ADE? Or ADR? - Webinar CD/Transcript

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ADE? Or ADR?: Medication Error Case Studies for Successful EU Compliance

Medication error is the 4th most common cause of death in the US. The UK loses $200,000,000 in treating medication errors from hospital funding EVERY year. Regulators are fed up and are making companies take responsibility for these errors. On June 6, the EU added medication errors as a new class of data that must be reported under Good Pharmacovigilance Practices Module VI. Are you prepared?

Recently, this wouldn’t have been your problem to report. Today it is!

Drugmakers, contract manufacturers and physicians are always monitoring, investigating and reporting adverse drug events (ADEs) — only now drugmakers must report medication errors as adverse drug reactions (ADRs). Reporting is required as soon as possible, but no more than 15 calendar days after initial report to a pharmacovigilance center or to the marketing authorization holder.

A top drug development consultant illustrates some of the many danger situations you may face.

These are case studies — actual, not hypothetical. Presenter Dr. Hoss Dowlat, Ph.D. has taken them from his 31+ years involved in drug development in the EU region and North America.

And that’s not all. You’ll discover the regulatory background behind this new EU crackdown, and how to shift your pharmacovigilance focus from products to patients. Check out this agenda:

  • Updates from the May 2013 EMA medication errors workshop
  • 9 factors that increase medication errors in the product lifecycle and special populations
  • What aspects of reporting have changed
  • What medication errors are, and why they weren’t formerly considered ADRs
  • Novel perspectives of EU vs. U.S. perspectives on medication safety
  • Why the EU is adopting the FDA’s risk mitigation tools
  • The EU patient leaflet — an overlooked opportunity for risk minimization?
  • And much more

One medication mixup that leads to hospitalization, disfigurement or death could cost millions upon millions of dollars. It’s not a risk worth taking. If you face EU drug regulation of any kind, for any reason, you owe it to yourself to Order TODAY!

  • Regulatory affairs and compliance professionals
  • Risk management professionals
  • Clinical and drug safety/pharmcovigilance professionals
  • Medical affairs/medical safety professionals
  • Research and development professionals
  • Strategic planning and business development staff
  • Commercial affairs/business development executives
  • Legal staff
  • Executive management

Dr. Hoss Dowlat, Ph.D., VP-Regulatory Affairs, PharmBio Consulting. Dr. Dowlat has more than 31 years of drug development experience in more than 15 therapeutic areas in the European and North American pharmaceutical industries. Pharma and financial clients include more than 50 companies on three continents in search of strategic international regulatory support and due diligence. Dr. Dowlat is British-Canadian, educated in England to B.Sc. and Ph.D. level. He is a recipient of a post-doctoral European Royal Society Fellowship award in organic chemistry.