Thanks to all of our speakers, instructors, and members of our advisory committee for their valuable contributions toward
our program.
| Advisory Board |
|
| Ronald Alkana, PhD |
Associate Dean Graduate Affairs, USC School of Pharmacy |
| Kathy Allen, PhD |
Professor of Clinical, USC Marshall School of Business |
| Dennis Atkinson, MSc |
Research Advancement Director, USC Office of of Vice Porvost |
| Mel Baron, PhD |
Associate Professor of Clinical Pharmacy, USC School of Pharmacy |
| Catherine Beath, MBA |
Vice President, Quality & Regulatory Affairs, Ethicon, Inc. |
| Dana Bell, PhD |
Regualtory Affairs Consultant |
| John Bentivoglio, JD |
Skadden, Arps, Slate, Meagher & Flom, LLP |
| Gilbert J. Burckart, PharmD |
Associate Director for Regulatory Policy, CDER, U.S. FDA |
| Rosemarie Christopher, MS |
Founder, MedExec International |
| Enrique Cadenas, PhD |
Professor Assicate Dean for Research Affairs, USC School of Pharmacy |
| Gary Charbonneau, MSRS |
Global Regulatory Affairs & Safety Operations Department, Allergan, Inc. |
| Roger Clemens, DrPh, CNS, FACN |
Adjunct Porfessor, USC School of Pharmacy, Regulatory Science Program |
| Karen Church, PhD, RAC |
Vice President, Regulatory Affairs, OCERA Therapeutics, Inc. |
| MaryEllen Cosenza, PhD |
Executive Driect of Regulatory Affairs & Safety, Amgen, Inc. |
| Alonza Cruse, MS |
Los Angeles District Drector, FDA Office of Regulatory Affairs |
| Richard DeRisio MS |
Vice President Regulatory Affairs, Abbott Medical Optics, Inc. |
| MaryAnn Foote, PhD |
Freelance Writer, Editor & Teacher |
| Patricia Garvey, PhD |
Regulatory Consultant |
| Mary Gordon |
Conference Director, UBM Cannon LLC/Cannon Communications LLC |
| Michael Hamrell, PhD |
President, Moriah Consultants |
| Sharon Higgins, MSc |
Executive Driector, Irish Meidcal Device Association, Dublin, Ireland |
| Lorry W. Huffman, RAC, MT |
Dr. Director Regulatory Affairs, Volcano Corportion |
| Doug Hunt |
Vice President, Global Regulatory Affairs, Baxter Pharmaceuticals |
| Michael Jamieson, DRSc |
Associate Director, USC Regulatory Science Program; President, Insource Innovations Inc., Canada |
| Gerald Loeb, MD |
USC Professor of Biomedical Engineering & Director Medical Device Development, Viterbi School of Engineering |
| Larry Lesko, PhD |
Director, Office of Clinical Pharmacology, U.S. FDA |
| Michael McGuffin |
President, American Herbal Products Association |
| Stephanie Mensh, MPA |
Vice President Reimbursement Polidy, StrokeSurvivor |
| Elaine Messa, BA |
Director of Medical Device Quality Systems & Compliance Practice, Becker & Associates Consulting., Inc. |
| Michael Morton, MA |
Senior Director Global Regulatory Affairs, Medtronic, Inc. |
| Virginia Perry, RAC, CQ |
Founder & Partner, Perry-D'Amico & Associates |
| Susan Pignataro, MBA/MAS |
Sr. Director, Customer Experience Solutions Group, Cisco Systems |
| Enid Rokaw, MS |
Instructor, USC Regulatory Science Program; President EBR Consulting Group |
| Susan Rose, PhD |
Exective Director, USC Office for Protection of Research Subjects |
| Judy Rosebloom |
Founder & Preseident, JR Associates |
| Javad Seyedzadeh, MS |
Senior Vice President, Globla QA & RA, GAMBRO |
| Nancy Singer, JD |
President, Compliance-Alliance, LLC |
| Helene Spencer, BS |
President, ClinReg Consulting Services |
| Stephen Ubl |
President & CEO, AdvaMed |
| |
|
| Course Speakers |
|
| Abernathy, R. Darrell |
Contractor, Non-Government, FDA DHHS |
| Abraquez-Delacruz, Prosy |
Regional Administrator, Food Safety Section-South, California Department of Health Services Food and Drug Branch |
| Adams, Gerrie |
Professor, Department of Physical Sciences, Chapman University |
| Adkins, Gary |
Founder, Executive Director, Diversity Solutions |
| Adomian, Susan |
Clinical Manager, SANOFI, Serono |
| Ahmed, Ruhi, PhD |
Manager, Regulatory Affairs, BioMarin Pharmaceutical Inc. |
