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Editorial
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Author Dr Birgit Wessels, FORUM Institut für
Management GmbH
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On July 26th 2024 Dr Cornelia Hunke contributed to the live webcast series PharmaFORUM Webcast Biologics with her talk on "ICH Q 9 "Quality Risk Management" - What to watch out for?". She covered the following content: Risk management as general topic, update on the new revision, tips for the implementation (it’s never to late), useful tools for handling risks, hands-on tips and suitable tools.
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“Mastering ICH Quality Guidelines: From Development to Lifecycle Management” - After participating in this seminar (English-speaking) you will be aware of the relation between the guidelines ICH Q8 to ICH Q12. This will enable you to recognise the opportunities of ICH Q12 and to profitably put the requirements of the guideline into practice.
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News from European Commission |
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Regulation (EU) 2024/1938 on standards of quality and safety for substances of human origin intended for human application has been published on 17 July 2024.
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During the seminar "All about ATMP", 26-27 September 2024, experts will (only) touch on the topic SoHO. In May 2025 we’ll schedule a more specific seminar (German-speaking): "Human-Gewebe/Gewebezubereitungen zur Anwendung am Menschen" – watch out for it.
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News from EMA |
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The draft guideline on the chemistry of active substances can be commented on by 31 January 2025.
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Learn how to accurately and efficiently compile RA- and GMP-relevant documents for APIs in the marketing authorisation documentation (EU-CTD, ASMF, CEP) during the German-speaking seminar “Pharmazeutische Wirkstoffe: Von der Syntheseentwicklung zum CMC Dossier”.
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The stakeholder consultation for the new classification guideline for variations is running until 23 August 2024.
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The German-language seminar "Variations für Praktiker" gives an update on variations including the new variation regulation (entry into force 1 January 2025) and the new classification guideline (entry into force date not yet known).
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The EMA has updated information about the European Shortages Monitoring Platform (ESMP).
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If you are interested in the German and European measures for shortage monitoring please have a look at the German-language seminar "Lieferenpassmanagement in der Praxis".
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News from BfArM and PEI |
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Fifth appointment period (starting in March 2025) of the joint expert commission on the classification of substances (commission on the classification of borderline substances placed on the market as food or food ingredient food or food ingredient placed on the market).
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The bulletin on drug safety has been published in issue 2/2024.
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Veterinary news |
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The concept paper on the revision of the guideline on dossier requirements for anticancer medicinal products for dogs and cats can be commented on by 31 October 2024.
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The concept paper for the revision of the guideline on the conduct of bioequivalence studies for veterinary medicinal products can be commented on by 31 October 2024.
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The concept paper on the revision of the guideline on user safety for pharmaceutical veterinary medicinal products can be commented on by 31 October 2024.
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Guidance is available from the European Medicines Agency (EMA) on veterinary post-authorisation measures in the form of questions and answers (Q&As). Last updated: 15 July 2024.
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EMA has published the final Q&A document on classification of veterinary medicinal products.
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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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