PQRI Workshop on Application of IVIVC in Formulation Development

DECRETO NÚMERO4919DE Hoja No. 2Continuación del Decreto "Por el cual se modifica el Decreto 1610 de 2003".MINISTRO DE LA PROTECCiÓNSOCIALDIEGO PALACIO BE ANCOURTMINISTRA DE TECNOLOGfAS DE LA INFORMACiÓNY LAS COMUNICACIONES(~);pt2dJ~AR A DEL ROSARIO GUERRA DE LA ESPRIELLALA DIRECTORA DEL DEPARTAMENTO ADMINISTRATIVODE LA FUNCiÓN PÚBLICAELlZABETHRODRfGUEZ TAYLOR

10:00 amfda’s experience on IvIvc—generic drugsBarbara M. Davit, Ph.D.U.S. food and drug administration10:30 amcoffee break11:00 am – 1:00 pmbreakout Sessions4 SeSSIonS In PaRallel; one hoUR In dURatIon; IndIvIdUalS can Select 2 SeSSIonSBREAKoUT SESSIon EUse of IvIvc data to Support biowaiverJames E. Polli, Ph.D., University of MarylandTahseen Mirza, Ph.D., U.S. Food and Drug AdministrationBREAKoUT SESSIon FIvIvc and IvIvR for IR dosage formsMaziar Kakhi, Ph.D., U.S. Food and Drug AdministrationDoug F. Smith, M.S., DFS Consulting, LLCBREAKoUT SESSIon Gfocus on mR dosage formsMario A. González, Ph.D., P’Kinetics International, Inc.John Z. Duan, Ph.D., U.S. Food and Drug AdministrationBREAKoUT SESSIon HUntangling the Regulatory knots—the Road map to harmonizedguidances WorldwideTheresa Shepard, Ph.D., MHRASandra Suarez-Sharp, Ph.D., U.S. Food and Drug Administration1:00 pmlunch2:00 pm – 5:30 pmSESSIon IV: wHERE Do wE Go FRoM HERE?MoDERAToRSVinod P. Shah, Ph.D.Pharmaceutical ConsultantAvi Yacobi, Ph.D.Independent Consultant2:00 pmSummary and discussion of break-out Sessions2:00 pmbReakoUt SeSSIon-a2:15 pmbReakoUt SeSSIon -b2:30 pmbReakoUt SeSSIon -c2:45 pmbReakoUt SeSSIon -d3:00 pmbReakoUt SeSSIon -e3:15 pmbReakoUt SeSSIon -f3:30 pmbReakoUt SeSSIon -g3:45 pmbReakoUt SeSSIon -h4:00 pmQuestion and answer Session4:15 pmcoffee break4:30 pm“What is in the future?”Tony DeStefano, Chair, <strong>PQRI</strong> Steering Committee5:00 pmconclusions and next StepsVinod P. Shah, Ph.D., Pharmaceutical ConsultantAvi Yacobi, Ph.D., Independent ConsultantSePtembeR 7, 2012Planning committee members only8:30 am – 4:00 pm<strong>Workshop</strong> evaluation and White Paper construction<strong>PQRI</strong> <strong>Workshop</strong> on Application of IVIVC in Formulation Development 3

<strong>PQRI</strong> mISSIon StatementThe Product Quality Research Institute (<strong>PQRI</strong>) is a non-profit consortiumof organizations working together to generate and share timely, relevant,and impactful information that advances drug product quality anddevelopment.By virtue of its diverse membership, <strong>PQRI</strong> provides a unique forum tofocus critical thinking, conduct research, exchange information, andpropose methodology or guidance to pharmaceutical companies, regulators,and standard setting organizations.<strong>PQRI</strong> membeR oRganIzatIonSAAPSAmerican Association of Pharmaceutical ScientistsCHPAConsumer Healthcare Products AssociationFDA/CDERU.S. Food and Drug Administration, Center for Drug Evaluationand ResearchHCHealth CanadaIPEC-AmericasInternational Pharmaceutical Excipients Council of the AmericasUSPUnited States PharmacopeiaboaRd of dIRectoRSMario L. Rocci, Jr., Ph.D., chairGlenn Van Buskirk, Ph.D., treasurerAnthony DeStefano, Ph.D.Avraham Yacobi, Ph.D.Rachael Roehrig, Ph.D.FDA Helen n. winkle, nakissa Sadrieh, Ph.D., Raj Uppoor, R.Ph., Ph.D.HC Anita DiFrancoIPEC-Americas Dave SchonekerUSP Kevin Hool, Ph.D.venUe and RegIStRatIonThe workshop is being held at the Bethesda north Marriott Hotel andConference Center and reservations may be made by calling ReservationsToll Free: 1-(877)-212-5752 and referring to the <strong>PQRI</strong> <strong>Workshop</strong> onapplication of IvIvc.Hotel reservations can also be made online athttps://resweb.passkey.com/Resweb.do?mode=welcome_ei_new&eventId=8702506&utm_source=2644099&utm_medium=email&utm_campaign=11292436 and enter your check-in and check-out date link tomake sure you get the discounted rate of $179 per night for single anddouble occupancy.Registration for the workshop can be made by going to the SignMeUpwebsite at www.signmeup.com/82155For additional information, please contact Vicki Penn atPennv@pqri.org or by phone at (703) 248-4719.Bethesda north Marriott'5701 Marinelli RoadBethesda, MD 20852(301) 822-9200Please register for the workshop on Sign Me Up atwww.signmeup.com/82155<strong>PQRI</strong> SteeRIng commIttee(RePReSentatIve and alteRnateS)Anthony DeStefano, Ph.D., chairRachael Roehrig, Ph.D., vice chairAAPS Lynn Van Campen, Ph.D., John Lisack, Jr., CAE, Stacey May, M.A.CHPA John Punzi, Ph.D.<strong>PQRI</strong> <strong>Workshop</strong> on Application of IVIVC in Formulation Development4

product Quality research Institute (pQrI)2107 Wilson Blvd., suite 700Arlington, VA 22201Vicki pennpQrI Executive secretarypennV@pqri.orgph: (703) 248-4719Fx: (703) 525-7136www.pqri.org