| Albiani, Roy |
Global Director, Brand Integrity, LifeScan, J&J Company |
| Alkana, Linda |
Undergrad Advisor, Hisotry Dept., Dept of International Studies, CSULB |
| Alkana, Ron, PhD |
Prof. Dept. Pharmacology & Pharmaceutical Sciences, USC School of Pharmacy |
| Allen, Kathy |
Prof. of Clinical/entrepreneurial Studies, USC Marshall School of Business |
| Alley-Zarakedes, Lisa |
VP Food Technology, ET Horn |
| Anderson, John |
Director, Corporate Strategic Planning, Beckman Coulter Inc. |
| Anderson, William |
Associate Director, Biostatistics/Clinical Data Management, Edward Lifesciences LLC |
| Antonio, Duarte |
IntraLase Corp. |
| Apfelberg, Andrew M, Esq. |
Rutter Hobbs & Davidoff, Incorporated |
| Ardalan, Christopher |
Ardalan and Associates |
| Asarch, Ken |
VP, Clinical and Regulatory Affairs and Quality Systems, Careside Inc. |
| Bain, Susan |
Consumer Safety Officer, FDA |
| Baker, Dennis |
Deputy Commissioner for Regulatory Affairs, FDA |
| Baker, Don |
VP II, Quality, Baxter Healthcare Corp. |
| Baron, Mel, PhD |
Associate Professor of Clinical Pharmacy, Department of Pharmacy |
| Baron, Ross, PhD |
Professor of Religion, Brigham Young University-Idaho |
| Beath, Catherine |
WW VP QA/RA, Ethicon, Inc. |
| Beatty, Carol |
Queen's University, School of Business |
| Bell, Dana, PhD |
Regulatory Affairs Consultant |
| Bentivoglio, John |
Skadden, Arps, Slate, Meagher & Flom LLP |
| Berg, Jim |
ET Horn Company |
| Bergan, John J., RAC |
Manager of Regulatory Affairs/QA, CMC Specialist, Amgen, Inc |
| Berger, Kenneth |
VP, Quality Assurance & Regulatory Affairs, Irvine Pharmaceutical Services |
| Bernal, David, PharmD |
Associate Director of RA, Genentech, Inc |
| Bernstein, David |
Vice President, CATO Research, Ltd. |
| Bernstein, Ilisa |
FDA DHHS |
| Besseling, Nicolaas C. |
Principal, Medical Instrumentation, BesTech Consulting Services |
| Bhasin, Simon |
Baxter Bioscience |
| Bidlack, Wayne, PhD |
Dept. Human Nutrition & Food Service, CS polytechnic University, Pomona |
| Bills, Edwin |
Principal Consultant, Bilanx Consulting LLC |
| Blasco, Michael |
MS, RAC, Reg Affairs Manager, Gen-Probe Incorporated |
| Bobka, Marlene |
VP, FOI Services, Inc. |
| Bolton, Sanford, PhD |
Visiting Professor, University of Arizona. |
| Perkins, Bonnie |
Senior Regulatory Affairs Specialist , Medtronic Vascular |
| Booth, Thomas, PhD |
USC Viterbi School of Engineering |
| Borrelli, Joseph |
Borrelli & Associates |
| Botero-Omary, Maria, PhD |
Assistant Professor, Food Science & Human Nutrition, California State Polytechnic University |
| Bovenkamp, Diane |
Director of Science Information & Programs, The Foundaton Fighting Blindness |
| Bozeman, Mark H. |
Attorney, Partner, Hogan & Hartson, LLP |
| Brandon, George |
Partnership Development Leader, Morris, Plich & Purdy, LLP |
| Broad, John |
NAMSA |
| Bruhn, Christine |
Outcomes Liaison, Lilly |
| Buckley, Paul, B.S. |
USC Alfred E. Mann Institute |
| Burckart, Gilbert |
Assc.Director Reg Policy, Office Clinical Pharmacy, CDER, US FDA |
| Calicchia, Melissa |
Technical Direct, Food Safety Solutions, Inc. |
| Campbell, Jeanette |
PAI Air Quality Laboratory |
| Camps, Julio, MD |
Amgen, Inc. |
| Castagnaro, Lee Carole |
GCP Specialist, Drumbeat Dimensions |
| Carrier, Larry |
Medtronic Vascular |
| Chacko, Jimmy |
Regulatory Affairs Manager, Lenstec, Inc |
| Chamberlain, Mark |
VP, Operations, BS, Bioness Inc. |
| Chan, Tony |
Adjunct Instructor, USC Regulatory Science Program |
| Chang, Thomas |
Seltzer Chemicals |
| Charbonneau, Gary |
Global Reg Affairs and Safety, Operations Department Allergan, Inc. |
| Chignon, Thierry |
Matignon Technologies |
| Chirnomas, Morton |
Business Development & Licensing Assoc., USC Steven Institute for Innovation |
| Choy, Margaret |
VP, Regulatory Affairs, Anchen Pharmaceuticals, Inc. |
| Christ, Oliver P. |
General Manager Health Care, PROSYSTEM AG |
