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Online PharmaFORUM – "Drug co-distribution: PV challenges"
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Author: Dr C. Michaela Gottwald, FORUM Institut für Management GmbH
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| On September 15, 2023, the Online PharmaFORUM took place on the topic of "Drug co-distribution: PV challenges". The speakers Dr Christian Moers and Dr Axel Thiele explained the basics of drug co-distribution and highlighted the specific requirements with regards to pharmacovigilance.
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News from EMA |
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EMA and EUnetHTA have published the report on the implementation of the EMA-EUnetHTA 21 workplan 2021 – 2023.
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EMA has updated the "IRIS guide for applicants" on 3rd October.
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You are interested in an update on the latest electronic submission necessities including usage of the EMA-IRIS-portal? More information on our German language seminar “eSubmission - Ihre To-dos 2023” can be found here.
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EMA has updated the guidance on "pre-authorisation procedural advice for users of the centralised procedure" on 29th September.
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News from European Commission |
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The European Parliament initiates the legislative process for the EU pharmaceutical package. On September 20, the ENVI Committee (Committee on Environment, Public Health, and Food Safety) in the European Parliament held a joint debate on the pharmaceutical package, engaging in a discussion with the Commission. The recording of the meeting can be watched here.
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The changes in the EU pharmaceutical legislation will have far-reaching implications for various aspects of European drug approval procedures. With a strategic regulatory approach, you can significantly expedite authorization processes in the future, streamline your work efficiently, and manage maintenance activities faster. You want to update yourself operationally and strategically to the latest standards and the potential changes in EU pharmaceutical legislation? More information on our German language seminar “EU Pharmaceutical Legislation - Konsequenzen für Ihre Regulatory Strategy” can be found here.
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News from BfArM and PEI |
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German BfArM announces changes according to § 5 of the Package Size 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
Quality, Safety, CMC
+49 6221 500-652 |
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