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The only resource of this type worldwide.
Available through amazon.


The table of contents is shown below.
The paperback version has currently approximately 110 pages, US letter size. The book is updated when significant changes to regulations, guidelines and regulatory expectations become known.

Go to amazon.com and search for "Core labeling of medicines" to access the preview of the Kindle version. Under Foreword you will find a summary of new topics added to the book over time.
Note: Owners of the book can obtain from us the text of any substantial new/changes information included in the book. At no cost. Just send an email.


Foreword and important disclaimers
1 Global labeling governance
1.1 The purpose of global labeling governance
1.2 Different approaches 
1.3 Need for rules 
1.4 Reach of governance

2 Company Core Data Sheet and Company Core Safety Information
2.1 Company Core Data Sheet
2.1.1 Definition

2.1.2 CCDS content

2.1.3 Tailoring CCDS content to specific markets

2.1.4 CCDS for inactive products

2.1.5 CCDS scope and structure
2.1.6 Additional CCDS features
2.2 Company Core Safety Information
2.2.1 Definition

2.2.2 Typical strict implementation policy for CCSI

2.2.3 Typical elements of CCSI

2.2.4 Defining CCSI by section?

2.3 CCDS and CCSI as reference information for labeling governance
2.4 CCDS and CCSI as reference information for periodic safety reporting
2.5 Alternatives to CCDS and CCSI

3 Basic business practices for global safety labeling governance
3.1 Implementation fidelity-related expectations
3.1.1 Markup of CCDS content and associated implementation expectations
3.2 Speed-related implementation expectations

4 Target labeling and labeling development
4.1 Definitions
4.1.1 Target labeling
4.1.2 Target product profile

4.1.3 Development labels, Development Core Data Sheet
4.2 Creating and maintaining target labeling
4.2.1 Benefits
4.2.2 Requirements
4.2.3 Content of a target labeling document

5 Adverse reactions - Introduction
5.1 Adverse reactions - The users’ information needs
5.2 Conflicting regulatory definitions of “adverse reaction”
5.3 “Reaction to” or “effect of”

6 Deciding what qualifies to be an “adverse reaction for labeling”

6.1 Two factors to weigh

6.2 Analysis of regulatory definitions
6.2.1 A non-regulatory definition for reference
6.2.2 The definition in the US prescription drug labeling regulation
6.2.3 The “definition” in the European Union’s SmPC guideline
6.2.4 Other regulatory definitions for the purposes of labeling

6.3 Towards a better understanding of the threshold for inclusion
6.3.1 Terminology issues
6.3.2 Visualization of the threshold for inclusion
6.3.3 Visualization of threshold criteria in regulatory definitions for labeling
6.3.4 Comparison with the threshold criteria proposed by the CIOMS III/V
6.3.5 Still sitting on the fence?
6.3.6 Comparison with the ICH threshold criteria for potential and identified risks
6.3.7 Unsuitable definitions from the universe of safety reporting

6.4 How to determine the level of confidence and relevance
6.4.1 Determining the level of confidence in a causal association
6.4.2 Determining the relevance of a potential adverse effect
6.4.3 Judgment and bias

6.5 Class reactions

6.6 Term grouping and more
6.6.1 Using MedDRA terms
6.6.2 Diagnosing
6.6.3 Diagnostic grouping
6.6.4 Lexical grouping
6.6.5 Term selection for headings
6.6.6 Need for early planning

6.7 Illustrating the likelihood of adverse effects
6.7.1 Some general principles
6.7.2 Some standard approaches
6.7.3 Assessing worldwide harmony
6.7.4 What to do in CCDS and CCSI?

6.8 Some frequently asked question
6.8.1 Can I omit less important adverse reactions?
6.8.2 Only adverse effects to a product or all adverse effects to using a product?
6.8.3 Should I have separate adverse reaction tables/lists for different indications/uses?

7 Interactions
7.1 Definitions and some general principles
7.1.1 Pharmacokinetic and pharmacodynamic interactions
7.1.2 Clinically significant (clinically relevant) interactions
7.1.3 Desirable and undesirable interactions

7.2 Criteria for including clinically significant undesirable interactions in labeling
7.2.1 Basic approach
7.3 Triviality of pharmacodynamic interactions
7.4 To label interactions in both directions?
7.5 Talking about classes and listing examples
7.6 Which label section?
7.7 Precautionary measures and other recommendations

8 Interference with laboratory tests and other diagnostic tests

9 Deleting adverse effects from labeling

10 When to elevate a risk to the warnings and precautions level
10.1 The nature of a Warnings & Precautions section
10.2 Elevating information to Warnings & Precautions in a CCDS
10.2.1 Level of confidence in a causal association
10.2.2 Relevance

10.3 Relationship to the ICH concept “important risk”
10.4 Boxed warnings and CCDS or CCSI
10.5 Warnings text

11 Delineating the target population for use and describing other conditions of use
11.1 Some definitions
11.1.1 Indication, target condition of use and intent of use
11.1.2 Non-indication
11.1.3 Absolute contraindication
11.1.4 Relative contraindication
11.1.5 Prohibited/discouraged action
11.1.6 Target population of use

11.2 Comparison with clinical trial inclusion and exclusion criteria
11.3 General principles
11.3.1 Explicitness and strictness of advice
11.3.2 Using positive or negative language

11.4 Elements of the description of the target population and their location in labeling
11.4.1 Strict descriptors
11.4.2 Soft descriptors of the target population
11.4.3 Using strict and soft descriptors as a tool to guide user decisions

11.5 No silence topics
11.6 Other conditions of use and burden of use
11.7 FDA’s “limitations of use”
11.7.1 Type 1 LoUs: Explaining the reason for the limits of an indication
11.7.2 Type 2 LoUs: Discouraged uses worth mentioning in the Indications and Usage section
11.7.3 Type 3 LoUs: Other conditions to be mentioned in the Indications and Usage section
11.7.4 Additional aspects
11.7.5 Implications for CCDS and CCSI

12 When and how to contraindicate
12.1 Definitions
12.2 General principles
12.3 US FDA’s guidance on when to contraindicate

13 Providing the reason for advice

14 Glossary
15 References