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X-WR-CALDESC:Veranstaltungen für AGAH
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DTSTART:20150329T010000
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DTSTART;VALUE=DATE:20150623
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SUMMARY:6th AGAH Dermatology Product Development Workshop
DESCRIPTION:The 6th AGAH Dermatological Product Development Workshop was held June 23-24\, 2015\, in London\, UK. 71 participants from 12 countries helped make this international workshop focused on bridging strategies from early development to regulatory approval a resounding success. The workshop featured an outstanding speaker panel of experts from industry\, academics and the MHRA. \nMany of the current issues and challenges in the development of both innovative and generic topically applied drug products were addressed. Key approaches interlaced throughout the two-day workshop included \n\nBuilding confidence towards selection of clinical candidates using a tool-kit approach\nRisk mitigation strategies for major vs. minor formulation changes during development\nIndication specific development strategies\nRegulatory perspectives from both sides of the pond\n\nThe workshop provided a unique platform to discuss practical and regulatory aspects of dermatological development which are critical to risk mitigation and success of new products from the perspective of both big pharma and leading dermatology companies to small biotech start-ups. An engaged audience contributed to lively question and answer sessions with discussions continuing in the networking breaks. \nThe AGAH would like to especially thank the industry sponsors without whom this workshop would not have been possible as well as the speakers\, moderators and attendees who contributed to making this workshop a huge success! \n\n\n\n\n\n\n\n\n\n\n\nInformationen\n\n\n6th Dermatological Product Development Workshop\n23.06.2015 – 24.06.2015 in London\, UK\n\n\n\n\nAn International Workshop on Bridging Strategies from Early Development to Regulatory Approval\n\n\nBuilding confidence towards selection of clinical candidate using tool kit approach\nRisk mitigation strategies for major vs. minor formulation changes during development\nIndication-specific development strategies\nRegulatory perspectives from both sides of the pond\n\n\n\n\nDay 1: 23.6.2015 Tuesday\n\n\n\n\nTime\nContent\nLecturer\n\n\n08:45\nWelcome and introduction on behalf of the AGAH\nBetsy Hughes-Formella\, bioskin\, Germany\n\n\n\n\n\n\nSession 1\n\n\n\n\nModerator: Marc Brown\n\n\n\n09:00\nQuality by Design (QbD) approach for topical formulation development: Utilization of Critical Material Attributes (CMAs) and Critical Process Parameters (CPPs) that are linked to the Critical Quality Attributes (CQAs) in order to develop a topical product\nVijendra Nalamothu\, USA\n\n\n09:45\nPredicting\, measuring and optimising drug delivery to the skin\nRichard Guy\, UK\n\n\n10:30\nBreak\n\n\n\n\n\n\n\nSession 2\n\n\n\n\nModerator: Vijendra Nalamothu\n\n\n\n11:00\nA fresh look on the relationship of dermal drug delivery and physicochemical properties\nLeandro Santos\, Stiefel\, a GSK company\, USA\n\n\n11:30\nThe importance of drug disposition in the skin\nHans Hofland\, USA\n\n\n12:00\nReducing the risk of topical formulation development: the optimal route from drug candidate selection to proof of concept studies\nMarc Brown\, UK\n\n\n12:30\nBreak\n\n\n\n\n\n\nSession 3\n\n\n\n\nModerator: Jon Lenn\n\n\n\n14:15\nTCAT: a novel PBPK model sheds light on the role of formulation on dermal pharmacokinetics\nRichard Lloyd\, UK\n\n\n14:45\nIncreasing confidence in candidate selection through repurposing and in vivo screening\nEdward Hsia\, USA\n\n\n15:30\nBreak\n\n\n\n16:00\nUse of high resolution actigraphy and advanced signal processing to quantify nocturnal scratching events in patients with atopic dermatitis\nBarry T. Peterson\, USA\n\n\n16:30\nTranslational biomarkers in dermatological drug development\nMads Almose Røpke\, Denmark\n\n\n17:00\nFibroTx TAP: A novel skin-ELISA platform technology for non-invasive biomarker measurements from skin\nPieter Spee\, Estonia\n\n\n17:30\nEnd of day one\n\n\n\n19:30\nDinner Meeting\n\n\n\n\n\n\n\nDay 2: 24.6.2015 Wednesday\n\n\n\n\nSession 4\n\n\n\nTime\nContent\nLecturer\n\n\n\nModerator: Betsy Hughes-Formella\n\n\n\n08:30\nSurrogate methods for bioequivalence of locally acting topical products: Optimization and IVIVC\nIsadore Kanfer\, SA\n\n\n09:00\nTissue specific PK and PD enabled by Open Flow Microperfusion (OFM): From bioequiva-lence to mechanism of drug action PoC studies\nFrank Sinner\, Austria\n\n\n09:30\nNanoscale phenotyping reveals barrier dysfunction of the skin at a subclinical