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Vigilance and Incident Reporting of Medical Devices per MDR 2017/745 
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Starodub’s eCTD team present at eCTD v4.0 Masterclasses
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Product for Diagnostic Purposes: Medical Device or Medicinal Product
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Impact of the new EU Artificial Intelligence Act on medical devices
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New revision of Guideline on Environmental Risk Assessments by EMA
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Windsor Framework – Changes to the licensing of medicines for human use in the UK (and affecting Northern Ireland)
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Unlocking Innovation with EMA’s Innovation Task Force
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The International Recognition Procedure (IRP) for Medicinal Products in the UK
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Understanding the Differences Between Medical Devices with Ancillary Substances and Substance-Based Medical Devices
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Seamless Transition to eCTD in Ukraine: Discover Our Services
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Sharing the power of teamwork!
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Revised ICH guideline Q2(R1) on Validation of Analytical Procedures
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When to Submit a New 510(k) for Medical Device Changes?
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Zero Day MR Procedure
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New ICH guideline Q14 on Analytical Procedure Development
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Regulatory Affairs is like searching for Easter eggs!
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Little knowledge about the influence of herbal remedies on medicines
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Top 10 Deficiencies in New Applications for a Certificate of Suitability (CEP)
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Metehan Agaca
Senior RA Consultant
Metehan Agaca

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