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30.06.2022
CIO Views honors Dr. Stephanie Plassmann as one of the 10 Most Empowering Women in Business 2022
Our team is proud to share the exciting news that Dr. Stephanie Plassmann has been honored by CIO Views as one of the 10 Most Empowering Women in Business 2022. For further information, see here The 10 Most Empowering Women in Business 2022 | ...
31.03.2022
Global Business Leaders elects PCS to one of the 20 Leading Companies of the Year 2022
PCS has been elected by Global Business Leaders to one of the 20 Leading Companies of the Year 2022. For further information, see here 20 Leading Companies Of The Year 2022 (globalbusinessleadersmag.com) Supporting the customer's complex ...
14.03.2022
Course: Pre-Clinical and Clinical Safety in Early Development Human Trials
Dr. Plassmann lectured about the topic Pharmacology Studies at the Course: Pre-Clinical and Clinical Safety in Early Development Human Trials organised by the Association Française de Pharmacologie Translationelle (AFPT), the Club Phase I ...
28.02.2022
The Silicon Review elects PCS to one of the 30 Most Reputable Companies of the Year 2022
PCS has been elected by The Silicon Review to one of the 30 Most Reputable Companies of the Year 2022. For further information, see here Magazine | 30 Most Reputable Companies of the Year 2022 (thesiliconreview.com) A high-performing drug ...
11.11.2021
Introductory Course in Exploratory Medicines Development - Part II Online Course
In her role as a regent for the Association of Applied Human Pharmacology ( www.agah.eu ), Dr. Plassmann contributed to develop this AGAH introductory course from the outset and lectures on non-clinical development . Since many years,...
27.10.2021
5th AGAH Webinar on COVID-19 Vaccines
Dr. Plassmann presented on the topic Juvenile and Reproductive Toxicity at the 5th webinar in the series offered by the AGAH in 2021, providing a forum for regular updates on the development of vaccines to prevent infection with SARS-CoV-2....
01.08.2021
Pharma Tech Outlook elects PCS as Editor's Choice amongst the Top 10 Drug Discovery and Development Solution providers in Europe 2021
Pharma Tech Outlook elects PCS as Editor's Choice amongst the Top 10 Drug Discovery and Development Solution providers in Europe 2021 For further information see here Drug Discovery and Development Europe special edition PCS: PCS: ...
01.06.2021
4th AGAH WEBINAR ON COVID-19 VACCINES
The 4th webinar in the series offered by the AGAH in 2021 providing a forum for regular updates on the development of vaccines to prevent infection with SARS-CoV-2 will be held on June 16, 2021. More information can be found on the AGAH website: ...
17.05.2021
Read the latest manuscript published by AGAH
Dr. Plassmann co-authored this article which summarises the discussion at the forum hosted by the Association for Applied Human Pharmacology (AGAH e.V.) in November 2019 to critically debate how to interpret and optimise the Investigator’s Brochure ...
16.05.2021
3rd AGAH WEBINAR ON COVID-19 VACCINES
The third webinar in the series offered by the AGAH in 2021 providing a forum for regular updates on the development of vaccines to prevent infection with SARS-CoV-2 will be held on May 26, 2021. More information can be found on the AGAH website: ...
21.04.2021
2nd AGAH WEBINAR ON COVID-19 VACCINES
The second webinar in the series offered by the AGAH in 2021 providing a forum for regular updates on the development of vaccines to prevent infection with SARS-CoV-2 was held on April 21, 2021. More information can be found on the AGAH website: Update ...
27.03.2021
PACTT Pfizer Academy Drug discovery and development
Dr. Plassmann was invited by the PACTT Pfizer Academy to lecture on the topic: "Non-Clinical Development – Concepts, Strategies and Potential Pitfalls" which covered the key aspects of non-clinical drug development such as the regulatory framework,...
10.02.2021
1st AGAH Webinar on COVID-19 Vaccines
Dr. Plassmann actively engages in a series of webinars held by the AGAH in 2021 providing a forum for regular updates on the development of vaccines to prevent infection with SARS-CoV-2. In this first webinar, she presented on the pharmacological and ...
