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News from ICH |
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The ICH M15 Guideline "General Principles for Model-informed Drug Development" has been adopted and will now enter the implementation phase.
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ICH has published the "Implementation Guide for Electronic Transmission of Individual Case Safety Reports, Module III for ICH Guideline E2B(R3)" one of a series of guidelines concerning Clinical Safety Data Management.
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The period for public consultation to Draft Guideline for Extractables and Leachables ICH Q3E ended for all countries/regions involved.
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Regulatory chair, Dr Katrin Buss (EC, Europe), and Samo Kuzmič Lead Project Manager, Global Development Center of Excellence for Extractables & Leachables, Sandoz Kek d.d. will equip you to navigate today's E&L regulatory landscape while anticipating tomorrow's guideline(s) (harmonisation between ICH Q3E and FDA USP E&L Chapters + BPOG):
Extractables & Leachables: Current CMC requirements in light of the upcoming ICH Q3E, 17 September 2026.
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News from HMA |
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New information on biologicals has been published in the Q&A section (February 2026).
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In case you desire a compact overview with a focus on the development, the production and the analytics of biopharmaceuticals, you shouldn’t miss the
English-language course “Biopharmaceuticals” – 8-10 June 2026.
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News from European Commission |
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The EC has launched a call for members of the Scientific Committee on Consumer Safety (SCCS). The deadline for online applications is 31 May 2026.
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News from EMA |
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The ACT EU initiative, jointly run by the EC, EMA and HMA, is publishing new draft guidance on the conduct of clinical trials during public health emergencies. This draft guidance document is open for public consultation until 30 April 2026.
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EMA has published a 3-year work plan for the clinical domain.
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EMA just published a Horizon Scanning Short Report: Review of AI/ML
applications in medicines lifecycle.
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EMA published a concept paper "on the development of a reflection paper on the non-clinical development and evaluation of microbiome-based medicinal products". It can be commented on by 30 April 2026.
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EMA published a concept paper "on the revision of the guidelines on Good Manufacturing Practice for medicinal products - Annex 15 - Qualification and Validation". It can be commented on by 9 April 2026.
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During the German-language course "Update: Methodenvalidierung & Transfer analytischer Methoden" – 22 April 2026, you will receive a general overview on the regulatory framework including the status of current guideline revisions.
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News from CMDh |
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CMDh hast published the summary report on the CMDh Multi-annual Workplan to 2025.
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News from BfArM/PEI |
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The Bulletin on drug safety, issue 1 will be published by the end of Q-1-2026.
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Kind regards,
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Jean-Marie Bayhurst
Your contact for
Regulatory Affairs (Human)
+49 6221 500-685 |
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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