FDAnews Announces — Choosing the Right Drug Name: Increase Your Chances for Approval by FDA and Health Canada Webinar, Jan. 20, 2016

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FDAnews has teamed with drug-naming expert Dr. Susan Proulx to present a 90-minute webinar that will look closely at the FDA’s draft guidance and Canada’s guidance “Review of Drug Brand Names”. Dr. Proulx will provide ideas on how to win approval for the suggested drug name.

Choosing the Right Drug Name:
Increase Your Chances for Approval by FDA and Health Canada
Jan. 20, 2016 — 1:30 p.m. – 3:00 p.m. EST
http://www.fdanews.com/rightdrugname

The FDA rejects 40% of the drug names presented to it each year.

Not surprisingly, the drug industry has criticized the agency about its name approval process.

So, in May 2014, the FDA released a draft guidance that covers the selection and approval process for proposed names of both prescription and nonprescription human drugs and biologics. In the guidance, the FDA describes its own review processes in detail and lays out 4 steps to follow in choosing a drug name. And, Health Canada’s guidance “Review of Drug Brand Names” came into force last July.

FDAnews has teamed with drug-naming expert Dr. Susan Proulx to present a 90-minute webinar that will look closely at both guidances. Dr. Proulx will provide ideas on how to win approval for a suggested drug name.

BONUS HANDOUT: Attendees will receive their own copy of a chart that compares drug name approval regulations in the US and Canada.

And attendees will learn more about the following:

  •     How the new guidance will affect drug trademark development (in time, money and the differences from country to country on processing a global mark)
  •     Pros and cons of relying on computerized searching to identify similarity in proposed names
  •     Using simulation testing — how to conduct testing similar to what the FDA will eventually do on a chosen drug name
  •     The need for expert analysis before deciding what trademark to choose

Choosing the Right Drug Name: Increase Your Chances for Approval by FDA and Health Canada is sure to be a presentation not to miss.

Meet the Presenter:
Over the course of her career in Medication Safety, Dr. Susan Proulx has become an expert in all aspects of product-related safety issues. In addition to being a leader in the industry in preventing medication errors due to trademark confusion, she also has overseen numerous projects related to improvement of packaging and labels to increase clarity and ease of reading. In recent years, Dr. Proulx has lent her medication safety expertise to the field of Human Factors Engineering, collaborating on label safety and drug-device usability issues. Some of these projects have led to patents and publications.

Who Will Benefit:

  •     Strategic planning and business development staff
  •     Marketing, sales and advertising personnel
  •     Compliance officers
  •     Risk management specialists
  •     Consultants/service providers
  •     Executive management
  •     General/corporate counsel
  •     R&D staff
  •     Regulatory/legislative affairs professionals

Webinar Details:
Choosing the Right Drug Name:
Increase Your Chances for Approval by FDA and Health Canada
Jan. 20, 2016 — 1:30 p.m. – 3:00 p.m. EST
http://www.fdanews.com/rightdrugname

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/rightdrugname
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
+1 (703) 538-7665
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