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DTSTART:20180325T010000
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DTSTART;VALUE=DATE:20180605
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DTSTAMP:20260929T021312
CREATED:20190510T104046Z
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SUMMARY:AGAH-Workshop “Introduction into Basic Principles of Pharmacokinetics”
DESCRIPTION:  \n\nPharmacokinetics – prerequisite and at the same time “door opener” for understanding pharmacology!\n\nThis workshop\, developed by experienced specialists from industry\, CRO and consultancy\, offers an entrée to physiological background\, measures and characteristics of pharmacokinetics. It helps to understand study design and evaluation of PK studies and the conclusions drawn from the results. \nThe workshop has been developed for clinical investigators\, project leaders\, project managers and monitors as well as PhD students in industry\, hospitals\, university and CROs. The knowledge obtained in this applied introductory course helps beginners in pharmacokinetics obtaining the basic knowledge and scientific background for professional handling\, evaluation and interpretation of PK data. \n\n\n\n	Day 1 \n\nDay 1: Tuesday\, 05 June 2018\n\n\n\n\n08:00\n Registration\n\n\n08:30\n Welcome and introduction of participants and speakers \nBarbara Schug\, Oberursel (Germany) \n\n\n\n08:45\n Human physiology: what you should know to better understand pharmacokinetics \nAn overview of physiological characteristics being of (PK)-relevance for Absorption\, Distribution\, Metabolism and Elimination (ADME) \nRoland Heinig\, Wuppertal (Germany) \n\n\n\n09:30\n How to measure what happens in pharmacokinetics: PK metrics of relevance! \nAn introduction into how one can quantify what the body does to the drug\, i.e. which measures describe what happens to the drug including relevant methods of calculation \nHelmut Schütz\, Vienna (Austria) \n\n\n\n10:15\n Break\n\n\n10:30\n In vitro ADME & preclinical PK \nDescription of in vitro ADME parameters\, such as Cytochrome P450 & drug transporter inhibition\, drug absorption\, plasma protein binding\, and metabolic clearance; explanation of preclinical animal PK results and their translation to the human situation \nThomas Arnhold\, Biberach (Germany) \n\n\n\n11:30\n Human PK studies Ia: bioequivalence\, food interaction and drug-drug-interaction studies – Part 1 \nPresentation of basic principles and design features such as choice of dosing\, treatment and sampling schedule\, evaluation approaches as well as population characteristics \nRalph-Steven Wedemeyer\, Oberursel (Germany) \n\n\n\n12:00\n Discussion and Questions\n\n\n12:30\n Break\n\n\n13:30\n Human PK studies Ib: bioequivalence\, food interaction and drug-drug-interaction studies – Part 2 \nPresentation of basic principles and design features such as choice of dosing\, treatment and sampling schedule\, evaluation approaches as well as population characteristics \nRalph-Steven Wedemeyer\, Oberursel (Germany) \n\n\n\n14:30\n Human PK studies IIa: Special populations characteristics considering liver\, kidney and age – Part 1 \nAssessment of factors that relevantly impact PK in patients in adequately designed clinical trials considering authorities’ requirements \nRoland Heinig\, Wuppertal (Germany) \n\n\n\n15:00\n Break\n\n\n15:15\n Human PK studies IIb: Special populations characteristics considering liver\, kidney and age – Part 2 \nHow to assess factors that relevantly impact PK in patients in adequately designed clinical trials considering authorities’ requirements \nRoland Heinig\, Wuppertal (Germany) \n\n\n\n16:15\n Hands-on clinical PK – the practical exercise: \nHow to design your PK program? An exercise with the goal to plan your own clinical PK program based on a preclinical data set \nAll \n\n\n\n17:45\n Discussion and Questions\n\n\n18:15\n End of Day 1\n\n\n\n\n\n\n\n	Day 2 \n\nDay 2: Wednesday\, 06 June 2018\n\n\n\n\n08:30\n