10:00 amfda’s experience <strong>on</strong> IvIvc—generic drugsBarbara M. Davit, Ph.D.U.S. food and drug adm<strong>in</strong>istrati<strong>on</strong>10:30 amc<strong>of</strong>fee break11:00 am – 1:00 pmbreakout Sessi<strong>on</strong>s4 SeSSI<strong>on</strong>S In PaRallel; <strong>on</strong>e hoUR In dURatI<strong>on</strong>; IndIvIdUalS can Select 2 SeSSI<strong>on</strong>SBREAKoUT SESSI<strong>on</strong> EUse <strong>of</strong> IvIvc data to Support biowaiverJames E. Polli, Ph.D., University <strong>of</strong> MarylandTahseen Mirza, Ph.D., U.S. Food and Drug Adm<strong>in</strong>istrati<strong>on</strong>BREAKoUT SESSI<strong>on</strong> FIvIvc and IvIvR for IR dosage formsMaziar Kakhi, Ph.D., U.S. Food and Drug Adm<strong>in</strong>istrati<strong>on</strong>Doug F. Smith, M.S., DFS C<strong>on</strong>sult<strong>in</strong>g, LLCBREAKoUT SESSI<strong>on</strong> Gfocus <strong>on</strong> mR dosage formsMario A. G<strong>on</strong>zález, Ph.D., P’K<strong>in</strong>etics Internati<strong>on</strong>al, Inc.John Z. Duan, Ph.D., U.S. Food and Drug Adm<strong>in</strong>istrati<strong>on</strong>BREAKoUT SESSI<strong>on</strong> HUntangl<strong>in</strong>g the Regulatory knots—the Road map to harm<strong>on</strong>izedguidances WorldwideTheresa Shepard, Ph.D., MHRASandra Suarez-Sharp, Ph.D., U.S. Food and Drug Adm<strong>in</strong>istrati<strong>on</strong>1:00 pmlunch2:00 pm – 5:30 pmSESSI<strong>on</strong> IV: wHERE Do wE Go FRoM HERE?MoDERAToRSV<strong>in</strong>od P. Shah, Ph.D.Pharmaceutical C<strong>on</strong>sultantAvi Yacobi, Ph.D.Independent C<strong>on</strong>sultant2:00 pmSummary and discussi<strong>on</strong> <strong>of</strong> break-out Sessi<strong>on</strong>s2:00 pmbReakoUt SeSSI<strong>on</strong>-a2:15 pmbReakoUt SeSSI<strong>on</strong> -b2:30 pmbReakoUt SeSSI<strong>on</strong> -c2:45 pmbReakoUt SeSSI<strong>on</strong> -d3:00 pmbReakoUt SeSSI<strong>on</strong> -e3:15 pmbReakoUt SeSSI<strong>on</strong> -f3:30 pmbReakoUt SeSSI<strong>on</strong> -g3:45 pmbReakoUt SeSSI<strong>on</strong> -h4:00 pmQuesti<strong>on</strong> and answer Sessi<strong>on</strong>4:15 pmc<strong>of</strong>fee break4:30 pm“What is <strong>in</strong> the future?”T<strong>on</strong>y DeStefano, Chair, <str<strong>on</strong>g>PQRI</str<strong>on</strong>g> Steer<strong>in</strong>g Committee5:00 pmc<strong>on</strong>clusi<strong>on</strong>s and next StepsV<strong>in</strong>od P. Shah, Ph.D., Pharmaceutical C<strong>on</strong>sultantAvi Yacobi, Ph.D., Independent C<strong>on</strong>sultantSePtembeR 7, 2012Plann<strong>in</strong>g committee members <strong>on</strong>ly8:30 am – 4:00 pm<str<strong>on</strong>g>Workshop</str<strong>on</strong>g> evaluati<strong>on</strong> and White Paper c<strong>on</strong>structi<strong>on</strong><str<strong>on</strong>g>PQRI</str<strong>on</strong>g> <str<strong>on</strong>g>Workshop</str<strong>on</strong>g> <strong>on</strong> Applicati<strong>on</strong> <strong>of</strong> <strong>IVIVC</strong> <strong>in</strong> Formulati<strong>on</strong> <strong>Development</strong> 3
