Perfecting Your Company Core Data Sheets

Perfecting Your Company Core Data Sheets - Webinar CD/Transcript

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Perfecting Your Company Core Data Sheets: A Guide for Authoring and Updating the CCDS

Can more than one drug name appear in a CCDS?
Who is the proper party to approve CCDS updates and revisions?
Are YOUR CCDS-writing skills in need of a brush-up?

Composing a Company Core Data Sheet (CCDS) is one of the toughest challenges facing drugmakers today.

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.

The CCDS serves as the basis for prescribing a medication but also for global advertising and promotional activities. In some countries, notably the U.S., promotional claims that do not conform to approved labeling can render the product misbranded.

It’s high time you sharpened your CCDS-writing skills.

Order the webinar CD and transcript set that helps you do just that — in just 90 minutes spent with one of the world’s top experts, consultant Graeme Ladds of PharSafer®.

Mr. Ladds walks you step-by-step through:

  • 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 CCDSs
  • Formatting the CCDS to satisfy international regulatory agencies and end-users
  • How CCDSs can aid in adverse event reporting compliance
  • The approval mechanism for a new and a revised CCDS
  • 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 U.S. and new EU and global rules on safety data reporting
  • Tips for avoiding typical CCDS pitfalls
  • And much more

Is it wiser to start a CCDS early in the drug development process, or wait until initial submissions are in preparation? Mr. Ladds shows you the correct course of action.

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?

Don’t scratch your head. Order today.

  • Pharmacovigilance and drug safety personnel and managers
  • CCDS writers and reviewers
  • Medical affairs/medical monitors and physicians
  • Compliance officers
  • Consultants/service providers
  • Executive management
  • General/corporate counsel
  • Personnel new to drug safety and pharmacovigilance
  • QA/QC personnel
  • Regulatory/legislative affairs personnel
  • Drug safety scientists/risk management specialists
  • Marketing authorization holders
  • Training personnel

Graeme Ladds is CEO of PharSafer®. Previously, he was chief of global drug safety for a multinational pharma company. An EU Qualified Person for Pharmacovigilance (EU QP PV), Mr. Ladds has worked as both a pharmacovigilance and medical information manager. He is the author of A Guide to Global Pharmacovigilance (2006, updated 2010) as well as many articles on pharmacovigilance in peer-reviewed journals. He currently serves as editor on a multinational pharmacovigilance journal. In 2005, Mr. Ladds and a global safety database provider designed a validated global medical information database that links directly to the safety database, providing seamless transfer of ADRs as well as a multifunctional medical services database.