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Insightful Seminar on Navigating Upcoming EU Pharmaceutical Legislation Changes
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Author: Dr Rebekka Bitsch, FORUM Institut
für Management GmbH
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The online seminar "EU Pharmaceutical Legislation - Consequences for your Regulatory Strategy" took place in German language on December 8, 2023 and offered a detailed insight into the upcoming changes to EU pharmaceutical legislation and their effects on the regulatory strategy of pharmaceutical companies.
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Are you interested in an update on the EU pharmaceutical legislation process, the panned changes and the effects on future applications for marketing authorisations of medicinal products?
Check out the online seminar "Update zur Revision der EU-Arzneimittelgesetzgebung" (in German language) that we offer in April 2024.
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News from European Commission |
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Tackling antimicrobial resistance (AMR) is an integral part of many actions under the European Health Union. Ahead of the European Antibiotic Awareness Day (EAAD), new data published by the European Centre for Disease Prevention and Control (ECDC) shows some overall progress between 2019 and 2022 towards the target to cut antimicrobial use by 20% by 2030.
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News from EMA |
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The Human Harmonisation Group has analysed the change requests received upon opening the eCTD EU Module 1 Specification for review and is now publishing the draft documents for public consultation.
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The EMA has relaunched its official website. With a focus on user-friendly navigation and a modernized design, the new website is tailored to help users find essential information effortlessly.
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News from BfArM and PEI |
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The BfArM has published its impulse report for 2023. With the subtitle "Enabling the future of medicine", the report offers impulses on topics such as the revision of EU pharmaceutical legislation or the use of artificial intelligence in regulation.
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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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