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Das Lieferkettensorgfaltspflichtengesetz – nur was für "die Großen"?
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Von Dr. Andreas Müller
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Drei Gründe, warum sich auch Mittelständler mit
dem LkSG beschäftigen sollten.
Kaum ein nationales Gesetz hat bereits vor Inkrafttreten so viel
Diskussionen ausgelöst wie das Lieferkettensorgfaltspflichtengesetz
(LkSG). Auch die juristischen Ansichten gehen weit auseinander, wie
einige 1.000 Seiten an Kommentaren eindrucksvoll belegen. Hierbei werden
von verschiedenen Gruppen sich teilweise ausschließende Positionen
vertreten, was sowohl bei den LkSG-betroffenen Unternehmen als auch bei
Zulieferern der aktivierten Lieferketten erhebliche Verunsicherung
erzeugt. Formal gilt das Gesetz – vereinfacht formuliert - seit dem
01.01.2024 für Unternehmen mit mindestens 1.000 Mitarbeitern in
Deutschland.
... Mehr
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News from ICH |
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The guideline ICH Q5A(R2) on "viral safety evaluation of biotechnology products derived from cell lines of human or animal origin" is coming into effect on 14 June 2024.
Details
ICH Q14 "Analytical procedure development" will come into effect on 14 June 2024.
Details
Dr Markus Savsek will update you amongst others on new requirements and procedures with the effectiveness of the ICH Q14 and ICH Q2 within the scope of the German language seminar "Analytik kompakt für CMC" on 10 to 11 October 2024.
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News from European Commission |
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On 7 February 2024 the European Commission has published the draft for the new “Variation regulation” with a feedback period announced until 29 February 2024. The new regulation will amend regulation (EC) No 1234/2008.
Details
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News from EMA |
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On 12th January 2024 EMA has published a "Guidance on paediatric submissions" outlining the steps for paediatric submissions via the Syncplicity Web Client and including a list of required documents including Paediatric investigation plan (PIP).
Details
EMA has published a concept paper on "the establishment of a Guideline on the development and manufacture of human medicinal products specifically designed for phage therapy" which can be commented on until 31 March 2024.
Details
The electronic Application Form (eAF) and Product Management Service (PMS) teams provided an update on the progress of the web-based human variations eAF implementation in the Product Lifecycle Management (PLM) Portal.
Details
The EMA has revised and published the "Questions & Answers (Q&A)" documents relating to centralised authorisation procedures.
(1) Details during the application process
(2) Post-approval details
You will receive a comprehensive overview of the relevant topics on "Variations in Europe" from 15-16 May 2024.
Details
On 18th January EMA has updated the "IRIS guide for applicants".
Details
If you are interested in a comprehensive update on eSubmission related topics, please consider our German language seminar "eSubmission – Ihre ToDos 2024" on 14-15 May 2024.
Details
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News from EDQM |
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The CEP 2.0 guideline on requirements for the content of the dossier has been updated.
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Veterinary News |
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The draft guideline "on the evaluation of the benefit-risk balance of veterinary medicinal products" can be commented on until 30 June 2024.
Details
A new version of the eSubmission Gateway XML delivery file for veterinary Variations Requiring Assessment (VRA) now available.
Details
The Forum Institute is offering a seminar "Veterinary medicinal products: authorization and submission" (german language) on March 18, 2024.
Details
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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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