SOURCE: Xtalks

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November 01, 2017 14:56 ET

Drug Name Development: The Regulatory Changes to Know About & How to Prepare for a Successful 2018, New Webinar Hosted by Xtalks

TORONTO, ON--(Marketwired - November 01, 2017) - Did you know every 6-month delay to launch can mean an average loss of $100 million[1]? Depending on the market you're looking to launch a product in, or what phase your drug sits in development, there are different regulatory factors and milestones you need to be aware of. When it comes to naming your asset, you need a partner to guide you through these milestones to develop the best regulatory submission strategy.

In 2017, the FDA introduced new guidance for naming biosimilars and biologics[2], and the EMA made changes to their name review schedule that will impact submission deadlines and planning[3]. This year, the industry began to understand the impact Health Canada's 2015 naming guidance is having on drug name approvals.

But how do these changes affect your trade name development and regulatory name submission strategies?

During this webinar you will learn about securing drug name approvals from three major regulatory bodies:

  • FDA
    • Overview of the 2017 guidance for non-proprietary naming of biological products
    • Prospective Naming vs. Retrospective Naming of Biologicals
    • Helps ensure your tradename will gain regulatory approval
  • EMA
    • Recent changes to the EMA NRG review schedule and how this impacts your asset's timeline
    • Recommendations for successful name submissions with the EMA NRG
  • Health Canada
    • Insights from two years after Health Canada released the agency's updated naming guidance, including best practices and recommendations moving forward
  • Preparing for 2018 and best practices to set up your name submissions for success

The informative live session featuring speakers from the global branding firm, Addison Whitney, takes place on Monday, November 6, 2017 at 11am EST (4pm GMT).

For complimentary registration please visit: Drug Name Development: The Regulatory Changes to Know About & How to Prepare for a Successful 2018.

To learn more about Addison Whitney visit http://www.addisonwhitney.com

ABOUT XTALKS

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners (from pharmaceutical & biotech companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit http://xtalks.com

For information about hosting a webinar visit http://xtalks.com/sponsorship.ashx

[1] Invention Reinvented, McKinsey Perspectives on Pharmaceutical R&D, 2010

[2] Nonproprietary Naming of Biological Products, https://www.fda.gov/downloads/drugs/guidances/ucm459987.pdf, 2017

[3] EMA Pre-authorisation guidance, http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/q_and_a/q_and_a_detail_000167.jsp&mid=WC0b01ac0580b18196

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