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BIO KOREA 2025 – Building a Healthier World Together
April 23, 2025
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Easter Lunch
April 23, 2025
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✈️Boost Your Clinical & Regulatory Success in EU – Join Our Free Webinar!
April 8, 2025
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World Health Day and World Parkinson’s Day
April 7, 2025
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Navigating the Evolving Regulatory Landscape of ATMPs and Medical Devices
April 3, 2025
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New on Our Website: Smart Navigation & Support!
April 1, 2025
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EMA Considerations regarding the implementation of ICH M13A on bioequivalence for immediate-release solid oral dosage forms
March 27, 2025
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No ASMF Procedure for Biological Drug Substances? Here’s What You Need to Know
March 18, 2025
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Human Medicines in 2024 (overview)
March 11, 2025
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FDA Updated Guidance on Nitrosamine Impurities
March 4, 2025
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Regulatory challenges in the classification of drug-device combinations
February 27, 2025
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One standardized icon set for clearer medication information
February 18, 2025
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EMA Updates Post-Approval Application Guidance Effective 1 January 2025
February 12, 2025
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Updates on eCTD Submissions for the EU: Are You Ready?
February 7, 2025
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How ready are you for MDR submission?
January 28, 2025
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Regulatory Affairs: A Marathon of Dedication and Strategy
January 10, 2025
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Looking Back on Milestones and Forward to the Future
December 18, 2024
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Interpretation of Well-Established Technology (WET) under the EU MDR
December 11, 2024
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Femke Jacobs
Senior RA Consultant
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