<str<strong>on</strong>g>PQRI</str<strong>on</strong>g> mISSI<strong>on</strong> StatementThe Product Quality Research Institute (<str<strong>on</strong>g>PQRI</str<strong>on</strong>g>) is a n<strong>on</strong>-pr<strong>of</strong>it c<strong>on</strong>sortium<strong>of</strong> organizati<strong>on</strong>s work<strong>in</strong>g together to generate and share timely, relevant,and impactful <strong>in</strong>formati<strong>on</strong> that advances drug product quality anddevelopment.By virtue <strong>of</strong> its diverse membership, <str<strong>on</strong>g>PQRI</str<strong>on</strong>g> provides a unique forum t<strong>of</strong>ocus critical th<strong>in</strong>k<strong>in</strong>g, c<strong>on</strong>duct research, exchange <strong>in</strong>formati<strong>on</strong>, andpropose methodology or guidance to pharmaceutical companies, regulators,and standard sett<strong>in</strong>g organizati<strong>on</strong>s.<str<strong>on</strong>g>PQRI</str<strong>on</strong>g> membeR oRganIzatI<strong>on</strong>SAAPSAmerican Associati<strong>on</strong> <strong>of</strong> Pharmaceutical ScientistsCHPAC<strong>on</strong>sumer Healthcare Products Associati<strong>on</strong>FDA/CDERU.S. Food and Drug Adm<strong>in</strong>istrati<strong>on</strong>, Center for Drug Evaluati<strong>on</strong>and ResearchHCHealth CanadaIPEC-AmericasInternati<strong>on</strong>al Pharmaceutical Excipients Council <strong>of</strong> the AmericasUSPUnited States PharmacopeiaboaRd <strong>of</strong> dIRectoRSMario L. Rocci, Jr., Ph.D., chairGlenn Van Buskirk, Ph.D., treasurerAnth<strong>on</strong>y DeStefano, Ph.D.Avraham Yacobi, Ph.D.Rachael Roehrig, Ph.D.FDA Helen n. w<strong>in</strong>kle, nakissa Sadrieh, Ph.D., Raj Uppoor, R.Ph., Ph.D.HC Anita DiFrancoIPEC-Americas Dave Sch<strong>on</strong>ekerUSP Kev<strong>in</strong> Hool, Ph.D.venUe and RegIStRatI<strong>on</strong>The workshop is be<strong>in</strong>g held at the Bethesda north Marriott Hotel andC<strong>on</strong>ference Center and reservati<strong>on</strong>s may be made by call<strong>in</strong>g Reservati<strong>on</strong>sToll Free: 1-(877)-212-5752 and referr<strong>in</strong>g to the <str<strong>on</strong>g>PQRI</str<strong>on</strong>g> <str<strong>on</strong>g>Workshop</str<strong>on</strong>g> <strong>on</strong>applicati<strong>on</strong> <strong>of</strong> IvIvc.Hotel reservati<strong>on</strong>s can also be made <strong>on</strong>l<strong>in</strong>e 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-<strong>in</strong> and check-out date l<strong>in</strong>k tomake sure you get the discounted rate <strong>of</strong> $179 per night for s<strong>in</strong>gle anddouble occupancy.Registrati<strong>on</strong> for the workshop can be made by go<strong>in</strong>g to the SignMeUpwebsite at www.signmeup.com/82155For additi<strong>on</strong>al <strong>in</strong>formati<strong>on</strong>, please c<strong>on</strong>tact Vicki Penn atPennv@pqri.org or by ph<strong>on</strong>e at (703) 248-4719.Bethesda north Marriott'5701 Mar<strong>in</strong>elli RoadBethesda, MD 20852(301) 822-9200Please register for the workshop <strong>on</strong> Sign Me Up atwww.signmeup.com/82155<str<strong>on</strong>g>PQRI</str<strong>on</strong>g> SteeRIng commIttee(RePReSentatIve and alteRnateS)Anth<strong>on</strong>y 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.<str<strong>on</strong>g>PQRI</str<strong>on</strong>g> <str<strong>on</strong>g>Workshop</str<strong>on</strong>g> <strong>on</strong> Applicati<strong>on</strong> <strong>of</strong> <strong>IVIVC</strong> <strong>in</strong> Formulati<strong>on</strong> <strong>Development</strong>4