| Christopher, Rosemarie |
Principal. MedExec International |
| Church, Karen K., PhD, RAC |
V.P. Reg Affairs, Ocera Therapeutics, Inc. |
| Citron, Paul |
VP, Medtronic, Inc. |
| Cleavenger, Becky |
Senior Director, Global Advertising and Promotion Center of Excellence, Baxter Healthcare Corp. |
| Clemens, Roger A. |
Director, Analytical Research & Services in Complementary Therapeutics, USC School of Pharmacy |
| Collins, Kenneth A. |
Vice President, RA, QA & CA, Alsius Corporation |
| Cosenza, Mary Ellen, PhD |
Executive Director of Reg Affairs, Amgen, Inc. |
| Coughlin, James R., PhD |
President, Coughlin & Associates |
| Craft, Ginger |
President, ISO Comp, Inc. |
| Jeffrey Craft, Esq. |
Of Counsel, Arent Fox, Los Angeles; Directo fo IP, ABS Materials, Ohio |
| Cruse, Alonza |
District Director, Los Angeles, FDA Office of Regulatory Affairs |
| Cruz, Martha L. |
DVM, Dphil |
| Cullman, Louis "Chip" |
K&L Gates, LLP |
| Cupo-Abbott, Jennifer |
Asst. Professor of Clinical, Dept., University Hospital Pharmacy |
| Currey, Brain S. |
O'Melveny & Myers LLP |
| Dahl, Rebecca |
IRB, CHLA |
| Dahl, Russell, PhD |
Burnham Institute for Medical Research |
| Dalpan, Gerald |
Supervisory Medical, FDA DHHS/FDA/CDER/OSE |
| Daviels, AnnaMarie |
VP of Clinical Research, Advanced Bionics |
| D'Argenio, David |
Professor/Chairman, USC Biomedical Engineering |
| Das, Rupa |
Director of Quality & Reg Compliance, BI Nutraceuticals |
| Davies, Audra |
Manager, Nutrition Science & Services; Nutrition R&D Nutrilite |
| Davies, Daryl L., PhD |
Associate Professor of Clinical Pharmacy, USC School of Pharmacy |
| DeBré, Kevin D., Esq. |
Stubbs Alderton & Markiles, LLP |
| Delgra, Jr., Cecilio Galvez, M.D. |
Associate Medical Director, Global Safety, Amgen, Inc. |
| DeRisio, Richard J. |
Divisional VP Global Reg Affairs, Abbott Medical Optics, Inc. |
| Desai, Shetal, PharmD |
Asst Prof., USC School of Pharmacyt, Norris Cancer Hospital |
| Devos, Ann |
GCP Manager, Innogenetics N.V. |
| Dhuwalia, Jack |
President, JD Consulting |
| Dishon, Michelle |
Watson Pharmaceuticals |
| Doan, Chau, PharmD |
Manager, Drug Safety Dept., Watson Pharmaceuticals |
| Donato, Brian, Esq. |
Hyman, Phelps, & McNamara, P.C. |
| Donlon, Jerome, M.D., Ph.D. |
Deputy Director of OCBQ, FDA CBER/OCBQ |
| Archer, Doug |
|
| Dzanis, David |
Diplomate, American College of Veterinary Nutrition, Dzanis Consulting & Collaborations |
| Dziewanowska, Zofia |
Ligand |
| Ed, Bills |
Bilanx Consulting, LLC |
| Elisas, III, Chester G. |
Sr. Manager, Global Reg Affairs & Safety, Amgen, Inc. |
| Elnatan, Andrew |
Regulatory Affairs Dept., Amgen Inc |
| Enany, Ahmed. A. |
Founder and President, Southern California Biomedical Council (SCBC/SoCalBio) |
| Epstein, Lilac |
Senior Regulatory Associate |
| Ereshefsky, Larry, PharmD, FCCP, BCPP |
California Clinical Trials, Exec VP, Chief Scientifc Officer |
| Ertl, Farouz |
Executive Vice President, Technical and Regulatory Affairs |
| Farin, Heinrich, MD |
Chief Scientific Officer, Catalyst Pharmaceuticals |
| Fisher, Carlos, Esq. |
Stout Uxa Buyan & Mullins, LLP |
| Fleitman, Jeff, PhD |
Director, Pharmaceutical Analysis, Allergan |
| Flick, Jr., George J. |
University Distinguished Professor, Food Science & Technology Dept., Virginia Tech (0418) |
| Foote, Mary Ann, PhD |
Amgen Inc. |
| Frackiewicz, Edyta, PharmD |
Senior Research Scientist |
| Fulle, Hans-Jurgen |
Regulatory Affairs Manager, Central Corp RA/Development, RR1/RC Altana Pharma AG |
| Gaffaney, Bernard A. |
Senior Counsel, Corporate, Pioneer North America, Inc. |
| Gallagher, Kesley |
Senior Reg Affairs Specialist, Advanced Medical Optics, Inc. |
| Gareeb, Alexander |
Attorney, Sedwick, Detert, Moran and Arnold LLP |
| Garg, Aditya |
Director of TEL/DL, USC School of Pharmacy |
| Garvey, Patricia |
VP, Regulatory |
| Gaynon, Paul |
Professor, Pediatrics/Children's Hospital, Keck School of Medicine |