10.01.2021
AGAH manuscript accepted for publication
Today, the AGAH manuscript "How to Interpret an Investigator’s Brochure for Meaningful Risk Assessment – Results of an AGAH Discussion Forum", has been accepted for publication in Therapeutic Innovation & Regulatory Science. Dr....
13.09.2020
Introductory Course in Exploratory Medicines Development - Part II Online Course
In spite of the Corona pandemic, PCS contributes to the AGAH introductory course with a one-day lesson on non-clinical development this year again. This course is now an established training for post-graduates interested in the early clinical ...
13.11.2019
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 ...
21.07.2019
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....
30.04.2019
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 ...
05.04.2019
April 2019: Introductory Course in Exploratory Medicines Development - Part II
PCS contributed to the AGAH introductory course this year again which is now an established training for post-graduates interested in the early clinical development of medicinal products. The course is PharmaTrain certified. Two training parts over a total ...
25.01.2019
2-DAY AGAH Workshop Implementation of translational appraoches
This workshop was held in Bonn January 24 - 25, 2019. In her role as regent on behalf of the AGAH, Dr. Plassmann was actively involved in the planning and organisation of this workshop on translational aspects from preclinical to clinical studies during the ...
07.11.2018
AGAH-Workshop on the implementation of TRANSLATIONAL APPROACHES to support dose selection and dose escalation schemes in early clinical trials
will be held in Bonn January 24 - 25, 2019. In her role as regent on behalf of the AGAH, Dr. Stephanie Plassmann is actively involved in the planning and organisation of this workshop on translational aspects from preclinical to clinical studies during the ...
06.06.2018
DGPHarMed Workshop Neuss June 07, 2018
Dr. Plassmann presented on the impact of toxicological studies on clinical development. ...
27.04.2018
27th AGAH ANNUAL MEETING 2018: Target organs in early medicines development – predictability and prevention of adverse reactions
Dr. Stephanie Plassmann was invited to speak about "Safety assessment of hepatic findings in non-clinical studies" at the 27th Annual Conference held by the AGAH. The meeting fostered lively discussions and a very constructive exchange between ...
27.02.2018
AGAH Workshop at German Pharm-Tox Summit February 28th, 2018
AGAH organised a workshop at the 3rd German Pharm-Tox Summit, Göttingen (February 26th – March 1st , 2018): First-in-human trials – What you need to know. The German Pharm-Tox Summit is a joint meeting of the 84th ...
29.01.2018
AGAH Introductory Course in Exploratory Medicines Development – Part II
PCS contributes to the AGAH introductory course this year again which is now an established training for post-graduates interested in the early clinical development of medicinal products. The course is PharmaTrain certified. Two training parts over a total ...
22.11.2017
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....
23.10.2017
DGPHarMed Workshop Mannheim, November 13, 2017
Dr. Plassmann will present on the impact of toxicological studies on clinical development. ...
22.10.2017
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 ...
21.08.2017
PCS continues to support ETS sustaining membership scheme
PCS is pleased to announce its continued support of the ETS sustaining membership scheme for another year which PCS has supported ever since its introduction in the year 2014. On the ETS website, the purpose of the membership scheme is explained "to ...
19.07.2017
Non-clinical development - practical aspects, implementation and impact on medicine development
Dr. Plassmann presented at the 73rd DGPharMed Workshop held in Munich on July 19, 2017 to give an overview on critical aspects of non-clinical development and discuss practical examples. ...
13.05.2017
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,...
28.03.2017
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 ...
20.03.2017
Dr. Stephanie Plassmann presenting at the DGPharMed Annual Meeting in Berlin on March 24, 2017
Dr. Stephanie Plassmann will present at the 33rd DGPharMed Annual Meeting in Berlin on March 24, 2017 during Symposium 6: What‘s up in Clinical Trials and the Regulatory Arena? Dr. Plassmann will talk about the role of ...
14.02.2017
Book chapter authored by Dr. Elisabeth Koch and Dr. Stephanie Plassmann published
Critical Aspects of Integrated Non-Clinical Drug Development: Concepts, Strategies and Potential Pitfalls in: A Comprehensive Guide to Toxicology in PreClinical Drug Development. Editor Ali S. Faqi. 2 nd edition ...
