PPT-Donor Screening Biologic product versus Drug

Universal Stool Bank Patientdirected donor GI IBD IBS GVHD ICI Colitis Potential NonCDI Indications Gupta S Mullish BH and Allegretti JR Am J Gastroenterol 2020 FMT The Evolving Risk Landscape. Ottawa Fertility Centre. The Egg Donation Process. Should I consider treatment with egg donation?. Who are the egg donors?. What are logistics between my cycle and my donor?. What is recipient screening?. and Genomics GmbH. Novel Screening Systems for Tailored Medicine and . Pharmacogenomics. Company Profile: . Celltech. . and. . Genomics. GmbH. Specialised. in . cell-based. . screening. . systems. View . from the Life Sciences . Industry. Moderator: Hans Sauer, Biotechnology Innovation Organization (BIO). Speakers. :. Peter . Cicala. , Celgene. Phil . Makrogiannis. , . Thermo. Fisher Scientific. Quality Director. Blood Systems. Disclosure. I . have no relevant financial relationships . to disclose. .. Learning Objectives. Describe a scenarios that would be reportable as a BPD.. Recognize when patient lookback is required.. “Who are the addicts?”. Screening: Why screen universally?. Drinking and drug use…. are common. often go undetected. can increase risks to safety and health problems . Routine screening for other potential medical problems (e.g. cancer, diabetes, hypertension). Why not for alcohol and drug use?. Donald Jacob, M.D. Medical Director Niagara Frontier Transportation Authority 12 th Annual FTA Drug and Alcohol Conference New Orleans, LA April 2017 Role of the Medical Review Officer Assistant Toni Clay Governing Agencies. Governing agencies . for . processes including donor selection and donor unit processing. U.S. Food and Drug Administration (FDA). Center for Biologics Evaluation and Research (CBER) . PatriciaA.Kassebaum,PaulL.Grimaldi,andKaziAhmedareaffiliatedwithJBSInternational,Inc.,SilverAddresscorrespondenceto:ThomasF.Babor,TheUniversityofConnecticutSchoolofMedicine,263Thewritingofthispaperwas AND . VOLUNTARY BLOOD DONATION CAMPS. . SOURCE OF BLOOD . . Blood Donor . Value Blood Donor as . VIP. Should meet defined Donor Selection criteria . 1. DRUG NAMES. Chemical name. Development name used internally. Biologic drugs too complex to use chemical name. Non-proprietary name (generic name). Combination name for some combination drugs. Proprietary name (brand name). Crohn’s. Disease used for. :. Severe active CD: HBI = >8 CDAI = >300. Inadequate response for tolerance of contraindication to conventional therapies. Chronic active CD with failure to control with immunosuppression. information that will help you understand t Who can be an Egg Donor? An egg donor is a compassionate woman who offers another woman the chance to become a mother. Any woman in good health, between th Clue: . A biologic product with no clinically meaningful differences from its reference product.  . What is… . A biosimilar. A biosimilar is a biological product that:. 1,2. . Is highly similar to the RP notwithstanding minor differences in clinically inactive components; and. Martin . Nemec. , Ph.D.. Monoclonal Antibodies Division (MAD). Biologics . and Genetic Therapies Directorate (BGTD). Health Products and Food Branch (HPFB). Health . Canada. CAPRA Annual Education Day, June 11.