| Geigert, John, PhD |
President, BioPharmaceutical Quality Solutions |
| Gibson, Thomas |
Hyman, Phelps, & McNamara, P.C. |
| Giese, Ferdinand |
Manager, Global Marketing Information, Allergan, Inc. |
| Giffin, Suzana, PharmD |
Exec. Dir. Medical Information, Amgen, Inc. |
| Glasscock, Brad, PharmD |
Manager, Regulatory Affairs, Amgen, Inc. |
| Glucroft, Joel |
Glucroft & Associates |
| Gokhale, Mamata, PhD |
Associate Director, Asia and Latin America Clinical Development Operations, Amgen, Inc. |
| Gracon, Stephen |
Senior Director, Global RA, Baxter Bioscience |
| Gregory, Paul |
Pre-Clinical Research Manager, Boston Scientific |
| Grubs, Barry W. |
Program Coordinator, USC HSC Institutional Board |
| Gryziewicz, Lewis |
Director, Global Regulatory Affairs, Allergan |
| Gukasyan, Hovhannes, PhD |
Worldwide Pharmaceutical Sciences, Research, Science and Technology, Formulations, Pfizer Global R&D, La Holla Laboratories |
| Gusev, Vlad |
Amgen, Inc. |
| Haggerty, Kerry |
Associate Director Global Safety - International Compliance, Amgen, Inc |
| Hamblet, Brian |
Burke, Williams & Sorensen |
| Hammerle, Ron |
Consultant, Advanced Educational Corporation |
| Hampton, Scott M. |
CAN DO MEDICAL,Inc. |
| Hamrell, Michael, PhD |
President, Moriah Consultants |
| Hans, Al |
Allen Hans and Associates, Inc |
| Hardy, Mary, M.D. |
Medical Director, Integrative Medicine, Cedars-Sinai Medical Center |
| Hartley, Linda |
FDA |
| Harvey, Phillip W., PhD, FACN |
Chief Science Officer, National Nutritional Foods Association |
| Harvey-Allchurch, Martin |
Head of Executive Support, European Medicines Agency |
| Hatsis, Diana |
R.N. Clinical Research Associate, Center for Clinical Research |
| Higgins, Sharon |
Executive Director, Irish Medical Device Asso Confederation House |
| Hilferty, James |
Manager, Regulatory Services Operations, Liquent Thomson Reuters |
| Himmel, Martin |
FDA CDR, ORM, CDER |
| Hirata, Vivian |
Medtronic , Inc. |
| Hoegi, Julie, M.D. |
Manager, Drug Safety Dept., Watson Laboratories, Inc. |
| Hoffman, Tania |
Regulatory Affairs Specialist, Glumetrics |
| Hori, Mas |
California Department of Health |
| Huffman, Lorry W., RAC, MT(ASCP) |
Sr.Director, Volcano Corp. |
| Hull, Richard |
Dr. Dri Innovation Advancement & Bus. Development, USC Stevens Institute for Innovation |
| Hunt, Doug |
VP Global Regulatory Affairs, Baxter Pharmeuticals |
| Hunter, Robert |
Medical Info Manager, Amgen |
| Hurtado, Kathleen |
President, CEO, Health Research Association, Inc., Keck School of Medicine |
| Hussain, Iqbal |
Amgen, Inc. |
| Hutchinson, Ian |
Professor of Pharmacy, USC Clinical Pharmacy & Econ & Policy |
| Isaacs, Jeanne, B.S. |
Allergan, Inc. |
| Jacob, Mary, PhD, RD |
Professor, Dept. of Family & Consumer Sciences, California State University, Long Beach |
| Jacobs, Pat |
Advanced Personnel Profiles, Inc. |
| Jamieson, Michael |
Managing Director, I-3 Insource Innovations, Inc. |
| Jancarik, Kent |
Senior Regulatory Associate, BIOGEN - IDEC Pharmaceuticals |
| Jang, Graham, PhD |
Amgen, Inc. |
| Jenkins, John K. |
Director, Office of New Drug, FDA DHHS/FDA/CDER/OND |
| Jensen, Gerard M. |
Director Development & Technical Services, Gilead Sciences |
| Jerian, Susan |
OncoRD, Inc. |
| Jhee, Stanford, PharmD |
Calfornia Clinical Trials, Glendale Adventist Medical Center |
| Johnson, Jerry D. |
Consultant to the Pharmaceutical Industry |
| Johnson, Kathleen, PhD, PharmD |
Associate Professor of Clinical Pharmacy, School of Pharmacy, USC |
| Jones, Andrew |
Regulatory Affairs Librarian, Genzyme |
| Jope, Theodore |
Jope & Associates |
| Jordan-Marsh, MaryAlice, PhD, RN, Faan |
Assistant Professor, Chair Health Concentration, Nurse Social Work, Practitioner, USC School of Social Work |
| Joseph, Joy |
VP, Quality, Technical Operations & Product Development PHARMAVITE Corp |
| Kadow, James |