01.02.2017
Introductory Course in Exploratory Medicines Development – Part II
Dr. Stephanie Plassmann lectured on non-clinical development in this AGAH training course which addresses postgraduates in life sciences interested in early clinical development of medicinal products. Two training parts of 2.5 days each provide a concise ...
13.01.2017
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 ...
11.11.2016
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 ...
11.07.2016
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 ...
21.04.2016
AGAH 25th Annual Meeting in Berlin (21-22 April 2016)
Dr. Stephanie Plassmann was invited to speak ad hoc about the topic: "Immunological Aspects in the Non-Clinical Safety Assessment of Drugs in Development." ...
29.02.2016
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 ...
20.05.2015
Meet us in Brussels at the Joint Conference of European Human Pharmacological Sciences 21 & 22 May 2015
PreClinical Safety (PCS) Consultants is excited to announce that for the first time we will be present at a conference with an exhibition and we decided to do this together with three other highly specialised service providers with unique expertise at the 3 ...
22.04.2015
AGAH Introductory Course in Early Medicines Development
PCS actively participates in training of postgraduates in the field of early medicines development. http://www.agah.eu/en/infothek/training/archive/introductory-course-in-early-medicines-development.html ...
26.02.2015
Presentations AGAH-Workshop "Expect the Unexpected" now online
The AGAH-Workshop: "Critical Aspects of Integrated Drug Development: Expect the Unexpected" was a great success and stimulated very lively discussions between participants. All those presentations which could be made available by the presenting experts ...
20.02.2015
AGAH-Workshop: Oncological Drugs: Early Development from pre-clinics to phase II
PCS participated actively in the above AGAH Workshop held in Frankfurt, which provided a forum for very stimulated discussions between workshop participants including from patient networks. Presentations which could be made available, including from Dr....
01.11.2014
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. ...
01.10.2014
Interview in European Business Journal
The EBJ published an interview with Dr. Stephanie Plassmann describing the services offered by PCS. ...
17.09.2014
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 ...
13.03.2014
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 ...
14.11.2013
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 ...
11.10.2013
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) ...
04.07.2013
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,...
02.05.2013
Publication in Pharmazeutische Medizin (DGPharMed Journal)
S. Plassmann Prädiktivität von toxikologischen Untersuchungen für die klinische Sicherheit von Arzneimitteln Pharmazeutische Medizin, DGPharMed Journal, Issue 2 (May 2013). ...
25.02.2013
AGAH PIP-Workshop: Pragmatic approaches to paediatric medicines development
S. Plassmann chaired the first session entitled: Translational aspects of PIP development ...
18.10.2012
14th Annual Conference for Clinical Pharmacology (VKliPHa)
S. Plassmann Predictivity of toxicological studies for the clinical safety of pharmaceuticals 14th Annual Conference for Clinical Pharmacology (VKliPHa), Rostock (18-20 October 2012) ...
11.10.2012
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....
25.03.2012
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 ...
21.03.2012
Abstract Publication in Naunyn-Schmiedeberg´s Archives of Pharmacology
C. Schleh, P. Takawale, S. Plassmann, A-L. Leoni Opportunities and Potential Pitfalls when using Computer Assisted Sperm Analysis (CASA) Naunyn-Schmiedeberg´s Archives of Pharmacology 385 (1): S82 (2012) Poster presented at the DGPT ...
13.03.2012
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: ...
31.03.2011
Joint Conference of European Human Pharmacological Societies and 20th Anniversary of AGAH
S. Plassmann Impact of the ICH M3 guideline on the early development of biologics Joint Conference of European Human Pharmacological Societies and 20th Anniversary of AGAH (31 March – 01 April 2011) ...
21.10.2010
AGAH Workshop The revised ICH M3 guideline - Impact on preclinical and clinical drug development
S. Plassmann ICH M3 (R2) 2009: Impact on preclinical drug development – selection of dose and duration of studies 21 Oktober 2010 The workshop was held in German language. The presentation can be retrieved from the AGAH Website. ...
09.09.2010
Publication in the Journal of Toxicologic Pathology
R. A. Ettlin, J. Kuroda, S. Plassmann, M. Hayashi, D.E. Prentice Successful drug development despite adverse preclinical findings. Part 2: Examples Journal of Toxicological Pathology 23: 213-234 (2010) ...
06.09.2010
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) ...