Joint DIA/AEMPS Statistics Workshop Barcelona 2014

  • Conference Call
  • This Sta­tis­tics Work­shop is jointly organ­ised by the Agen­cia Española de Medica­men­tos y Pro­duc­tos San­i­tar­ios (AEMPS) and the Drug Infor­ma­tion Asso­ci­a­tion (DIA) and will be held in Barcelona, Spain at the Tryp Barcelona Apolo Hotel on Novem­ber 10 – 11, 2014.

    Overview

    Life­cy­cle man­age­ment is a widely accepted con­cept for devel­op­ment and mar­ket­ing of med­i­cines. At each step of this process, pre– and post-​licensing, sta­tis­ti­cians work to develop meth­ods that can improve effi­ciency and can enhance deci­sion mak­ing through opti­mal study design, analy­sis and inference.

    The meet­ing aims to dis­cuss the lat­est devel­op­ments in sta­tis­ti­cal method­ol­ogy and deci­sion mak­ing in exploratory devel­op­ment, con­fir­ma­tory devel­op­ment, licens­ing deci­sions and man­age­ment of ben­e­fits and risks post-​licensing. The dis­cus­sions will con­sider not only the meth­ods them­selves, but how best to inte­grate meth­ods for use in a reg­u­la­tory con­text. Beyond this, the meet­ing seeks to ask whether there are advances in the col­lec­tion and under­stand­ing of real world data that can inform and improve the design of con­fir­ma­tory clin­i­cal trials.

    Fea­tured Topics

    • Lat­est news on emerg­ing reg­u­la­tory guid­ance doc­u­ments for clin­i­cal trial methodology
    • Clin­i­cal Trial Trans­parency – prac­ti­cal chal­lenges ahead for statisticians
    • Har­mon­is­ing spon­sor and reg­u­la­tor decision-​making across the life-​cycle, from dose-​finding through benefit-​risk and beyond; under­stand­ing hur­dles and opti­mis­ing meth­ods with a focus on Bayesian Sta­tis­tics and quan­ti­ta­tive Ben­e­fit Risk
    • Ther­a­peu­tic area spe­cial; a focus on bio­log­i­cal medicines
    • Clin­i­cal Prac­tice Research Datalink tutorial
    • Incor­po­rat­ing real world data into drug devel­op­ment, licens­ing, re-​imbursement and prescribing
    • Risk-​based monitoring
    • Increas­ing the breadth of spon­sor /​reg­u­la­tor inter­ac­tions on methodology

    Who Should Attend

    Pro­fes­sion­als with an inter­est in the appli­ca­tion of, and research into, sta­tis­tics in the drug devel­op­ment process from the phar­ma­ceu­ti­cal indus­try, acad­e­mia, reg­u­la­tory and gov­ern­men­tal agen­cies, as well as con­tract research organisations.

    Con­tin­u­ing Education

    DIA meet­ings and train­ing courses are gen­er­ally approved by the Com­mis­sion for Pro­fes­sional Devel­op­ment (CPD) of the Swiss Asso­ci­a­tion of Phar­ma­ceu­ti­cal Pro­fes­sion­als (SwAPP) and the Swiss Soci­ety of Phar­ma­ceu­ti­cal Med­i­cine (SGPM) and will be hon­oured with cred­its for phar­ma­ceu­ti­cal med­i­cine. All par­tic­i­pants are eli­gi­ble for these cred­its and cer­tifi­cates are available.

    Organ­is­ing Board

    Pro­gramme Co-​Chairs

    • Fer­ran Tor­res – Sci­en­tific Direc­tor, Bio­sta­tis­tics and Data Man­age­ment Core Facil­ity, IDIBAPS – Hos­pi­tal Clinic of Barcelona. Asso­ciate Pro­fes­sor, Bio­sta­tis­tics Unit, Fac­ulty of Med­i­cine, Autonomous Uni­ver­sity of Barcelona. AEMPS Sta­tis­ti­cal Con­sul­tant. Spain
    • Beat­riz Seoane – Expert Sta­tis­ti­cian, Clin­i­cal Sta­tis­tics Depart­ment, Almi­rall, Spain

    Sci­en­tific Advisor

    • Michael Bran­son – Global Head Full Devel­op­ment Bio­sta­tis­tics, Oncol­ogy Busi­ness Unit, Novar­tis Pharma AG, Switzerland

    Pro­gramme Committee

    • Nor­bert Benda – Head of Bio­sta­tis­tics and Spe­cial Phar­ma­co­ki­net­ics, Fed­eral Insti­tute for Drugs and Med­ical Devices (BfArM), Germany
    • Hans-​Ulrich Burger – Senior Direc­tor of Bio­sta­tis­tics, F. Hoffmann-​La Roche AG, Switzerland
    • William Mal­becq – Exec­u­tive Direc­tor Bio­sta­tis­tics, MSD Europe, Brus­sels, Belgium
    • Tim Friede – Pro­fes­sor of Bio­sta­tis­tics, Chair, Depart­ment of Med­ical Sta­tis­tics, Uni­ver­sity Med­ical Cen­tre Göt­tin­gen, Germany
    • Geert Ver­beke – Pro­fes­sor of Bio­sta­tis­tics, Depart­ment of Pub­lic Health and Pri­mary Care, KU Leu­ven, Belgium
    starting: ending: 11.11.2014 Location: , Category:

    Timeline

    Conference START 11.11.2014 END

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