Perfecting Your Company Core Data Sheets A Guide for Authoring and Updating the CCDS - 2014
Composing a Company Core Data Sheet (CCDS) is one of the toughest challenges facing drugmakers today. Are YOUR CCDS-writing skills in need of a brush-up?
Here’s the help you need.
The CCDS is the prime reference document for every one of your drugs or biologics — the central document regulators and resellers rely on to label and manage the drug’s use.
Approved indications ... dosing requirements ... methods of administration ... concerns of special patient populations ... packaging and storage requirements and limitations ... incompatibilities and pharmacological properties — all must be in the CCDS, plus safety information.
And there’s more. You must update each CCDS to reflect the drug’s evolution. New indications, dosing changes, changes in handling procedures, safety concerns — all those factors and more must be added in on a regular basis.
What’s the best way to correctly handle these essential documents? Make sure you’re up to speed with the authoritative report from FDAnews: Perfecting Your Company Core Data Sheets: A Guide for Authoring and Updating the CCDS - 2014.
In this newly updated 2014 edition there is an expanded section on company core safety information (CCSI), including:
Practical strategies for developing complete company core safety information
A roadmap for conducting safety review meetings and determining what to include and exclude in the CCSI
How to comply with the new requirements of the FDA’s investigational new drug safety reporting rules
How and when to include postmarketing and clinical trial data in ADR tables
In addition, this guide spells out how to draft and maintain a CCDS for each of your products — a start-to-finish explanation that includes:
Essential elements every CCDS must have
Updating and maintaining CCDSs — what’s working and what’s not
What safety data should and should not be included in your CCDS
Formatting the CCDS to satisfy international regulatory agencies and end-users
The approval mechanism for a new and a revised CCDS
How CCDSs can aid in adverse event reporting compliance
Which departments and committees should be responsible for editing CCDSs
How to manage these teams and their sometimes opposing goals
SOP language that can improve CCDS writing and editing efforts
Clarification of US and new EU and global rules on safety data reporting
Tips for avoiding typical CCDS pitfalls
And much more
Perfecting Your Company Core Data Sheets answers your toughest questions:
How frequently should a CCDS be updated?
Is it wiser to start a CCDS early in the drug development process or wait until initial submissions are being prepared?
At what point must safety issues be addressed in the CCDS (and when should they not be?)
Can more than one drug name appear in a CCDS?
If only one country's regulators require a labeling change, must the CCDS reflect that?
Where in the CCDS should you report disposal considerations and other safe handling requirements?
Who is the proper individual to approve updates and revisions to the CCDS?
With Perfecting Your Company Core Data Sheets: A Guide for Authoring and Updating the CCDS - 2014, you'll have the tools to create and maintain a CCDS that will withstand regulatory scrutiny, and you’ll avoid the unnecessary extra work that comes from assuming what’s the best way to write them.
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