SEMINAR INFORMATION

US Prescribing Information with Highlights & US Safety Labeling

Understanding – Writing – Reformatting
Safety and Other Sections

Next public seminar: September 8-9, 2008
Radisson Plaza-Warwick, Philadelphia, PA

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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

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