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Regulatory - PowerPoint Presentation

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Regulatory - PPT Presentation

Views on Pathology Results November 5 2015 Role of toxicological pathology in safety assessment of human pharmaceuticals Safety assessment of human pharmaceuticals is a multidisciplinary challenge Pharmacologists are involved in the discovery to find a drug for the intended target and ID: 364911

webinar ifstp november safety ifstp webinar safety november working human carcinogenicity testing evaluation registration regulatory important member 2015 pharmaceuticals

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Slide1

Regulatory

Views

on Pathology ResultsNovember 5, 2015

Role of toxicological pathology in safety assessment of human pharmaceuticals. Safety assessment of human pharmaceuticals is a multidisciplinary challenge. Pharmacologists are involved in the discovery to find a drug for the intended target, and to check for off-target effects. General toxicologists, pharmacokineticists and pathologists are working together to describe the consequences of these effects in animal models. Translational steps are important for the prediction of the safety of the compound in humans. Important safety aspects are carcinogenicity, reproductive toxicity and immunotoxicity. All these areas have an important histopathological component, and high quality reports are essential in the evaluation of these aspects. The webinar will focus on Carcinogenicity testing of human pharmaceuticals, and highlight discussions that are ongoing, especially in relation to the International Conference on Harmonization.

November 5, 201514:30 (2:30 PM) CESTRegister by November 2, 2015

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Speaker: Jan Willem van der LaanChair Safety Working Party (human), European Medicines AgencySenior Assessor Pharmacology-ToxicologyMedicines Evaluation Board, The NetherlandsDr. Jan Willem van der Laan is senior assessor in the Section Pharmacology and Toxicology Assessment at the Medicines Evaluation Board. He contributed to the International Conference on Harmonization from as early 1992 when he became a member of the Expert Working Group on Carcinogenicity Testing (S1). Later on he was member and Regulatory Rapporteur on Immunotoxicity Testing (S8). Now again, he is a member and Regulatory Chair of the new Expert Working Group on Carcinogenicity testing, which started in 2011.

For registration or technical questions, please contact IFSTP at ifstp-hq@verizon.netThis webinar will be available for future viewing on www.ifstp.net

Please visit the IFSTP website at www.ifstp.net to register for the webinar. You must preregister by November 2nd. Space is limited to 100 attendees and is available on a first-come,first-serve basis. Please allow one week for your registration to be processed. Once yourregistration is approved, you will receive an email from the IFSTP office with instructions on how to join the webinar.

Deadline to Register is November 2, 2015

Webinar Registration is Free, but space is limited!

Jointly sponsored by

Nederlandse Vereniging voor Toxicologie (NLSTP), IFSTP and IATP