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.
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.
This webinar covers 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 EU.
Topics include:
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- Pathway to approval in the US vs EU
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- Potential impact of the draft EMA guidance on development planning and regulatory strategy
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- Key considerations for designing and operationalizing a maintenance study in MDD
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- Proactive planning for globalization
Speakers:
Adam Simmons
Vice President, Program Strategy, Neuroscience
Premier Research
Federica Martini, PhD
Associate Director, Regulatory Affairs
Premier Consulting
