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Editorial
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Author: Dr Rebekka Bitsch, FORUM Institut
für Management GmbH
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Our comprehensive online seminar “Regulatory Lifecycle Management” offered a deep dive into all aspects of maintenance activities throughout the product lifecycle. This one-day event was designed to provide participants with thorough training on important regulatory responsibilities encompassing dossier updates, variations, pharmacovigilance (PV) activities, and labelling maintenance duties.
... more
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News from ICH |
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The ICH E2D(R1) draft Guideline on "Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports (ICSRs)" reached Step 2b of the ICH Process and entered the consultation period.
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ICH M10 "Bioanalytical Method Validation and Study Sample Analysis" Training Material has been published.
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If you desire to discuss the current challenges on the validation and transfer of bioanalytical methods you are invited to our new seminar “Bioanalytik: Methodenvalidierung und -tranfer” on 23 October 2024.
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The ICH Q3C(R9) "Guideline for Residual Solvents" reached Step 4 of the ICH Process on 24 January 2024.
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News from European Commission |
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The draft implementing act of the EU HTA Joint Clinical Assessment has been published and can be commented on until 2 April 2024.
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The EU commission published a proposal for new measures for the better lifecycle management of medicine authorisations.
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News from EMA |
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The QRD (Quality Review of Documents) template v10.4 was revised to delete “United Kingdom (Northern Ireland)” from the list of local representatives in the package leaflet to comply with the Windsor Framework for labelling and packaging of medicines. In addition, Ema has implemented some other minor changes.
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News from BfArM and PEI |
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The BfArM will be a guest at DMEA 2024 (trade fair and congress for digital healthcare) from 9-11 April 2024.
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The PharmNet.Bund portal provides pharmaceutical companies with the new application "Active pharmaceutical ingredient manufacturers (ALBVVG)" for reporting the manufacturing sites of the active pharmaceutical ingredients actually used in the manufacture of medicinal
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What API data is required in the EU? - Our two experts will answer these and other questions during the new seminar “Wirkstoffdokumentation für Regulatory Affairs und GMP-Quality” on 15 May 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
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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