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Volume 2, Issue 2 UPDATE-ERR™ Spring 2009

President's Messaage

Spring 2009

Medication safety continues to be a hot topic at most pharmaceutical companies as well as at the FDA. Recent developments related to Risk Evaluation and Mitigation Strategies (REMS), as well as other safety-related issues in the news such as the decision by FDA, and then the rapid reversal of its decision, to remove concentrated morphine solution from the market has lead to some exciting events in the last few months.
To all our colleagues in the trademark world, we look forward to seeing you in Seattle next month at the INTA meeting. Please visit us at our booth (number 120) and see the new look for Med-ERRS.

Please feel free to pass the newsletter on to your colleagues.

Warm regards,

Susan

Articles of Interest

EMEA Guideline on the readability of the labeling and package leaflet of medicinal products for human use.
http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-2/c/2009_01_12_readability_guideline_final.pdf

The Food and Drug Administration (FDA) is announcing the availability of the source code and supporting technical documentation for the Phonetic Orthographic Computer Analysis (POCA) software program.
http://www.fda.gov/OHRMS/DOCKETS/98fr/E9-3170.pdf

Ask an Expert

If you have a question related to one of Med-ERRS services or have an industry-specific inquiry, please Click Here and one of our experts will get back to you with an answer.

 

(INTA)-Sights in Seattle

Recommended places to visit in Seattle, Washington while attending INTA.

Looking for a "get away"? A ferry ride from the Seattle waterfront to Bainbridge Island is highly recommended.
http://www.seattletravel.com/bainbridge-island-seattle.html

For those with an architectural/historical yen, there is the Seattle Underground Tour-not for the claustrophobic!
http://www.undergroundtour.com/index.html

May 21-June 14 Film Festival.
http://events.frommers.com/sisp/index.htm?fx=event&event_id=31126

8 Terrific Day Trips.
http://www.visitseattle.org/visitors/itineraries/daytrips.asp

Parks to Visit.
http://www.visitseattle.org/visitors/itineraries/parks.asp

Must see and Do.
http://www.visitseattle.org/visitors/explore/mustdo.asp

ISMP Information

Institute for Safe Medication Practices (ISMP) is pleased and excited to announce the launch of CoConsumer Med Safety Websitensumer Med Safety (www.consumermedsafety.org), the first and only website on the internet exclusively designed to bring the message of medication safety to the consumer market.
ISMP steadfastly believes that consumers can and want to play a key role in their safety when receiving and taking medications. This unique, interactive website will offer consumers a reliable source of information, rich with stories and advice that will clearly impact consumer medication safety. 
Inattentional Blindness: What Captures Your Attention?
http://www.ismp.org/Newsletters/acutecare/articles/20090226.asp

FDA to Meet with Drug Companies about REMS for Certain Opioid Drugs
http://www.fda.gov/cder/drug/infopage/opioids/default.htm

FDA Adopts Interim Plan to Avoid Shortage of Medically Necessary Opioids
http://www.fda.gov/bbs/topics/NEWS/2009/NEW01994.html

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Med-ERRS Services

****** Please contact us for our 2009 pricing******

  • Trademark Evaluation: Med-ERRS has developed a service for evaluating the safety of trademarks called the ERRS MODELTM, which incorporates various techniques recommended by the FDA to evaluate the safety of trademarks.
  • SCREEN-ERR: Helps companies evaluate multiple pharmaceutical trademark candidates at an early stage in the trademark development process.
  • Package and Label Evaluation : Helps clients create packaging and labels that are easy to understand and consistent with the most current FDA and world wide regulatory authorities.
  • Safety Consulting : Provides consultative services which are related to a variety of medication safety-related issues. 
  • EVALUATE-ERR: Conducts an in-depth analysis of error reports using data from the client as well as other medication error databases.


Med-ERRS

200 Lakeside Dr, Suite 200
Horsham, PA 19044
215-947-8306