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Editorial
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Author: Dr Rebekka Bitsch, FORUM Institut
für Management GmbH
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The German language seminar titled "Artificial Intelligence in Drug Regulatory Affairs" was conducted on 17th April 2024 by experts Dr Matthias Rüdiger (Head of AI, INCONSULT GmbH) and Sebastian Bergmann (Head Regulatory Operations, STADA Arzneimittel AG) and offered an in-depth exploration of the integration of artificial intelligence (AI) in the pharmaceutical regulatory affairs sector
... more
A repetition of the seminar will take place on 25th September 2024. If you are interested you can find more information
here.
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News from ICH |
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ICH Q3C (R9) Guideline on impurities: guideline for residual solvents has come into effect on 29 April 2024.
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During the German speaking seminar “Verunreinigungen in Arzneimitteln - Fokus Nitrosamine”, the five experts will address all new insights that refer to the challenges regarding the handling of impurities, especially nitrosamines.
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News from EMA |
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From 4 June 2024, paediatric submissions
must be carried out via the IRIS online portal to EMA. This includes
paediatric investigation plans (PIP) and changes to it, waiver,
deferrals...
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The draft Guideline on the pharmaceutical quality of inhalation and nasal medicinal products can be commented on by 31 Oktober 2024.
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EMA has released a guidance document on the use of real-world evidence in regulatory decision making.
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News from BfArM and PEI |
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The BfArM has informed about the start of operations of the portal for reporting actively used active substance manufacturers, which was developed by the BfArM on the basis of the ALBVVG.
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The BfArM updated the information on the parallel distribution of medicinal products (annual update/notification of change, urgent safety update and bulk change) on 24th April.
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On 24th April, the BfArM announced the launch of the electronic portal for applying for sunset clause exemptions.
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Regulation of biomedical medicinal products: Paul-Ehrlich-Institut in dialogue with the German Pharmaceutical Industry Association – a summary of the convention on 29 April 2024.
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Biopharmeceuticals – The compact course with a focus on the development, production and analytics of biopharmaceuticals will take place from 24 till 26 June 2024.
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Veterinary news |
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The Guideline on determination of the need for an MRL evaluation for chemical-unlike biological substances will come into force from 1 August 2024 on.
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The draft guideline on stability testing for applications for variations to a marketing authorisation for veterinary medicinal products can be commented on until 31 August 2024.
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The Concept paper for the development of a guideline on the safety of nanoparticles – in the context of the establishment of maximum residue limits and veterinary marketing authorisations can be commented on until 31 July 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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