Asst VP - Corporate Quality Assurance, KADOW ASSOCIATES Ltd. |
| Kalowes, Peggy |
Instructor of Clinical Nursing |
| Kamal, Fred |
Associate Director and Department Head, Chemistry, Amgen, Inc |
| Kaplan, Hilton |
Medical Advisor, Allergan Medical |
| Kaplon, Marsha |
Wyeth, Inc. |
| Kaplowitz Haley J., PhD |
Senior Director, Risk Mgmt & Epidemiology, Allergan, Inc. |
| Kazeminy, Assad |
Founder & CEO, Irvine Pharmaceutical Services |
| Keats, Tony, Esq. |
Lkeats McFarland & Wilson |
| Kennel, Natalie |
Director, Quality, Clinical & Regulatory, PLUS Orthopedics USA, Inc |
| Kessler Larry G., ScD |
Dir: Off of Science & Engineering, CDRH, FDA |
| Keville, Elizabeth |
Laboratory Director, U.S. FDA, Pacific Regional Laboratory/South West |
| Khodavirdi, Ani |
Medical Communications, Oncology, Amgen, Inc. |
| Kiser, Dan |
Senior Director, Quality Assurance, Alphatec Spine |
| Kistner, Kristi |
President, Pacific Otterworks, Inc. |
| Kitzmiller, Cindy |
Executive VP, Seltzer Chemicals |
| Klassen, Dan G. |
Director, RA and QA, Klassen Consulting, LLC |
| Kleiser, Annette, PhD |
Sr. Business Development & Licensing Assoc., USC Stevens Institute for Innovation |
| Ko, Richard |
Research Scientist (Food & Drug), CA Dept. Health Services, Food & Drug Branch |
| Koller, Ron |
Investigator, US FDA |
| Kontnik, Lew |
Brand Protection, Amgen, Inc. |
| Korbin, Gus, RAC CQA |
Medical Device Consultant, Strategic Regulatory Solutions |
| Krieger, Robert, PhD |
Dept. Entomology, UC Riverside |
| Krueger, Carol |
FDA |
| Kubic, Tom |
PSI |
| Kulkarni, Ashutosh, PhD |
Scientist-Pharmacokinetics & Drug Metabolism, Allergan, Inc. |
| Kunas, Gretchen |
Project Manager, KEMA Quality B.V., KEMA Medical |
| Kuo, Benson, PhD |
Manager, Consulting Center, USC Regulatory Science Program |
| LaCorte, Laura |
Executive Director Office of Compliance, Audit and Compliance |
| Lai, Johan |
Chief Operations Officer, Accelerated Approval, Inc. |
| Lam, Nancy |
Amgen, Inc. |
| Landolph, Joseph |
USC Keck School of Medicine, Dept of Molecular Microbiology & Immunology |
| Lassiter, Jim |
Principal, THE LASSITER GROUP |
| Laufer, Jaap L., PharmD |
Managing Director - Europe, Propel Biomedical Consulting |
| Lauro, Stephen, Esq. |
Attorney, President, ColorMaker |
| Lawrence, C. Stephen |
Partner, Hogan & Hartson, LLP |
| Lesko, Larry |
Director, Office of Clinical Pharmacology & Biopharmaceuticals, FDA Center for Drug Evaluation & Research |
| Lewis, Doug, PhD |
Department Chair, Food Science & Human Nutrition, California State Polytechnic University |
| Lieskovan, Ed, Dr. |
President & CEO, Performance Research Labs, Inc |
| Lieu, Cynthia |
Asst Professor of Clinical Pharmacy, USC School of Pharmacy |
| Lisager, Terry, EdD |
Assistant Professor, California State University, Northridge, Department of Family and Consumer Sciences |
| Liu, Marie E. |
Attorney, Associate, K & R Law Group, LLP |
| Lloyd-Smith, Malcolm |
SVP Regulatory Affairs & QA, Cadence Pharmaceuticals, Inc. |
| Loeb, Gerald, MD |
Director, Medical Device Development Facility, Alfred E. Mann Institute |
| Loh, Evangeline |
VP, Regulatory Affairs, EMERGO GROUP |
| Lou, Mimi |
Project Manager & Biostatistician, USC School of Pharmacy |
| Louie, Stan |
Associate Professor of Clinical Pharmacy, USC Department of Pharmacy |
| Lowe, Lester |
Supervising Food and Drug Investigator, California Department of Health Services, Food and Drug Branch |
| Graham-Lyons, Katie |
Senior Consultant, Opus Regulatory |
| Ma, Kimberly P. |
Medtronic, Inc. |
| Macdonald, Douglas, PhD |
Director of Drug Discovery, CHDI Management, Inc. |
| MacKay, Andrew |
Assistant Professor of Pharmacology & Pharmaceutical Sciences, USC School of Pharmacy, Dept of Pharmacology & Pharrmaceutical Sciences |
| Maderazo, Alan, PhD, RAC |
Senior Manager, Regulatory Affairs, Gen-Probe |
| Maffuid, Paul |
Sr. Vice President, Operations, Irvine Pharmaceutical Sciences |
