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X-WR-CALDESC:Veranstaltungen für AGAH
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DTSTART:20140330T010000
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DTSTART:20141026T010000
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DTSTART;VALUE=DATE:20141128
DTEND;VALUE=DATE:20141130
DTSTAMP:20260929T023338
CREATED:20190604T211331Z
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SUMMARY:Critical Aspects of Integrated Drug Development – Expect the Unexpected!
DESCRIPTION:Expect the unexpected – this AGAH workshop provides practical insight into critical situations arising during successful drug development with a focus on non-clinical and clinical development of biologics and anti-cancer drugs. Moreover\, specific aspects regarding reproductive and juvenile toxicity and drug development for the paediatric patient population will be addressed. \nHow can we mitigate potential risks in humans? How reliably can we translate data from animals or clinical studies to the patient target population? How can we responsibly balance potential risks against essential benefits? \nThe audience is invited to discuss these aspects in depth with experts from health authorities\, industry and academia presenting at the meeting. \nThe workshop will be held in the beautiful city of Munich at the beginning of the pre-Christmas period at the \nKardinal-Wendel-Haus Munich\nMandlstrasse 23\nD-80802 Munich \n\n\n\n\n\n\n\n\n\n\n\nInformations\n\n\nAGAH-Workshop “Critical aspects of integrated drug development – expect the unexpected!”\n28.11.2014 – 29.11.2014 in Munich\n\n\n\n\nIntroduction\n\nDrug development presents the experts in all disciplines involved with unexpected challenges during the complex process it takes to bring new medicines in a variety of indications to the market. These challenges require integration into what proves to be a demanding journey through often unknown territories which need to be explored as the route unfolds itself on the way. \nWhat do we understand at a specific moment in time when we are facing an issue? Will this issue be a “show stopper” or only make us take a more complicated but still potentially successful route? How can we mitigate potential risks in humans? How reliably can we translate data from animals or clinical studies to the patient target population? How can we responsibly balance potential risks against essential benefits? How certain can we be as to whether we have asked the right questions along the way? Are we sure that we do really understand the answers we get? \nExpect the unexpected – this AGAH workshop provides practical insight into critical situations arising during successful drug development with a focus on non-clinical and clinical development of biologics and anti-cancer drugs. Moreover\, specific aspects regarding reproductive and juvenile toxicity and drug development for the paediatric patient population will be addressed. \n\n\n\n\nDay 1: 28.11.2014\n\n\n\n\nTime\nContent\n\n\n\n\n09:00\nRegistration\n\n\n10:00\nWelcome and Introduction \nS. Plassmann\, Munich  \n\n\n\n10:15\nThe realms of drug development – how can we achieve better? \nA. Kovar\, Darmstadt \n\n\n\n\n\n\n\nSession 1: “Biologics” – a challenging and diverse field in drug development\n\n\n\n\nChairs: H. Sourgens and B. Ziegele\n\n\n10:45\nWhat are we talking about? An overview on biologics: a regulatory perspective \nB. Ziegele\, Langen \nQuestions\, Answers and Discussion \n\n\n\n11:30\nCritical aspects of the clinical development of biologics \nD. Seimetz\, Munich \nQuestions\, Answers and Discussion \n\n\n\n12:15\nBreak\n\n\n13:15\nCMC and immunogenicity aspects of the development of biosimilars \nP. Chamberlain\, Munich \nQuestions\, Answers and Discussion \n\n\n\n14:00\nPK/PD and safety assessment of biologics to support early clinical development \nJ. Sims\, Basel \nQuestions\, Answers and Discussion \n\n\n\n14:45\nRound table discussion \n“The Good\, the Bad and the Ugly” and how to deal with them \nAll Workshop participants \n\n\n\n15:15\nBreak\n\n\n\n\n\nSession 2: Oncology – surprises guaranteed!