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News from the EU Commission |
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Rev.1 of the Guidance "on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD" has been published by the Medical Device Coordination Group.
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For the latest news we recommend the "Crash Course: Medical Device Regulation".
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News from the ICH |
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The ICH E6(R3) draft Guideline on "Good Clinical Practice (GCP)" has reached Step 2 of the ICH process on 19 May 2023.
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Our experts will support you in the safe and efficient selection and sustainable maintenance of your quality management system on November 30 during the seminar "Qualitätsmanagementsysteme für moderne Laboratorien" (all kinds of laboratories will be focused).
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Or are you interested in digitisation topics in the context of "laboratory"? Then this new seminar could be just right for you – Labor 4.0: ISO- und GxP-Compliance erfüllen.
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The ICH S5 Guideline "on detection of reproductive and developmental toxicity for human pharmaceuticals" has been updated.
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News from EMA |
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EMA has published its 3rd eAF-PMS newsletter.
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For the latest information on PLM we recommend the German speaking course "Product Lifecycle Management (PLM) Portal in der praktischen Nutzung".
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News from BfArM and PEI |
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The PEI publishes: "Wie die Sicherheit von Arzneimitteln überwacht wird – Eine Einführung".
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Veterinary news |
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The US and the EU reached an agreement to mutually recognise the results of pharmaceutical Good Manufacturing Practices (GMP) inspections for veterinary products.
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Revision 1 of the VICH GL35 “Pharmacovigilance of veterinary medicinal products: electronic standards for transfer of data” will come into effect in March 2024.
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Kind regards,
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Dr Rebekka Bitsch
Your contact for
Regulatory Affairs (Human)
+49 6221 500-565 |
Dr C. Michaela Gottwald
Your contact for
Regulatory Affairs (Veterinary)
+49 6221 500-610 |
Dr Birgit Wessels
Your contact for
Quality, Safety,
CMC
+49 6221 500-652 |
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