's Clinical Studies section guidance
Where to describe microbiology data
Conversion from old to new format and content: Points to consider
Topics include:
Dealing with existing dosage recommendations in Clinical Pharmacology
10:30 Break
11:00 Dosage and Administration - Others Sections
Proposed content and presentation of information
Topics include:
Review of FDA's draft D&A section guidance
FDA's draft criteria for defining a pharmacological class
Conversion from old to new format and content: Points to consider
Topics include:
Dosage Forms and Strengths and How Supplied section - Differences and overlaps
12:15 Lunch
1:00 Highlights
Identifying candidates for inclusion in Highlights. Creating informative bullet points
Topics include:
Review of 21 CFR 201.57 and approved Highlights sections
Screening FPI for Highlights-worthy messages
Abbreviating without loosing the message
Formal and formatting aspects. Determining the length of Highlights
Topics include:
Understanding the "micro-anatomy" of the Highlights section format
Using FDA's "sample tool" for determining the length of the Highlights section
Exercise
Creating informative bullet points
3:00 Break
3:15 General Issues - Presenting Proposed Changes
Repetition of information and cross references. Formatting traps, opportunities for mistakes. QC strategy
Topics include:
Creating a balanced cascade of information and helpful cross-references
Section title style hierarchy
Appending PPIs
Common structuring and formatting problems: FDA's and the instructor's observations
Creating a QC checklist based on 21 CFR 201.56 and 57, FDA's guidances and other sources
How to transparently present proposed changes made during conversion from old to new format and allow for easy QC
Topics include:
An economical restructuring workflow
Presenting and explaining changes to company-internal reviewers
Transparent presentation and documentation for FDA
4:45 End of Seminar