level\nChristoph Riethmueller\, Germany\n\n\n10:00\nBreak\n\n\n\n10:30\nApplying a patient centric strategy in design of new innovative products for people with psoriasis\nKarsten Petersson\, Denmark\n\n\n11:15\nMitigation of the risks: Clinical development plan\nKarl R. Beutner\, USA\n\n\n12:00\nBreak\n\n\n\n\n\n\n\nSession 5\n\n\n\n\nModerator: Melissa Green\n\n\n\n13:30\nDifferences and similarities between US and EU clinical endpoint studies for generic drug approval\nCharles Bon\, USA\n\n\n14:00\nRegulatory considerations of bioequivalence in generic topical formulation development: In vitro or in vivo\nIan Claydon\, Marc Brown\, UK\n\n\n14:30\nBreak\n\n\n\n15:00\nRegulatory experience and challenges with topical drug development\nQuan Yang\, MHRA\, UK\n\n\n15:30\nBuilding a weight of evidence to support modifications to novel topical formulations during development\nMelissa Green\, USA\n\n\n\n\n\nSession 6\n\n\n\n\nModerator: Melissa Green\n \n\n\n16:00\nStrategic panel discussion \nWays to streamline topical drug development and mitigate risk throughout development \n\n\n\n\n17:00\nEnd of day two\n\n\n\n\n\n\n\nSponsors\n\n\n\n\nSilver Sponsors\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\nBronze Sponsors\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\nOther Sponsors\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\nRegistration Fee\n\nEarly registration until April 30\, 2015\n\n\n\n950€\nNon-Members\n\n\n750€\nMember of the AGAH\n\n\n\nRegistration after April 30\, 2015\n\n\n\n1050€\nNon-Members\n\n\n850€\nMember of the AGAH\n\n\n\nThe participation fee is per person. Please note: according to §4\, para. 22\, German Turnover-Tax Law workshop fees are exempt from VAT. Registration fees are charged and collected on behalf of AGAH e.V. (PO Box 10 14 58\, 41546 Kaarst\, VAT No: 122/5786/2578). All bookings are subject to change. \n\n\n\n\nWorkshop Venue\n\nThe Cumberland Hotel\, London\nGreat Cumberland Place\nLondon\, W1H 7DL\, United Kingdom \n\n\n\nRegistration\n\nCSi Hamburg GmbH\nJungfrauenthal 22 · 20149 Hamburg\, Germany\nTel.: +49 40 30770 300 Fax: +49 40 30770 301\nE-Mail: agah-veranstaltungen ( a t ) csihamburg.de \nMay we please ask you to use the registration form. \n\n\n\nRoom Reservations\n\nRoom reservations are possible at conference rates and\ncan also be made using the online-registration.\n \n\n\n\nScientific Committee\n\n\nMarc Brown\, MedPharm\nMelissa Green\, Stiefel\, a GSK company\nBetsy Hughes-Formella\, bioskin\nJon Lenn\, Stiefel\, a GSK company\nVijendra Nalamothu\, Tergus Pharma\n\n\n\n\nOrganization\n\n\nIlka Schmeichel\, bioskin\nAndrea Schmidt\, bioskin\n\n\n\n\nSupporting Society\n\n\nThe Association for Applied Human Pharmacology (AGAH) is a scientific medical non-profit organisation with members from the field of explorative drug development and human pharmacology. \n\n\n\n\n\nSpeakers\n\n\nKarl R. Beutner\, MD\, PhD\nChief Medical Officer\, Rogne Bioscience Inc.\, USA\nCharles Bon\, MS\nPresident\, Biostudy Solutions\, LLC\, NC\, USA\nProfessor Marc Brown\, BSc (Hons)\, Ph. CChem FRSC\nChief Scientific Officer and Chief Operating Officer MedPharm\, Guildford\, UK\nIan Claydon\nRegulatory Consultant\, UK\nMelissa Green \nDirector\, Global Regulatory Affairs\, PSO and AD Care Area\, Stiefel\, a GSK company\, USA\nProfessor Richard Guy\nUniversity of Bath\, Department of Pharmacy & Pharmacology\, UK\nHans Hofland\, PhD\nVP Research and Nonclinical Development Dermira\, USA\nEdward Hsia\, PhD\nDirector\, Dermatology Research\, Allergan\, USA\nIsadore Kanfer\, PhD\nChief Executive Officer\, CRO Consulting\, South Africa\nRichard Lloyd\nModeling and Transational Biology\, DMPK\, GlaxoSmithKline\, UK\nVijendra Nalamothu\, PhD\nCo-founder & CEO\, Tergus Pharma\, USA\nBarry T. Peterson\, PhD\nSr. Manager\, Clinical Affairs\, Philips Healthcare\, USA\nKarsten Petersson\, \nPrincipal Scientist & Project Lead\, PharmTech Ideation\, LEO Pharma\, Denmark\nChristoph Riethmuller\, PhD \nSerendip GmbH\, Center of Nanotechnology\, Muenster\, Germany\nMads Almose Røpke\,\nSenior Principal Scientific Advisor\, Clinical Pharmacology\, LEO Pharma\, Denmark\nLeandro Santos\nManager\, Topical Drug Delivery\, Stiefel\, a GSK company\, USA\nFrank Sinner\, PhD \nDirector Health – Institute of Biomedicine and Health Sciences\, Joanneum Research\, Graz\, Austria\nPieter Spee\, PhD MSc Ing\nChief Technology Officer\, FibroTx LLC\, Tallinn; Estonia\nQuan Yang\, PhD\, MPharm\nPharmaceutical Assessor\, Licensing Division\, MHRA\, UK
URL:https://dev.agah.eu/event/6th-agah-dermatology-product-development-workshop/
LOCATION:AGAH Workshop\, London\, Großbritannien (Vereinigtes Königreich)
CATEGORIES:Workshops
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