Navigation Links
FDAnews Announces — Choosing the Right Drug Name: How to Increase Your Chances for Approval Webinar, July 22, 2014
Date:7/18/2014

Falls Church, VA (PRWEB) July 18, 2014

Choosing the Right Drug Name:
How to Increase Your Chances for Approval
**FDAnews Webinar**
July 22, 2014 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/ChoosingRightDrugName

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

Not surprisingly, the drug industry has long 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So, in May 2014, the FDA released a draft guidance that covers the selection and approval process for proposed names of both prescription and nonprescription human drugs and biologics.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 a company should follow in choosing a drug name.

To address this issue, FDAnews has teamed with drug-naming expert Dr. Susan Proulx to present a 90-minute webinar that will look closely at the draft guidance and its recommended 4-step process. Dr. Proulx will provide ideas on how to win the FDA’s 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 impact on drug trademark development (in time, money, and the differences from country to country that affect processing for 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 the chosen drug name
  •     The need for expert analysis before deciding what trademark to choose

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.

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:
How to Increase Your Chances for Approval
**FDAnews Webinar**
July 22, 2014 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/ChoosingRightDrugName

Tuition:
$487 per site -- includes webinar registration and audio cds and transcripts

Easy Ways to Register:
Online:     http://www.fdanews.com/ChoosingRightDrugName
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.

Read the full story at http://www.prweb.com/releases/FDAnews/RightDrugName/prweb12030304.htm.


'/>"/>
Source: PRWeb
Copyright©2014 Vocus, Inc.
All rights reserved

Related medicine news :

1. FDAnews Announces — Improving Your FDA Import Success Rate: Tips for Thinking Ahead of the FDAWebinar, Aug. 7, 2014
2. FDAnews Announces Device Software Verification and Validation: Get Ready for a New Breed of Investigators, On-Demand Webinar, Aug. 12, 2014
3. FDAnews Announces CDRH’s Office of Compliance Reorganization: A “One-On-One” with Office Director Steve Silverman, Webinar, Feb. 5, 2014
4. FDAnews Management Report: Implementing Risk-Based Verification and Validation
5. FDAnews Management Report: Managing Contract Manufacturers and Testing Labs
6. FDAnews Announces The FDA Unique Device Identification (UDI) Rule Virtual Conference
7. HurricaneShuttersFlorida.com Announces Hurricane Season Special Offers on their Complete Line of Accordion Hurricane Shutters
8. Sharon Kleyne Hour Power of Water Announces International Water Conference in Bulgaria
9. Valued Pharmacy Services Announces Joint Venture With Truveris
10. First Choice Emergency Room Announces Dr. Gorav Bohil as Medical Director of Southeast Allen Facility
11. South Portland Marijuana Doctor Announces Grand Opening of New Alternative Practice in Maine
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/24/2017)... , ... February 24, 2017 , ... Healthcare Associates ... Medical Center at Craig Ranch building at 8080 State Highway 121, Suite 210, McKinney, ... with easy access to Highway 121. , As the practice has grown, the need ...
(Date:2/24/2017)... ... , ... With ProGlass Prism users now have the ability to simulate prism ... position, rotation, distortion, edge softness, edge blur, chromatic aberration, individual glass position offset, anchor ... Prism users are given the tools and effects to generate a fractal prismatic ...
(Date:2/24/2017)... , ... February 24, 2017 , ... Yisrayl Hawkins, Pastor ... on Bible Prophecy concerning this present generation. Yisrayl makes an astounding statement when ... generation. He explains that the Bible details the current times so plainly that ...
(Date:2/24/2017)... , ... February 24, 2017 , ... Indiana Fiber Network ... the company later this year. Dyer started as the Chairman of the Management ... the establishment of the corporation including the recruitment of investor/owners and development of the ...
(Date:2/24/2017)... Lawn, NJ (PRWEB) , ... February 24, 2017 ... ... with robust marketing services, which specializes in thought leadership , media relations, ... marketing campaigns and services that will be powered through Act-On, an intuitive marketing ...
Breaking Medicine News(10 mins):
(Date:2/24/2017)... SILVER SPRING, Md. , Feb. 23, 2017 ... today allowed marketing of the PhenoTest BC Kit, ... first test to identify organisms that cause bloodstream ... organism is likely to respond to (antibiotic sensitivity). ... it takes to provide this important information, which ...
(Date:2/24/2017)... -- Directors from Pharma To Market Pty Ltd and Ador Consulting Pte ... the founding of Pharma To Market Pte Ltd, based in ... to announce their expansion into Asia with ... The company are delighted to appoint Joelle Chia , former ... based entity. Joelle brings with her an extensive business ...
(Date:2/24/2017)... Medivir AB (Nasdaq Stockholm: MVIR) today announced ... Directors that will be submitted to the 2017 Annual ... the company,s three largest shareholders at the end of ... seat on the Nomination Committee, and the Chairman of ... was as follows:  Anders ...
Breaking Medicine Technology: