ann rockley — managing the complexities of the core data sheet (cds)

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www.rockley.com ©2015 The Rockley Group, Inc.

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Managing the Complexities

of the Core Data Sheet

Ann Rockley, President

The Rockley Group

@arockley


The Rockley Group

• More than 15 years’ experience in Healthcare

• Clinical

• Labeling

• Promotional

• Industry experts

• Structured content strategy

• Content reuse

• Structured content management systems

• Content globalization strategy

• Multichannel delivery

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Rockley Customers

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Ann Rockley

• Known as the “mother of content

strategy”

• Forefront of content strategy, reuse,

structured content management,

multichannel delivery (print, Web,

eBook, mobile)

• Passionately committed to defining

and sharing industry best practices

• Master of Information Science

• Fellow of the Society for Technical

Communication

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Disclaimer

• This presentation is not a recommendation for content for

your core data sheet or associated labeling, only your

regulatory group and other authorized personnel can

specifically identify your requirements.

• This presentation is designed to provide an understanding

of how you can more effectively create and manage your

core data sheet

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What is a core data sheet?

A document prepared by the applicant containing, in

addition to safety information, material relating to

indications, dosing, pharmacology, and other information

concerning the drug substance (biological product for

proposed Sec. 600.80(a)). The only purpose of this

document is to provide the company core safety information

(CCSI) for periodic safety update reports (PSUR), interim

periodic safety reports (IPSR), and certain individual case

safety reports – semiannual submissions (i.e., if PSURs are

submitted for the product).

[Technical Requirements for Registration of Pharmaceuticals for Human Use, the ICH E2C Rev. 1]

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• A primary reference document that contains:

• Indications

• Dosing requirements

• Method(s) of administration

• Patient population concerns

• Packaging and storage

• Incompatibilities

• Pharmacological properties

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“Your core data should represent the up-to-minute

information for a particular product as it concerns

indications, pharmacology and safety information.”

Perfecting Your Company Core Data Sheets http://bit.ly/1EINLOG

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• The core source for your labeling

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CDS as source

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USPI

• United States Package Insert (Prescribing Information)

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USPI structure

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SmPC

• Summary of Product Characteristics (SmPC)

• Also referred to as SPC

• Used by healthcare professionals

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SmPC structure

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PIL

• Patient Information Leaflet (PIL)

• Also called:

• Package Leaflet (PL)

• Package Insert (PI)

• Patient friendly version of the Summary of Product

Characteristics

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Medication Guide

• Paper-based guide for patients

• Patient friendly version of the USPI

• Required when FDA determines:

• Certain information is necessary to prevent

adverse effects

• Patient should be informed about a serious side effect

• Patient adherence to directions are essential to

effectiveness

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What should go into your CDS?

• FDA recommends:

• Indications

• Dosing requirements

• Method(s) of administration

• Patient population concerns

• Packaging and storage

• Incompatibilities

• Pharmacological properties

• Leaves a lot to the organization to determine exactly what

goes into the CDS

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What should go into your CDS?

• Content needed to provide an efficient approach to

evaluating safety

• Generate:

• USPI

• SmPC

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Compare USPI and SmPC sections

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• Some sections may map directly to each other

• Some sections may be buried (e.g., don’t have a separate

header/title) in another

• Some sections may not be present in both

Compare USPI and SmPC sections

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Compare content

• Compare content in common sections

• Probably find that the content is similar, but expressed

differently

• Could the content be identical regardless of Health

Authority?

• If there is a very good reason for the content to be similar

not identical, can part of it be the same?

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Creating the CDS

• Develop a consistent structure for the CDS

• Identify which sections are required and which are optional

• Identify which sections may be unique to one Health

Authority versus another

• Work towards identical use/reuse of content in each label

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Components not documents

• Each section in the CDS becomes a separate component

• Order doesn’t matter. Order, and associated numbering is

applied as the content is assembled and published

• Content is reused, not copy and pasted

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Reuse

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Structured content management system

©Nathan Sawaya http://www.fastcocreate.com/1682144/making-lego-into-art-

nathan-sawayas-impossible-brick-sculptures#1

• Manages content at a granular

(component) level of content, rather

than at the page or document level.

• Each component represents a

single topic, concept, or asset (such

as an image or table).

• Components are assembled into

multiple content assemblies

(information products) such as a

CDS, USPI, SmPC.

• Each component has its own

lifecycle (owner, version, approval,

use) and can be tracked individually

or as part of an assembly.

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Control

• Elimination of manual processes

• Content is managed in source, not output

• Change in CDS results in notification of change

• Content is tracked at every point in the lifecycle

• Strict attention to version control, permission for change

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Auto-population

• You could automatically generate the content for the USPI

or SmPC

• Review and approval would of course be necessary, but

no more copy/paste or subjective rewriting the content

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Identical vs. derivative

• Identically reuse content where possible

• While identical content in all outputs is desirable it isn’t always possible due to Health Authority feedback

• Derivatively reuse content when necessary

• Content is reused from the common CDS then a variation on the source is created (derivative)

• A relationship exists between source and derivative, when the source changes the creator/owner of the derivative is notified of the change

• The creator/owner can choose to incorporate the changes or not

• Complete audit trail of changes and derivatives

• Authors can only reuse source not derivatives unless the derivative is promoted to alternate source (e.g., common regions)

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Collaboration

• Authoring is collaborative, many authors can put content

into the CDS and see each others’ input

• Requests for change can be identified in the regions and

potentially incorporated globally

• Review is collaborative, reviewers can review

simultaneously and see and comment on others’ review

comments

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Resistance to change

• Perceived differences in requirements

• Everyone starts with the same then if required,

derivative content can be created

• Not being created by the region

• If input and creation of the CDS is collaborative, these

issues diminish

• Loss of control

• Control is collaborative

• Reduced workload due to reuse enables region to

focus on real value-add for their region, not mechanical

tasks

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Overcoming resistance

• Educate

• Welcome participation and input

• Expect problems, deal with them and move on

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Beyond the basics

• Derivative versions of content can be created for patients

(Medication Guide, PIL). Change in core can automatically

identify changes required elsewhere

• Reusable content (e.g., indications, storage and handling)

can be automatically reused into:

• Packaging

• Promotional (sell sheets, reimbursement details, web

site, speaker decks)

• Learning (in-service training)

• Wherever the same content appears it can be reused from

the CDS

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Summary

• Don’t handcraft your core data sheet. Create and manage

it intelligently:

• Structured

• Modular (components not documents)

• Reusable

• Controlled

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You can watch this webinar with Ann Rockley on the BrightTalk Channel at:

https://www.brighttalk.com/webcast/9273/146091

ann rockley — managing the complexities of the core data sheet (cds)

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