| Maguire, Stacey |
Attorney, Sedgwick, Detert, Moran & Arnold |
| Maletta, Mathew |
Allergan, Inc. |
| Malloy, John |
Malloy and Associates |
| Margolis, Benjamin Robert |
Attorney at Law |
| Marler, William |
Attorney, Marler Clark |
| Mauzey, Duane |
Scientist, Pharmaceutical Analysis, Allergan Inc. |
| McDonald, Janet |
FDA San Francisco |
| McGuffin, Michael |
President, American Herbal Products Association |
| McKay, Brandi |
Attorney, Sedwick, Detert, Moran and Arnold |
| McKinney, Eula |
Manager, Comprehensive Spine Center, UCLA |
| McKonic, Marc |
CEO, Biocell Laboratories, Inc. |
| McNabb, Matt |
Training & Development, Allergan, Inc. |
| Meissel, Richard |
Propel Biomedical Consulting |
| Mendivil, Steven |
Amgen, Inc. |
| Mensh, Stephanie |
VP, Reimbursement Policy Stroke Survivor.com |
| Mercurio, Ken, MS |
President, Label Compliance |
| Messa, Elaine |
Director of Medical Device Quality Systems, Becker & Associates Consulting, Inc. |
| Meyers, Elizabeth |
Associate Manager, Corp. Quality Compliance, Amgen, Inc |
| Miller, Jay |
Associate Director, Clinical Operations - Japan Representative Office, Global Development, Amgen |
| Mire-Sluis, Anthony |
Amgen, Inc |
| Mishra, Lakshmi |
Adjunct Professor, SoCal University of Health Sciences |
| Molzon, Justina |
Sr. Program Management, FDA DHHS |
| Montecalvo, Joe, PhD |
Professor, Food Science and Human Nutrition, California Polytechnic University |
| Moore, Kellie Ann |
Attorney, Sedgwick, Detert, Moran and Arnold |
| Moran, Matthew |
Dir of Global CMC Regulatory Affairs, Allergan, Inc. |
| Morel, Keith, PhD |
Senior Project Manager, KEMA Quality |
| Morton, Michael |
Sr. Director Global Regulatory Affairs, Medtronic, Inc. |
| Mounho, Barbara, PhD |
Amgen, Inc. |
| Nancy, Singer |
Compliance-Alliance, LLC |
| Newburry, Keith Andrew, Esq. |
Edwards Lifesciences, LLC |
| Newman, Joseph B. |
Project Configuration Manager, QA, Diagnostic Products Corporation |
| Ngau, Grace |
USC School Pharmacy |
| Nickell, Robert |
President & CEO, Homelink National Pharmacy |
| Niksch, Barbara |
Vice President, Regulatory, Quality & Clinical Affairs, Visiogen, Inc. |
| Nilsen, Jon, PhD |
Biomedical Writer, Amgen, Inc. |
| Nimmer, Thomas |
Amgen, Inc |
| Niu, Helen, MD |
Two-World Bio-Pharma Consultancy, Beijing, China |
| Novak, Kathleen |
Manager of Medical and Scientific Affairs, Nutrition Division, Nestle |
| O'Brien, Patrick |
Attorney, Johnson & Johnson Law Department |
| O'Meara, Regina J., RAC |
Director, Global Legislative & Government Affairs, Beckman Coulter, Inc., Retired |
| Ortiz Akhondzadeh, Korina |
Regulatory Specialists |
| Pacifici, Eunjoo, PharmD, PhD |
Clinical Research Specialist |
| Pacifici, Robert |
Chief Scientific Officer, CHDI Foundation |
| Pandey, Ajit |
Amgen, Inc. |
| Patel, Leena, PhD |
Allergan, Inc. |
| Patterson, Nancy |
Venture Analyst & Consultant, MedFocus Fund |
| Patterson, Hal |
Director of Quality Assurance, ISTA Pharmaceuticals |
| Perdon, Elisa |
Quality Assurance Manager for Contract Manufacturing, Chattem, Inc. |
| Perkins, Daya |
USC Postdoctoral Fellow, Global Pharmaceutical Sciences, Allergan Inc. |
| Perkowski, Peter, Esq. |
Winston & Strawn, LLP, Los Angeles |
| Perry, Virginia |
Founder and Partner, Perry-D'Amico and Associates |
| Petrime, Matt |
VP, GM of Speciality Division, Applied Medical |
| Pham, Chris |
Attorney, Sayegh & Pham |
| Phillips, Howard |
FOI Services, Advanced Compliance Alliance |
| Phillips, Richard, PhD |
Sr. Vice President, Chief Regulatory Officer, Regulatory Affairs and Quality Assurance, Cougar Biotechnology, Inc. |
| Piazza-Hepp, Toni |
Associate Director for RA, Supervisory Pharmacist, FDA DHHS/FDA/CDER/OSE/RMS |
| Pierce, Gary |
Reg. F&D Director, SW Region HFR-SW1 FDA |
| Pih, Will, PharmD |
President & CEO, BioSys Labs, Inc. |
| Pilcher, Garrett |
