http://www.pda.org/MainMenuCategory/GlobalEventCalendarandRegistration/ClinicalTrials.aspxThe fastest growing sector in the pharmaceutical industry is biologics. “Quality by Design (QbD)” and “The process is the product” have become long-time mottos for the regulators and companies developing new medicinal products also in this segment of the industry. Increased use of a wide variety of new technologies and expression systems makes GMP practices even more difficult to apply. Earlier stages of development and advancement of the product lifecycle through clinical stages to marketing can cause confusion about the regulatory status, since three branches of the Food and Drug Administration (FDA) are involved: the Center for Biologics Evaluation and Research (CBER); the Center for Drug Evaluation and Research (CDER); and the Office of Regulatory Affairs (ORA). In addition, compliance with international regulatory agencies is increasingly becoming a challenge.Copyright 2008en-usSun, 14 Mar 2010 23:25:43 GMT1http://www.pda.org/MainMenuCategory/GlobalEventCalendarandRegistration/ClinicalTrials/Speaker-Biographies.aspxN/AMon, 20 Oct 2008 14:42:45 GMThttp://www.pda.org/MainMenuCategory/GlobalEventCalendarandRegistration/ClinicalTrials/HyattCambridge.aspxN/AWed, 24 Sep 2008 18:33:43 GMThttp://www.pda.org/MainMenuCategory/GlobalEventCalendarandRegistration/ClinicalTrials/AgendaPDF.aspxN/AMon, 08 Sep 2008 15:29:42 GMThttp://www.pda.org/MainMenuCategory/GlobalEventCalendarandRegistration/ClinicalTrials/RegistrationFees.aspxN/AMon, 08 Sep 2008 15:29:48 GMThttp://www.pda.org/MainMenuCategory/GlobalEventCalendarandRegistration/ClinicalTrials/NetworkingOpportunities.aspxN/AMon, 08 Sep 2008 15:29:54 GMThttp://www.pda.org/MainMenuCategory/GlobalEventCalendarandRegistration/ClinicalTrials/ExhibitorsandSponsorships.aspxN/AThu, 18 Sep 2008 22:19:42 GMThttp://www.pda.org/MainMenuCategory/GlobalEventCalendarandRegistration/ClinicalTrials/ExhibitorsandSponsorships/HyaluronContractManufacturing.aspxN/AThu, 18 Sep 2008 22:24:24 GMThttp://www.pda.org/MainMenuCategory/GlobalEventCalendarandRegistration/ClinicalTrials/ExhibitorsandSponsorships/IsogenLLC.aspxN/AThu, 18 Sep 2008 22:25:44 GMThttp://www.pda.org/MainMenuCategory/GlobalEventCalendarandRegistration/ClinicalTrials/ExhibitorsandSponsorships/Lyophilization-Technology-Inc-.aspxN/AThu, 23 Oct 2008 08:24:17 GMThttp://www.pda.org/MainMenuCategory/GlobalEventCalendarandRegistration/ClinicalTrials/ExhibitorsandSponsorships/SartoriusStedimNorthAmericaInc.aspxN/AThu, 18 Sep 2008 22:26:35 GMThttp://www.pda.org/MainMenuCategory/GlobalEventCalendarandRegistration/ClinicalTrials/ExhibitorsandSponsorships/SensitechInc.aspxN/AThu, 18 Sep 2008 22:27:44 GMThttp://www.pda.org/MainMenuCategory/GlobalEventCalendarandRegistration/ClinicalTrials/ExhibitorsandSponsorships/SL-Pharma-Labs-Inc--.aspxN/AThu, 16 Oct 2008 10:15:36 GMThttp://www.pda.org/MainMenuCategory/GlobalEventCalendarandRegistration/ClinicalTrials/ExhibitorsandSponsorships/08pdaderegspnscontract.aspxN/AThu, 10 Jul 2008 12:53:15 GMThttp://www.pda.org/MainMenuCategory/GlobalEventCalendarandRegistration/ClinicalTrials/ExhibitorsandSponsorships/08pdaderegcompprod.aspxN/AThu, 18 Sep 2008 16:57:08 GMThttp://www.pda.org/MainMenuCategory/GlobalEventCalendarandRegistration/ClinicalTrials/ProgramCommittee.aspxN/AMon, 08 Sep 2008 15:30:06 GMThttp://www.pda.org/MainMenuCategory/GlobalEventCalendarandRegistration/ClinicalTrials/Venue.aspxN/AMon, 08 Sep 2008 15:30:19 GMThttp://www.pda.org/MainMenuCategory/GlobalEventCalendarandRegistration/ClinicalTrials/ContinuingEducationCredits.aspxN/AMon, 08 Sep 2008 15:30:25 GMThttp://www.pda.org/MainMenuCategory/GlobalEventCalendarandRegistration/ClinicalTrials/RecommendedReading.aspxN/AMon, 08 Sep 2008 15:30:31 GMThttp://www.pda.org/MainMenuCategory/GlobalEventCalendarandRegistration/ClinicalTrials/08clinicaltrialsbrochure.aspxN/AThu, 18 Sep 2008 16:49:50 GMThttp://www.pda.org/MainMenuCategory/GlobalEventCalendarandRegistration/ClinicalTrials/Banner.aspxN/AThu, 18 Sep 2008 21:56:57 GMThttp://www.pda.org/MainMenuCategory/GlobalEventCalendarandRegistration/ClinicalTrials/HyaluronContractManufacturingTourOpenHouse.aspxN/AMon, 08 Sep 2008 16:04:21 GMT