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Editorial
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In March 2026, Dr Cornelia Hunke, Head of
the Quality and Risk Management Department at the Evangelical
Hospital Göttingen-Weende and a consultant for GxP and ISO, led an
on-site in-house training on the topic of "Artificial Intelligence
in GxP" or "Quality over Hype - Using AI and Digital Tools in
Compliance: Seizing Opportunities, Avoiding Mistakes".
... Read more
In case you desire an update on AI matters in the GxP context FORUM
offers a couple of options:
Keen to hear about the changes due to the Revision of the EU GMP
Guideline during a half-day seminar: EU-GMP-Revision: Kapitel 4,
Annex 11, Annex 22 (in German) on 23 June 2026.
Details
Receive hands-on know-how on how to integrate AI technologies into
your daily GMP routine to improve efficiency: GMP trifft KI:
Effizienzsteigerung mit ChatGPT & Co. (in German) on 1 July
2026.
Details
In case you would like to discuss the challenges concerning the use
of modern technologies in the field of Computer System Validation
(CSV), this is the best option for you: Effiziente IT-Validierung
und neue Technologien im GxP-Bereich (in German) – 8 October
2026.
Details
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News from European Commission |
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The EU Commission has published the
implementing regulation on uniform quality management and procedural
requirements for the conformity assessment activities carried out by
a notified body under the MDR and IVDR.
Details
The European Commission is seeking
views on EU health priorities and strategic orientations, to feed
into the preparation of the EU4Health work programme 2027.
Details
EU-supported initiative strengthens
Luxembourg’s epidemiological preparedness and response.
Details
The EU Commission has published the
harmonised standards under the medical devices Regulation.
Details
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News from EDQM |
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EDQM has published a new Official Control
Authority Batch Release (OCABR) guideline covering all mRNA
vaccines produced using lipid nanoparticles (LNPs), and two
revised guidelines covering pertussis and herpes zoster (rDNA)
vaccines.
Details
The Council of Europe Committee of
Ministers has adopted Recommendation CM/Rec(2026)7 on best practices
for the remote and online provision of medicines.
Details
EDQM announced the launch of the
European Drug Shortages Formulary (EDSForm) platform.
Details
EDQM has published the revised
“Guideline on requirements for revision and renewal of certificates
of suitability to the European Pharmacopoeia monographs” – CEP.
Details
Amongst others important
knowledge, the latest details on ASMF and CEP procedures is
addressed during the seminar
APIs in the dossier: Quality data, e-submission, global
regulatory strategy (in English) on 29-30 September
2026.
Details
EDQM has published its new
“Guidelines on best practices for the traceability of medicines
in hospital settings”.
Details
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News from EMA |
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EMA has published a Data Protection Notice concerning
the use of clinical study data for modelling and simulation
activities carried out, on a pilot basis, in support of the
provision of scientific advice.
Details
The strongly recommended use of the PLM web-based electronic
Application Form (eAF) for Centrally Authorised Products (CAPs) has
been in place since July 2024. To continue advancing the adoption of
the PLM web-based eAF, the European Medicines Agency (EMA) will
introduce mandatory use for CAPs as of 1 September 2026.
Details
A general introduction to the variation framework including an
update on the web-based eAF is provided in the seminar
Regulatory Lifecycle Management (in
English) – 10 June 2026.
Details
If you want a comprehensive update on the EMA-IT systems and the
handling of the PLM web-based eAF this seminar might be of interest
for you: Regulatory Operations Update (in German) – 15-16
July 2026.
Details
EMA has published a Data Protection Notice for the implementation of
the Instrument for Pre-accession Assistance (IPA) programme.
Details
EMA published a revised draft
guideline “on declaration of herbal substances and herbal in
herbal medicinal products /traditional herbal medicinal products” to
be commented on by 30 June 2026.
Details
If you want a comprehensive
overview on the regulatory requirements for herbals, from marketing
authorisation to post-approval management this seminar might be
relevant for you:
Lehrgang: Regulatorische Anforderungen für
Phytopharmaka (in German) – 12-14 October 2026.
Details
If you rather need a
thorough introduction to the topic of herbal medicinal products this
seminar could be an option: Phytopharmaka & Homöopathika:
Regulatory-Affairs-Essentials (in German) – 24 November 2026.
Details
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News from CMDh |
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The CMDh has corrected the Q&A-list for the submission
of
variations for human medicinal products.
Details
If you need an introduction or an update on the classification and
submission of variations with practical examples and a workshop this
seminar might be relevant: Qualitätsbedingte Variations (in
German) – 30 June-01 July 2026.
Details
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News for Veterinary medicines |
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The concept paper “on the development for guidance on demonstration
of biosimilarity of biological veterinary medicinal products”
can be commented on by 31 July 2026.
Details
The Forum Institute is offering a seminar entitled
"Pharmakovigilanz bei
Tierarzneimitteln"
(in German) on 29 - 30 June 2026.
Details
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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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