Regulatory Affairs Specialist, Medtronic |
| Pitts, Peter |
Porter Novelli |
| Pollmeier, Vincent |
Attorney, Quinn Emanuel et al LLP |
| Potter, Geoffrey |
Patterson Kelnap Webb & Tyler, LLP |
| Posin, Christine |
Consultant in Regulatory and Quality Assurance |
| Prakash, Anu, PhD |
Associate Professor, Department of Physical Sciences, Chapman University |
| Pulicharam, Riya |
Medical Director of Clinical Research, Health Care Partners |
| Purcell, Meredith |
Associate Director, Regulatory Affairs Publishing, Allergan, Inc. |
| Qian, Victoria, PharmD, PhD |
Allergan, Inc. |
| Quattrone, Alfredo, PhD |
DABT, Staff Toxicologist, FDA CA-DHHS |
| Quinn, David, MD |
Associate Professor of Clinical Medicine Oncology, Keck School of Medicine |
| Rastein, Daniel N. |
FDA GLP Compliance Officer, Cedars-Sinai Medical Center |
| Raumbaugh, Trudi |
VP Regulatory Affairs, Baxter Healthcare Corp. |
| Raval, Ruchika |
Ruchika Raval & Associates |
| Reck, Ross |
Ross Reck & Associates |
| Resch, Gerda, RAC |
Manager of Regulatory Affairs, Alfred Mann Foundation |
| Reznik, Phil |
Attorney at Law, BRG&S, LLP |
| Richmond, Frances, PhD |
Director, Clinical & Regulatory Science, AMI Research Professor of Molecular Pharmacology and Toxicology, AMI-USC School of Pharmacy |
| Ripley, Ann-Marie |
Alfred E. Mann Foundation |
| Robb, Melissa A. |
Sr. Program Manager, FDA DHHS/FDA/OC/OCS/OCPP |
| Robertson, Jan |
Manager, Labeling and Advertising Baxter Healthcare Corp |
| Robinson, Robert |
Attorney, Bowman and Brooke LLP |
| Rodriguez, Dana |
RNP, RAC Quality Consultant, Medical Device Industry |
| Rokaw, Enid |
EBR Consulting |
| Roper, Doug |
Director of Laboratory/Quality Assurance, BOTANICALS INTERNATIONAL |
| Rosales, Tita |
Amgen, Inc. |
| Rose, Susan L. |
Executive Director,Office for the Protection for Research Subjects, USC |
| Rosenbloom, Judy |
Founder & President, JR Associates |
| Rosencrans, Heather |
FDA CDRH/ODE |
| Rostami, Reza |
Manager, Clinical Data Services, Duke Clinical Research Institute |
| Rumbaugh, Trudy |
VP, Global Regulatory Affairs, Biologics & Biopharmaceuticals, Baxter Healthcare Corp |
| Rush, Gary |
Senior Food & Drug Investigator, California Department of Health Services |
| Salter, Anne Dupont, M.Eng, PhD |
Instructor, USC Regulatory Science Program, & Queen's Univeristy School of Rehabilitation Therapy |
| Sattler, Fred R., M.D. |
Prof. Medicine & Biokinesiology, USC GCRC Keck School of Medicine |
| Sawyer, Tom |
Retired, FDA/ORA |
| Scanlon, Kevin J., PhD, |
Founder and CEO, International BioScience |
| Schakenraad, Jeff |
Manager, Kema Medical |
| Schneider, Carol |
Irell & Manella, LLP |
| Schultz, Dan, M.D. |
FDA CDRH/ODE |
| Schwartz, Nancy |
Consultant, Searchlight International |
| Scognamillo, Christian |
Attorney, Cooley Godward LLP |
| Serrano, David |
Consumer Safety Officer, FDA Dept. of Health/Human Services |
| Seyedzadeh, Javad |
Sr. VP, Global QA/RA, Gambro Renal Products, Inc. |
| Shaddle, Bill |
Director of Internet Strategy, Metagenics |
| Shaham, Cigal |
Clinical Research Coordinator, Children's Hospital of Los Angeles |
| Shapiro, Daniel K. |
Asst. Director, Office of Compliance/General Counsel, USC Office of Compliance |
| Shapiro, Michael |
Dorothy W. Nelson Professor of Law, USC School of Law |
| Sharma, Avyaya |
Clinical/Quality Engineer, Clinical Research and Clinical Trials Management, Medtronic Vascular |
| Shen, James.C. |
Compliance Officer, US FDA |
| Sherman, Neil |
Watson-Retired |
| Simmons, John |
Supervisory Chemist, OPS, CDER |
| Slomoff, Robert Joel |
Special Consultant Food and Drug Law, Fulbright & Jaworski, LLP |
| Smerkanich, Nancy |
Global Affairs Regulatory, Octagon Research Solutions |
| Smith, Russell, MLS |
Educational Support Librarian, USC Norris Medical Library |
| Son, Michael C., PhD, RAC |
Director, PanGenomics, Inc. |
| Spencer, Helene |
