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Editorial
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Author: Dr Rebekka Bitsch, FORUM Institut für
Management GmbH
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Summary of the online seminar "Environmental Risk Assessment (ERA) in Drug Approval"
The online seminar "Environmental Risk Assessment (ERA) in Drug Approval," held in German language on 10 September 2024, provided a comprehensive overview of the current requirements, legal frameworks, and practical challenges associated with the environmental risk assessment of pharmaceuticals in the EU. The seminar covered the fundamental aspects of ERA, the role of German regulatory authorities, the current guidelines, as well as specific case studies and applications in detail.
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News from ICH |
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The ICH M13A Guideline and associated Q&As on
"Bioequivalence for Immediate-Release Solid Oral Dosage Forms" reached Step 4 of the ICH Process on 23 July 2024.
This Guideline provides recommendations on conducting bioequivalence studies during both development and post approval phases for orally administered immediate-release solid oral dosage forms.
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The ICH E11A Guideline provides recommendations and promotes international harmonisation of paediatric extrapolation to support the development and authorisation of paediatric medicines.
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On 25 July 2024 an ICH reflection paper has been published on pursuing opportunities for harmonisation in using real-world data to generate real world evidence, with a focus on effectiveness of medicines.
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News from EMA |
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EMA has published a guidance document "on the use of medicinal products for treatment in case of exposure to chemical agents used as weapons of terrorism, crime, or warfare".
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EMA has published "Guiding principles on the use of large language models in regulatory science and for medicines regulatory activities".
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You want to learn how to use AI in your regulatory work? Check out our German language online seminar
"Praxisnahe Regulatory Intelligence mit KI-Unterstützung".
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News from BfArM and PEI |
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The BfArM has published the preliminary version of the operation and procedure code (OPS) 2025.
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Replacement of animal testing - rabbit pyrogen test largely cancelled.
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The Paul-Ehrlich-Institut informs about updated Simultaneous National Scientific Adivce (SNSA) procedures and gives recommendations on complex clinical trials in mononational clinical trials of the early development phase (Early Phase Complex Clinical Trials).
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Save the Date: "The Product is the Process – Is it?" Manufacturing and Translation of ATMPs and Tissue- & Cell-based products - In cooperation with the Paul-Ehrlich-Institut, the workshop for healthcare professionals will take place on 28 November 2024.
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You would like to learn more about the quality-related requirements during ATMP manufacturing? Come and visit the German language online seminar
"ATMPs/Gentherapeutika: Das 1x1 des Qualitäts- und Risikomanagements".
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Veterinary news |
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The BVL has published "Wichtige Hinweise zur Pharmakovigilanz für Inhaber von Freistellungen gemäß § 4 AMG".
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In January 2025, the Forum Institute will offer a German language online seminar on
pharmacovigilance for veterinary medicines and vetQPPV.
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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
CMC
+49 6221 500-652 |
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Verena Planitz
Your contact for
Global Regulatory Affairs
+49 6221 500-655
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