FDAnews Announces — Assessing the Benefit-Risk Balance in Company Core Data Sheets Webinar, Dec. 14, 2016

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In July the FDA released significant new guidance on completing the Periodic Benefit-Risk Evaluation Report (PBRER), providing essential new points for manufacturers to take into account with filing reports. Join Graeme Ladds, CEO of PharSafer®, on Dec. 14 for a discussion on the current guidances and rules including what stayed the same and what changed.

Assessing the Benefit-Risk Balance in Company Core Data Sheets
**An FDAnews Webinar**
Dec. 14, 2016 — 11:00 a.m. – 12:30 p.m. ET
http://www.fdanews.com/benefitriskcompanycoredatasheets    

How frequently should a CCDS be updated?

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?

What are the new rules for Company Core Data Sheets and how should they be applied?

In July the FDA released significant new guidance on completing the Periodic Benefit-Risk Evaluation Report (PBRER), providing essential new points for manufacturers to take into account with filing reports. The FDA guidance:

  • Answers questions about real-life scenarios companies 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 manufacturers can present information on off-label use.
  • Discusses what information sources that can be used 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® —on Dec. 14 for a discussion on the current guidances and rules including what stayed the same and what changed.

This webinar will help manufacturers avoid pitfalls by explaining:

  • Best practices for updating and maintaining CCDSs
  • What safety data should, and should not, be included in a CCDS
  • Which departments and committees should be responsible for editing CCDSs
  • How to manage these teams with sometimes opposite goals
  • SOP language that can help improve CCDS writing and editing efforts
  • How CCDSs can aid in adverse event reporting compliance
  • Clarification of US and new EU and global rules on safety data reporting
  • Essential elements all CCDS’s should have
  • Formatting the CCDS to satisfy international regulatory agencies and end-users
  • The approval mechanism for a new and a revised CCDS
  • Tips for avoiding typical CCDS pitfalls

Manufacturers simply can’t risk filing an inaccurate or incomplete CCDS. Register for the Assessing the Benefit-Risk Balance in Company Core Data Sheets webinar today.

Meet the Presenter:
Graeme Ladds, CEO, PharSafer®

Graeme Ladds 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).

Who Will Benefit:

  • 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

Webinar Details:
Assessing the Benefit-Risk Balance in Company Core Data Sheets
**An FDAnews Webinar**
Dec. 14, 2016 — 11:00 a.m. – 12:30 p.m. ET
http://www.fdanews.com/benefitriskcompanycoredatasheets        

Tuition:
$287 per site

Easy Ways to Register:
Online: http://www.fdanews.com/benefitriskcompanycoredatasheets                            
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
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