Spencer Instrumentation/ VP, Regulatory Affairs and Quality Assurance, GluMetrics, Inc. |
| Sperber, Stephanie |
O'Melveny & Myers, LLP |
| Spicer, Darcy |
Professor, Head of IRB, Clinical Medicine at USC |
| Spink, Peter, PhD, CPP |
Asso.Dir & Asst Prof, Michigan State University |
| Stagg, Del |
Senior Director, Allergan, Inc. |
| Stahl, Ann |
Federal Trade Commission |
| Standish, Gail, Esq. |
Winston & Strawn, LLP, Los Angeles |
| Stark, Fumi |
Program Director, GNH Unit I USC |
| Stark, Charles |
Reg Med Rsch Spec, Pfizer, Inc. |
| Stearns, Denis, Esq. |
Marler Clark LLP PS |
| Steiner, Randy |
Associate Director, Regulatory Affairs, Amgen, Inc. |
| Storm, Neal |
Regulatory Affairs, Amgen, Inc. |
| Swain, Chris |
Director, USC Games Institute, USC School of Cinamtic Arts |
| Swaroop, Sheila Neha, Esq. |
Knobbe Martens, et al, LLP |
| Swit, Michael A. |
The Weinberg Group, Inc./ Heller, Ehrman, White & McAuliffe LLP |
| Taddonio, Laurie |
President, LMT Consulting, LLC |
| Tadjalli, Virginia |
American Art & Technology |
| Tai, Phyllis, PharmD, M.S., Post-Doctoral Fellow |
Regulatory Strategy & Risk Management, Global Regulatory Affairs, Allergan, Inc. |
| Taylor, Julie |
Tec Solutions |
| Thatcher, Dave |
Amgen, Inc. |
| Thenell, Scott J. |
S. Thenell Company |
| Thompson, Barry |
Partner, Crosby, Heafey, Roach & May (Los Angeles) |
| Thompson, Monica |
Prosecutor, Immigration and Naturalization Services |
| Tonetta, Sharon |
Vice President, Clinical Research and Development, Baxter Healthcare Corp |
| Topham, Debra K.W., MS, RD |
Director, Knowledge Bank |
| Tsai, Yali, PhD, RPh |
VP Product Development, Latitude Pharmaceuticals, Inc. |
| Tucker, Mark, PhD |
Compliance Officer, FDA |
| Ubl, Stephen |
President & CEO, AdvaMed |
| Van Antwerp, Bill |
VP, Chief Scientific Officer, Medtronic Minimed |
| Van Etten, Aaron |
Manager, Medical Writing, Amgen, Inc |
| Vidor, Arlene |
Vice President, Regulatory Affairs, North America, Retired from Baxter |
| Vivirito, Michele |
Principal Medical Writer, Medical Affairs Department, Amgen Inc |
| Volner, William |
Manager, Global Trade Compliance Department , Allergan |
| Walsh, Michael, Esq. |
Attorney, Sedgwick, Detert, Moran and Arnold |
| Wang, Sue-Jane |
Associate Director for Adaptive Design and Pharm, Office of Biostatistics, OTS/CDER/FDA |
| Weber, Jeffrey, M.D. PhD |
USC Norris Cancer Center |
| Weir, Andrea |
Charles River Laboratories, Navigators |
| Weisbuch, Holly |
Assistant Director & Quality Assurance Supervisor, Clinical Investigations Support Office |
| Weismann, Fred |
Associate Dean, Academic & Clinical Affairs, USC School of Pharmacy |
| Were, Lillian, PhD, |
Assistant Professor, Department of Physical Sciences, Chapman University |
| Williams-Hill, Donna M., PhD |
Microbiologist, Food Pathogen Specialist, FDA, Department of Health & Human Services |
| Wilson, Rick |
Allergan, Inc. |
| Winckler, Susan |
President & CEO, Food & Drug Law Institute |
| Witherly, Steve, PhD |
President & CEO, Technical Products Inc.. Nutraceutical consulting firm. |
| Wolfe, Allan, MD |
UV Partners |
| Woodward, Karen |
Attorney, Sedgwick, Detert, Moran & Arnold LLP |
| Wu, Weicheng, PhD |
Regulatory Associate III, Watson Laboratories, Inc. |
| Yedigarova, Larisa, MD, PhD |
Vis Assistant Professor of Research, Obstetrics & Gynecology at USC |
| Yen, Richard |
Cofounder & CEO, Agile Pharmaceuticals, Inc. |
| York, Peter B. |
Analyst, Pharmaceutical Security Institute |
| Yoshida, Hideo |
Director, Reg Affairs, Japan, Amgen, Inc. |
| You, Thomas J. |
Crosby, Heafey, Roach & May |
| Zagari, Martin |
Amgen, Inc. |
| Zineh, Issam, PharmD, MPH |
Associate Director of Genomics, Office of Clin Pharm, Office of Translational Sciences, CDER, U.S. FDA |
| Zink, Donald |
CIFSAN - FDA |
| Zoric, Joe |
Director of Regulatory Affairs, Cougar Biotechnology, Los Angeles |
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