Understanding EMA’s “Guideline on quality and equivalence of locally applied, locally acting cutaneous products” and the implications for IVRT.
With the European Medicines Agency’s recently updated new guidance on demonstrating quality and equivalence of locally applied, locally acting cutaneous products—and the implications for IVRT—expectations are evolving rapidly.
The new guidance makes our informative, free webinar timely and important for anyone involved in the development, testing, or regulatory submission of topical formulations. If you work with generic or innovator topical products, you’ll gain targeted, must-have intelligence.
During this free, 45-minute webinar plus Q&A session, we’ll provide expert education and advice while answering the most-asked, most-relevant questions on the EMA’s new guideline.
Your presenter
Sascha Gorissen is the co-founder and head of laboratory at RaDes, a German company specializing in contract formulation development. Sascha has over 25 years of experience in the pharmaceutical industry, with deep expertise in preclinical development, pharmaceutical analytics, and project management. His insights will be invaluable for anyone looking to understand how to apply the EMA guideline in a practical, scientifically sound way.
What you’ll learn about IVRT under the new EMA guideline
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Insight into the new EMA guideline for topicals
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Implications for IVRT
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Quality and equivalence expectations
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Guideline compliance
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Insight into IVRT method development, method validation and data evaluation under the new guideline