Introduction to biologics: what you should know to understand their pharmacokinetics \nAn overview of their molecular characteristics which interfere with pharmacokinetics – which types\, characteristics and differences are of relevance \nStephan Glund\, Biberach (Germany) \n\n\n\n09:15\n Human PK – What’s different in biologics? Part 1 \nAn introduction into bioanalytical methods\, antibody development and their assessment\, specificities in ADME\, TMDD\, immunogenicity\, drug-drug interaction and comparability / biosimilars \nStephan Glund\, Biberach (Germany) \n\n\n\n10.00\n Break\n\n\n10:15\n Human PK – What’s different in biologics? Part 2 \nAn introduction into bioanalytical methods\, antibody development and their assessment\, specificities in ADME\, TMDD\, immunogenicity\, drug-drug interaction and comparability / biosimilars \nStephan Glund\, Biberach (Germany) \n\n\n\n11:00\n Human PK studies III: interplay between biopharmaceutics and absorption \nWhat you should know about galenics and biopharmaceutics to understand the interplay between formulation principles and pharmacokinetics \nRalph-Steven Wedemeyer\, Oberursel (Germany) \n\n\n\n12:30\n Discussion and Questions\n\n\n13:00\n Break\n\n\n14:00\n Human PK studies IV: Mass balance / Metabolism \nWhatever goes in should get out! \nThomas Arnhold\, Biberach (Germany) \n\n\n\n14:45\n Pitfalls in BA/BE: \nAttempts in beating Murphy’s law: Learnings from failures in study design\, bioanalytics and statistics \nHelmut Schütz\, Vienna (Austria) \n\n\n\n15:30\n Break\n\n\n14:45\n Where all ends meet – PK information in the label \nReview of a PK program – What\, When\, How – and Why? \nWolfgang Mück\, Wuppertal (Germany) \n\n\n\n17:00\n Discussion and Questions\n\n\n17:35\n End of Day 2\n\n\n\n\n\n\n\n	Language \nEnglish \n\n\n\n\n	Organisation \nAttendance Fees\n\n\n\n680€\nNon-Members\n\n\n430€\nMember of AGAH\, EUFEMED or one of the VKliPha-Societies or Junior Scientist up to the age of 30\n\n\n\nThe participation fee is per person. Please note\, according to §4 para 22 German turnover tax law\, registration and workshop fees are exempt from VAT. Registration fees are charged and collected on behalf of AGAH e.V. \nAll bookings are subject to change \nRegistration Deadline: May 21\, 2018 \n\n\n\n\n	Faculty \nDr. Thomas Arnhold\nHead of Data Evaluation and Reporting\,\nClinical PK/PD\nBoehringer Ingelheim Pharma GmbH & Co. KG\nBiberach (Germany) \nDr. Stephan Glund \nHead of Team 2\nProject Clinical Pharmacokineticists\, Clinical PK/PD\nBoehringer Ingelheim Pharma GmbH & Co. KG\nBiberach (Germany) \nDr. Roland Heinig\nDirector PK Exp\nert\, Clinical Pharmacokinetics\,\nCardiovascular\nBayer AG\, Pharmaceuticals\nWuppertal (Germany) \nDr. Wolfgang Mück\nHead of Clinical Pharmacokinetics\, Cardiovascular\nBayer AG\, Pharmaceuticals\nWuppertal (Germany) \nHelmut Schütz\nBEBAC – Consultancy Services for Bioequivalence and\nBioavailability Studies\nVienna (Austria) \nDr. Ralph-Steven Wedemeyer\nAdvisor Biopharmaceutics;\nHead of Pharmaceutical Technology\nSocraTec R&D GmbH\nOberursel (Germany) \n\n\n\n\n	Registration  \n\nCSi Hamburg GmbH\nConferences | Symposia | Incentives\nGoernestraße 30\n20249 Hamburg\nGermany \nphone: +49 40 30770300\nfax:    +49 40 30770301\ne-Mail: agah-meetings ( a t ) csihamburg.de \n\n  \n\n\n\n\n	Contact \nAssociation for Applied Human Pharmacology (AGAH) e.V.\noffice: Goernestraße 30\n20249 Hamburg \nphone: +49 170 7844438\ne-Mail: info ( a t ) agah.eu \n\n\n\n\n	ORGANISATION \nWorkshop Fee \n400 € Non-Member \n300 € Member of AGAH | EUFEMED and DGKliPha or young scientistics until the age of 30 years \n100 € Member of Regulatory Agencies and ethics commission \nDelegate number is limited to 70 persons. \nFinal Registration: November 1\, 2019
URL:https://dev.agah.eu/event/agah-workshop-introduction-into-basic-principles-of-pharmacokinetics/
LOCATION:AGAH Workshop\, Oberursel\, Deutschland
CATEGORIES:Training
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