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X-WR-CALDESC:Veranstaltungen für AGAH
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DTSTART:20150329T010000
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DTSTART:20151025T010000
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DTSTART;VALUE=DATE:20150615
DTEND;VALUE=DATE:20150617
DTSTAMP:20260929T023413
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UID:2550-1434326400-1434499199@dev.agah.eu
SUMMARY:New European Guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms
DESCRIPTION:Save the date announcement for a brand new workshop! \nThe development of modified release formulations still is a challenge for applicants and authorities as well. From ‚which studies are needed when‘ to ‚how to optimize the study design‘ – a broad variety of scientific and regulatory aspects need to be considered for new modified release forms of new chemical entities and known drugs\, but also for abridged applications. \nThe new European Guideline has brought some changes and also some clarification especially with regard to orally administered drugs. The first day of this workshop is intended to adress specifically the new requirements regarding oral formulations. \nThe second day will focus on patches regarding the PK studies necessary but also of course patch adhesion trials and skin irritation and sensitization studies. \nThe workshop is intended for participants from industry- and CRO side as well as for regulators and investigators involved in drug development. A group of highly experienced experts together with representatives from authorities will present the relevant aspects to be observed and will share their specific experience and knowledge with you. \nThe workshop has been initiated by AGAH together with the EUFEPS Network on Bioavailability and Bioequivalence. \n\n\n\n\n\n\n\n\n\n\n\nInformationen\n\n\nThe new European Modified release Guideline\nfrom cook book to interpretation – June 15 – 16\, 2015 Bonn\, Germany\n\n\n\n\nIntroduction\n\nRationale for the workshop\nThe development of modified release formulations still is a challenge for applicants and authorities as well. From “which studies are needed when” to “how to optimize the study design” – a broad variety of scientific and regulatory aspects need to be considered for new modified release forms of new chemical entities and known drugs\, but also for abridged applications. \nThe new European Guideline has brought some changes and also some clarification especially with regard to orally administered drugs. The first day of this workshop is intended to address specifically the new requirements regarding oral formulations. \nThe second day will focus on patches regarding the PK studies necessary but also of course patch adhesion trials and skin irritation and sensitization studies. \nThe workshop is intended for participants from industry- and CRO side as well as for regulators and investigators involved in drug development. \nA group of highly experienced experts together with representatives from authorities will present the relevant aspects to be observed and will share their specific experience and knowledge with you. Each presentation is scheduled with 30 Minutes maximum to allow for a minimum of 10 Minutes discussion. \nThe workshop has been initiated by AGAH together with the EUFEPS Network on Bioavailability and Bioequivalence. \n\n\n\nDay 1: 15.6.2015 Monday\n\n\n\n\nTime\nContent\nLecturer\n\n\n10:00\nWelcome\nHenning Blume\, Oberursel/Erfurt\n\n\n10:10\nIntroduction into the regulatory concept\nHenrike Potthast\n\n\n10:50\nMR products developed as line extension of already approved IR formulations\nHenning Blume\, Oberursel/Erfurt\n\n\n11:30\nBreak\n\n\n\n12:00\nBioequivalence of MR products\nGerald Beuerle\n\n\n12:40\nSummarising discussion\nAll speakers\n\n\n13:00\nBreak\n\n\n\n14:00\nPK characteristics and statistical evaluation of BE studies: how to handle the newly introduced endpoints and how to apply adaptive designs\nRalph-Steven Wedemeyer\, Oberursel\n\n\n14:40\nFood effect studies with MR products – when and how?\nBarbara Schug\, Oberursel/Erfurt\n\n\n15:20\nMR dosage forms with special release characteristics\nHenning Blume\, Oberursel/Erfurt\n\n\n16:00\nPitfalls and problems – what do we learn from the regulatories‘ experience\nHenrike Potthast\, Bonn\n\n\n16:40\nSummarising discussion\nAll speakers\n\n\n\n\n\n\nDay 2: 16.6.2015 Tuesday\n\n\n\n\n09:00\nWelcome\nBarbara Schug\, Oberursel/Erfurt\n\n\n09:10\nBiopharmaceutical properties of patches relevant for transdermal drug absorption – confounding factors and in-vitro testing\nJohannes Bartholomäus\, Aachen\n\n\n09:50\nPatch development with new drugs versus generic development – principles and methods\nBarbara Schug\, Oberursel/Erfurt\n\n\n10:30\nBreak\n\n\n\n11:00\nHow to design skin irritation / sensitization studies\nWalter Wigger-Alberti\, Hamburg\n\n\n11:40\nHow to realise patch adhesion studies\nAndré Warnke\, Oberursel\n\n\n12:20\nPitfalls and problems – what do we learn from the regulatories‘ experience\nJanet Schriever\, Bonn\n\n\n13:00\nSummarising discussion\nAll speakers\n\n\n\n\n\n\n\nAttendance Fees Day 1 / Day 2\n\n\n\n\n400€ / 200€\nNon-Members\n\n\n300€ / 150€\nMember of AGAH\, DGPharMed or DGKliPha 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. All bookings are subject to change. \n\n\n\n\nContact\n\nAssociation for Applied Human Pharmacology (AGAH) e.V.\nPostfach 10 14 58\nD-41546 Kaarst\nPhone: +49 (0)2131-2018194\nEmail: info ( a t ) agah.eu\nWeb: www.agah.eu \n\n\n\nAccomodation\n\n\nThere is a limited number of rooms reserved at Hilton Bonn. Reservation can be made in context with your workshop registration. \n\n\n\n\nProgramme Committee\n\n\nHenning Blume\, SocraTec R&D\, Oberursel/Erfurt\nBarbara Schug\, SocraTec R&D\, Oberursel/Erfurt\nHildegard Sourgens\, München\nHenrike Potthast\, Bonn\n\n\n\n\nWorkshop Venue\n\nHilton Bonn\nBerliner Freiheit 2\n53111 Bonn / Germany\nwww.hiltonhotels.de \n\n\n\nRegistration\n\nCSi Hamburg GmbH\nAntje Blömeke | Matthias Runow\nJungfrauenthal 22 · 20149 Hamburg\, Germany\nTel.: +49 40 30770 300 Fax: +49 40 30770 301\nE-Mail: agah-veranstaltungen ( a t ) csihamburg.de\nWeb: www.csihamburg.de \n\n\n\n\n\n\n\n\n\n\n\n\n\n\nDownloads\n2._H._Blume-MR_products_as_line_extension_of \n1._U._Potthast-Introduction_into_the_regulatory_concept \n4._B._Schug-Food_effect_studies_with_MR_products_-_when_and_how \n7._B._Schug-Patch_development_with_new_drugs_versus_generic_development_… \n6._J._Barthlomaeus-Biopharmaceutical_properties_of_patches_relevant_for_t… \n5._H._Blume-MR_dosage_forms_with_special_release_characteristics_ \n3._G._Beuerle-Bioequivalence_of_MR_products
URL:https://dev.agah.eu/event/new-european-guideline-on-the-pharmacokinetic-and-clinical-evaluation-of-modified-release-dosage-forms/
LOCATION:Translational Approaches\, Bonn\, Deutschland
CATEGORIES:Workshops
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