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| Going Global: Bringing Drugs for Depression to Market in the US and EU, Upcoming Webinar Hosted by Xtalks | ||
| By: PR Newswire Association LLC. - 20 Mar 2024 | Back to overview list |
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In this free webinar, gain insights into how to bring drugs for depression to market in the US and EU. Attendees will learn about the potential impact of the draft European Medicines Agency (EMA) guidance on development planning and regulatory strategy. The featured speakers will share key considerations for designing and operationalizing a maintenance study in major depressive disorder (MDD). The speakers will also share insights into the proactive planning required for targeting the global market. TORONTO, March 20, 2024 /PRNewswire-PRWeb/ -- An estimated 350 million people around the world live with major depressive disorder (MDD) and more than 700,000 die due to suicide every year. While existing treatments such as medications and psychotherapy can make a difference, there remains a critical need for more effective drugs that offer sustained relief and prevent relapses. Regulatory pathways are not harmonized, and a draft guideline released by the European Medicines Agency (EMA) may complicate plans for globalization. North America dominates the antidepressant drug market, and most developers first target approval in the US before seeking approval in other regions. However, the regulatory pathways are not harmonized, and a draft guideline released by the European Medicines Agency (EMA) may complicate plans for globalization. In this webinar, the expert speakers will cover the current guidance on MDD trials and explore strategies for navigating differences in regulatory requirements to efficiently bring drugs to market in both the US and the EU. Register for this webinar today to gain insights into how to bring drugs for depression to market in the US and EU. Join Adam Simmons, Executive Director, Clinical Program Strategy, Neuroscience, Premier Research; and Federica Martini, PhD, Associate Director, Regulatory Affairs, Premier Consulting, for the live webinar on Tuesday, April 9, 2024, at 11am EDT (4pm BST/UK). For more information, or to register for this event, visit Going Global: Bringing Drugs for Depression to Market in the US and EU. ABOUT XTALKS Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars and digital content to the global life science, food, healthcare and medical device communities. Every year, thousands of industry practitioners (from pharmaceutical, biotechnology, food, healthcare and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps professionals stay current with industry developments, regulations and jobs. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers. To learn more about Xtalks visit https://xtalks.com Media Contact Vera Kovacevic, Xtalks, +1 (416) 977-6555 x371, vkovacevic@xtalks.com, https://www.xtalks.com
SOURCE Xtalks 
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