U.S. and EU Individual Case Safety Reports Roadmap to Success: Tips, Strategies for Global Implementation of ICH E2B(R3)

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1 - 9999
Regulators worldwide have grown weary of safety concerns not reaching them fast enough.  The FDA and EU are tackling this problem by implementing a new international data standard and reporting system — HL7 ICSR.

In the U.S., this standard for drugs and biologics will be finalized soon, sometime in mid-2011.

What does this mean for you?

Individual Case Safety Reports and the ICH E2B(R3) Implementation Guide is your next big challenge.  Pharmacovigilance data management will never be the same.

This webinar, led by Graeme Ladds, an accomplished pharmacovigilance expert and author, will lead you step-by-step through the jungle of U.S. and EU implementation differences, data conversions, common errors and quality/accuracy cross-checks.

Register today to not only get insight on the ICRS standards, but a roadmap to best practice implementation.

In 90 fast-paced minutes, Graeme Ladds will teach you:

  • Case processing differences in the U.S. vs. EU
  • Key differences between the ICSR draft and the finalized standard
  • Main principles of the ICSR message based on HL7 and ISO standards
  • How to plan for the implementation of the HL7 standard
  • How to avoid common errors in safety reporting to the EMA
  • How to resource and process compliance data
  • Differences in electronic reporting when dealing with serious vs. nonserious vs. consumer-expected vs. unexpected compliance and inspections
  • How to focus on quality and accuracy of ICSR reports in each situation

U.S. and EU Individual Case Safety Reports: Roadmap to Success is convenient to attend. All that’s required is that you be in front of a screen at the appointed time, whether you work at the office or telecommute from your office at home.

Of course, Mr. Ladds will be on hand to answer all of your questions. Simply submit them via email, and you’ll have answers by the time the session ends.

Key people throughout your company will benefit from taking part in this event. Best of all, everyone can do so at a cost that won’t break your budget. You pay one single low registration fee per facility, regardless of how many participate. So spread the word.

A global drug and biologics industry means global customers ... global problems ... and global regulation. It’s a new world — one you must understand to survive and prosper. This webinar offers the tools you need. Start here. Start now.

This conference is a must for every drug and biologics company that operates in the global marketplace. It’s especially appropriate for –

  • Pharmacovigilance staff
  • Medicines regulatory authorities
  • Pharmacovigilance software companies
  • Clinical trial sponsors

Graeme Ladds, CEO of PharSafer Associates Ltd., has more than 20 years experience in the pharma industry. Before forming PharSafer, Mr. Laddsheaded global drug safety for a multinational pharma company and was an EU Qualified Person for Pharmacovigilance (EU QP PV). He is author of a book and many peer-reviewed articles on multinational pharmacovigilance, and currently serves as an editor of Pharmacovigilance Journal.

Register now!

Date: Aug. 22 – Sept. 9, 2011
Location: Your office or conference room (no need to travel!)
Time: Anytime

Gather your team for maximum benefit! Your investment is for one dial-in.

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