Company Core Data Sheets and Benefit-Risk Evaluations: A Drugmaker’s Guide to Postmarket Safety Reporting
Your company core data sheets (CCDS) form the basis of postmarket safety reports that you are required to submit to regulators. CCDS must be constantly updated throughout any drug’s lifecycle to include the most current and complete information possible.
CCDS and Periodic Benefit-Risk Evaluation Reports (PBRER) go hand in hand during the postmarket phase of a drug’s lifecycle. Without a complete and accurate CCDS, you have no framework for evaluating adverse events and safety signals when compiling your reports for regulatory authorities.
Company Core Data Sheets and Benefit-Risk Evaluations: A Drugmaker’s Guide to Postmarket Safety Reporting walks you through both phases, explaining first what safety information should be included in a CCDS — approved indications ... dosing requirements ... methods of administration ... concerns of special patient populations ... packaging and storage requirements and limitations ... incompatibilities and pharmacological properties — and how to use that information when preparing postmarket safety reports to submit to regulators.
Key Management Report Takeaways:
- The origin and purpose of the CCDS
- How to create a drug’s initial CCDS and how to update it as the drug evolves
- What to include in the company core safety information (CCSI) part of a CCDS
- How frequently safety reports must be submitted
- How and why to seek a PBRER waiver
- What appendix documents to include in a PBRER
The report provides a comprehensive explanation of FDA, EMA and ICH requirements for CCDS files and PBRERs, including key guidances issued by each agency. The report provides a 24-part guide for CCDS content and a 20-point outline for PBRERs.
Know the rules — and how to apply them — for your CCDS and PBRERs with the Company Core Data Sheets and Benefit-Risk Evaluations management report. Order your copy today.
Who Will Benefit
- Quality control unit
- Pharmacovigilance/postmarket surveillance unit
- Regulatory affairs staff
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