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Recent developments in the medical industry, the latest research results, information for our customers and partners ...

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AGAH Discussion Forum in Bonn, November 11, 2019

This year's forum discussed "How to interprete an investigator's brochure for meaningful risk assessment".  Dr. Lutz Wiesner, BfArM and Dr. Plassmann, PCS presented together on the topic: Potential risks for human subjects associated with ...

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Save the date! AGAH Discussion Forum 2019

Dr. Plassmann will actively participate in the AGAH Discussion Forum 2019, held at the GSI - Gustav Stresemann Institut Bonn Langer Grabenweg 68 53175 Bonn on November 11 this year. See for more information on  https://www.agah....

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Juvenile Toxicity Symposium

Dr. Plassmann participated in the Juvenile Toxicity Symposium held at J&J in Belgium every 18 months to share her experience and expertise with those of other colleagues in this very special field and gave a presentation on the topic: "Perspectives for ...

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Publication in DGPharMed Journal Pharmazeutische Medizin

Drs. Koch and Plassmann were invited to contribute to the Journal with an article entitled: Non-Clinical Requirements for FIH and up to POC Clinical Studies  with the aim to give an overview on non-clinical testing up to Proof of Concept clinical trials....

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AGAH Discussion Forum November 8, 2017

Dr. Plassmann will contribute to this discussion forum about the practical implementation of the revised „Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products ...

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Visit Eufemed 2017 - London Conference

Next week, the European Federation for Exploratory Medicines Development will hold its bi-annual conference in London on the topic Innovation and Risk Management . The conference will take place at Kensington Conference and Events Centre, London,...

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EMA Workshop on revision of FIH guideline

On behalf of AGAH, Dr. Stephanie Plassmann, who serves as a regent for the Association of Applied Human Pharmacology, has attended the EMA workshop on the revision of the recently revised Guideline on strategies to identify and mitigate risks for ...

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AGAH discussion forum on comments to the FIH guideline

As a follow-up on the earlier discussion forum in November 2016, this discussion forum was held to develop comments to the revised FIH guideline (EMEA/CHMP/SWP/28367/07 REV.1). Mrs. Bettina Ziegele (PEI) and Dr. Stephanie Plassmann introduced and ...

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Risk management in exploratory medicines development

Dr. Stephanie Plassmann has evaluated the publicly available non-clinical information on the Bial study and presented the results during this AGAH discussion forum held in Bonn. The aim of this discussion forum was to work on any possible provisions to ...

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PCS experts authoring book chapter

Dr. Elisabeth Koch and Dr. Stephanie Plassmann were invited to author the following book chapter: "Critical Aspects of Integrated Non-Clinical Drug Development: Concepts, Strategies and Potential Pitfalls." In: A Comprehensive Guide to Toxicology in ...

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AGAH Workshop at German Pharm-Tox Summit

AGAH organised a workshop at the German Pharm-Tox Summit, Berlin (29 February – 03 March 2016). The German Pharm-Tox Summit was a joint meeting of the 82nd Annual Meeting of the German Society for Experimental and Clinical Pharmacology and ...

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1989 - 2014: 25 Years PCS!

Founded in 1989, PCS is celebrating its 25th anniversary in 2014. Read about the history and development of the company in an interview with Dr. Stephanie Plassmann recently published in the European Business Journal. ...

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AGAH Workshop

PCS actively gets involved in the training and development of fellow scientists through a range of voluntary activities in the scientific community. Dr. Stephanie Plassmann acts as a Regent on behalf of the AGAH (Association of applied human ...

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AGAH 23rd Annual Conference

S. Plassmann organised the Session "Risks identified from nonclinical development" as a Regent on behalf of the AGAH, chaired the session together with G. Wensing and presented on the following topic:  S. Plassmann Predictivity of ...

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AGAH Course: The Basics of Human Pharmacology

S. Plassmann Lecturer at the AGAH course The Basics of Human Pharmacology - An Introduction to the basics of human pharmacology and the practical, regulatory and ethical aspects of early phase clinical trials on the topic: Overview on preclinical ...

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AGAH Workshop Hormonal Contraceptives

S. Plassmann Reproductive toxicology – interpretation of data AGAH Workshop Hormonal Contraceptives: Development and their use in other trials in the fertile female population, Berlin (11-12 October 2013)  ...

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Publication in Journal of Lipid Research

Herman J. Kempen, Monica Gomaraschi, S. Eralp Bellibas, Stephanie Plassmann, Brad Zerler, Heidi L. Collins, Steven J. Adelman, Laura Calabresi, and Peter L. J. Wijngaard Effect of repeated apoA -IMilano/POPC infusion on lipids, (apo)lipoproteins,...

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AGAH Workshop Reproductive Toxicity

S. Plassmann organised this workshop as a Regent on behalf of the AGAH and presented on the following topics: S. Plassmann Study for effects on pre- and postnatal development, including maternal function (ICH) G. Bailey and S....

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Poster presentation ISA

H. J. Kempen, S. E. Bellibas, B. Zerler,  S. Plassmann, D. Goundis, P.L. J. Wijngaard Effects of MDCO-216 (Apo A-I Milano/POPC Complex) on Plasma Lipids and Apoprotein levels  in Cynomolgus Monkeys Poster for presentation at the XVI ...

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Abstract Publication in Circulation

H. J. Kempen, S. E. Bellibas, B. Zerler,  S. Plassmann, D. Goundis, P.L. J. Wijngaard MDCO-216 (Apo A-I Milano/POPC Complex) Administered to Cynomolgus Monkeys Induces Pronounced Changes in Plasma Lipids and Apolipoproteins. Circulation 124: ...

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Publication in the Journal of Toxicologic Pathology

R. A. Ettlin, J. Kuroda, S. Plassmann, D.E. Prentice Successful drug development despite adverse preclinical findings. Part 1: Processes to address issues and most important findings Journal of Toxicological Pathology 23: 189-211 (2010)  ...

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