Assessing the Benefit-Risk Balance in Company Core Data Sheets
The rules of the game have changed.
Do you know the new rules — and how to apply them — for your Company Core Data Sheets?
In July the FDA released significant new guidance on completing the Periodic Benefit-Risk Evaluation Report (PBRER), providing essential new points for you to take into account with filing reports. The FDA guidance:
Answers questions about real-life scenarios your company might encounter, such as multiple, conflicting deadlines among regulatory agencies in different countries.
Explains that fixed-dose combination products can have a cutoff date for data based on either the earliest marketing approval of one of the product’s components or the combination itself.
Details where in the PBRER you can present information on off-label use.
Discusses what information sources you can use in preparing the PBRER.
Includes a must-see table on sharing content between PBRER and DSUR.
Contains vital new information on international “birthdates,” “mature products,” reference information, and exposure data.
Join Graeme Ladds — CEO of PharSafer® — for a discussion on the current guidances and rules including what stayed the same and what changed. If you just rely on your understanding of the guidance that was released four years ago, you’ll be taking a risk and not adhering to the new rules.
This session will help you avoid pitfalls by explaining whether and how the new guidance updates answers these questions and issues:
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 in preparation?
At what point must safety issues be addressed in the CCDS (and when should they not?)
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?
You simply can’t risk filing an inaccurate or incomplete CCDS. Order your copy today.
Pharmacovigilance and drug safety personnel and managers
CCDS writers and reviewers
Medical affairs/medical monitors and physicians
Personnel new to drug safety and pharmacovigilance
Regulatory/legislative affairs personnel
Drug safety scientists/risk management specialists
Marketing authorization holders
Graeme Ladds, CEO, PharSafer® Graeme Ladds, CEO of PharSafer® , has more than 20 years’ experience in the pharma industry. Prior to forming PharSafer® Graeme was as Head of Global Drug Safety for a multi-national pharma company and an EU Qualified Person for Pharmacovigilance (EU QP PV). Graeme has worked as both a pharmacovigilance and medical information manager previously, and has written a book on Multi-National Pharmacovigilance (2006, 2010).