\n\n\n\n\nChairs: B. Schug and S. Leclair\n\n\n15:45\nNon-clinical development of anti-cancer medications \nE. Koch\, Denver \nQuestions\, Answers and Discussion \n\n\n\n16:30\nHow to bring targeted anti-cancer agents to the market today: an industry perspective \nA-R. Hanauske\, Bad Homburg \nQuestions\, Answers and Discussion \n\n\n\n17:15\nRound table discussion \n“A high unmet medical need and the specific challenges of fighting cancer” \n\n\n\n17:45\nEnd of Day 1\n\n\n19:00\nGet-together in Munich City\n\n\n\n\n\n\n\nDay 2: 29.11.2014\n\nSession 3: Reproductive and juvenile toxicity and paediatric drug development – “Everything you always wanted to know but were too afraid to ask”\n\n\n\n\nChair: L. Wiesner and G. Bailey\n\n\n09:00\nIntroduction \nS. Plassmann\, Munich \n\n\n\n09:15\nThe applicability of animal reproductive data in human drug safety \nS. Plassmann\, Munich \nQuestions\, Answers and Discussion \n\n\n\n10:00\nFrom clinical data to new therapeutic concepts for paediatric patients \nC. Mallard\, Gothenburg \nQuestions\, Answers and Discussion \n\n\n\n10:45\nBreak\n\n\n11:15\nJuvenile animal studies for new chemical entities: PIPs\, pups and problems \nG. Bailey\, Beerse \nQuestions\, Answers and Discussion \n\n\n\n12:00\nJuvenile toxicity studies with biopharmaceuticals: considerations and current practices \nS. Maguire\, Cambridge \nQuestions\, Answers and Discussion \n\n\n\n12:45\nPaediatric trials – daily challenges in clinical practice \nV. Klingmann\, Düsseldorf \nQuestions\, Answers and Discussion \n\n\n\n13:30\nRound table discussion \n“How to protect the young\, the very young and those not even born: take the challenge and expect the unexpected” \nAll Workshop participants \n\n\n\n14:00\nClosing remarks \nS. Plassmann\, Munich \n\n\n\n14:10\nFarewell\n\n\n\n\n\n\n\nSpeakers and Chairs\n\n\nGraham Bailey\, Johnson & Johnson\, Beerse (Belgium)\nPaul Chamberlain\, Biopharma Excellence\, Munich (Germany)\nAxel-Rainer Hanauske\, Lilly Deutschland GmbH\, Bad Homburg (Germany)\nViviane Klingmann\, Universitätsklinikum Düsseldorf\, Düsseldorf (Germany)\nElisabeth Koch\, PreClinical Safety Consultants Ltd.\, Denver (USA)\nAndreas Kovar\, Consultant\, Darmstadt (Germany)\nStéphane Leclair\, Roche Diagnostics GmbH\, Penzberg (Germany)\nShaun Maguire\, Medimmune (AZ Biologics)\, Cambridge (UK)\nCarina Mallard\, University of Gothenburg\, Gothenburg (Sweden)\nStephanie Plassmann\, PreClinical Safety Consultants Ltd.\, Basel (Switzerland)\nBarbara Schug\, Socratec R&D GmbH\, Oberursel (Germany)\nDiane Seimetz\, Biopharma Excellence\, Munich (Germany)\nJennifer Sims\, Integrated Biologix GmbH\, Basel (Switzerland)\nHildegard Sourgens\, Consultant\, Munich (Germany)\nLutz Wiesner\, Bundesamt für Arzneimittel und Medizinprodukte\, Bonn (Germany)\nBettina Ziegele\, Paul-Ehrlich-Institut\, Langen (Germany)\n\n\n\n\n\nOrganisation\n\nAttendance Fees\n\n\n\n450€\nNon-Members\n\n\n300€\nfor Members of AGAH\, DGPharMed\, DGKliPha\, BAPU\, Club Phase I and AHHPI as well as for young scientists 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 work-shop 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. \nAccommodation at the conference venue can be booked separately at registration. \nOn-site registration is possible! \n\n\n\n\nRegistration\n\nCSi Hamburg GmbH\nJungfrauenthal 22\n20149 Hamburg\nGermany \nTel.: +49 40 30770300\nFax: +49 40 30770301\nE-Mail: agah-veranstaltungen ( a t ) csihamburg.de\nMay we please ask you to use the registration form. \n\n\n\n\n\n\nRegistration Form AGAH Workshop 28-29 Nov 2014.pdf\nRegistration Form \n\n\n\n\n\n\nWorkshop Venue\n\nKardinal-Wendel-Haus Munich\nKatholische Akademie in Bayern\nMandlstraße 23\n80802 Munich \n\n\n\nContact and further information\n\nAssociation for Applied Human Pharmacology (AGAH) e.V.\nPostfach 10 14 58\nD-41546 Kaarst\nGermany \nPhone: +49 (0)2131-2018194\nEmail: sekretariat ( a t ) agah-web.de\nWeb: www.agah-web.de or http://www.agah.eu \nThis workshop is supported by PreClinical Safety (PCS) Consultants Ltd.\n\n\n\n\n\n\n\n\n\n\nDownloads\nMaguire_Juvenile_toxicity_studies_with_biopharmaceuticals_considerations_and_current_practices-website \nMallard_New-therapeutic-concepts-paedatrics \nPlassmann_Applicability-reprotox_human-safety_F2.0-webiste \nSeimetz_Clinical-development-biologics-for-handout \nSims_PK_PD-safety-assessment-biologics-website \nZiegele_InnovationOffice_PEI__RegulatoryOverview \nBailey_Pips_pups_and_problems_pdf_2 \nKlingmann-Paediatric_trials_-_daily_challenges_in_clinical_practice_WITHOUT_pictures \nKoch_Non-clinical-development-anticancer-medications_F1.0-webiste
URL:https://dev.agah.eu/event/critical-aspects-of-integrated-drug-development-expect-the-unexpected/
LOCATION:Kardinal-Wendel-Haus\, München\, Deutschland
CATEGORIES:Workshops
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