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Fundamentals of US Regulatory Affairs, 10th Edition
by Various Contributors, Pamela Jones, Syed Rizwanuddin Ahmad, Cassie Alexander, Berry Berger, Mitchell Berger, Peggy Berry, Charles Breen, David Brindley, Elizabeth Campbell, Kell Canon, Carol Cooper, Pallavi Sharma Das, Sunny Kamlesh Dave, Seameen Dehdashti, Cindy Dibiasi, Jim Dibiasi, Joy Frestedt, Abhishek Gurnani, Robert Guzman, Michael Hinckle, Karen Jaffe, Jocelyn Jennings, Angela Johnnson, Kurt Karst, Allison Komiyama, Mona Koshkouei, Carrie Kuehn, Evangeline Loh, Demetra Macheras, Robert Martin, Nancy Mathewson, Kirsten Messmer, Bernard Naughton, Tina O'brien, Valerie Ramsey, Sarah Robinson, Joanne Rupprecht, Alexandra Beumer Sassi, Kathrin Scalper, Charity-Anne Schuller, Kandarp Shah, William Sietsema, Andrew Slade, James Smith, Edward Steele, Ashhish Talati, Nancy Teague, Snehal Trivedi, Gresham Weatherly, Martha Wells, Jennifer Wilhelm, Holly Winchell, Linda Yang
Hardcover, Published 2017 by Regulatory Affairs Professional Society (Raps)
ISBN-13: 978-0-9977697-7-7, ISBN: 0-9977697-7-7






Fundamentals of International Regulatory Affairs, Third Edition
by Pamela Jones, Zeeshaan Arshad, Nicole Beard, Gert Bos, David Brindley, Orin Chisholm, Rosie Dawes, Elizabeth Goldstein, Xiaoli Gou, Nathalie Innocernt, Colin Jacob, Jocelyn Jennings, Mona Koshkouei, Evangeline Loh, Bernard Naughton, Megumi Nozawa, Terrance Ocheltree, Joanne Rupprecht, Manfred Ruthsatz, Nic Scalfarotto, Kathrin Schalper, William Sietsema, David Silberstein, James Smith, Raajdeep Venkatesan, James Ware, Lin Wu
Hardcover, 440 Pages, Published 2017
ISBN-13: 978-0-9969491-9-4, ISBN: 0-9969491-9-4






Fundamentals of International Pharmaceutical & Biologics Regulations(1st Edition)
by Pamela Jones, Zeeshaan Arshad, Nicole Beard, David Brindley, Orin Chisholm, Rosie Dawes, Elizabeth Goldstein, Nathalie Innocent, Colin Jacob, Jocelyn Jennings, Mona Koshkouei, Bernard Naughton, Megumi Nozawa, Terrance Ocheltree, Kathrin Schalper, William Sietsema, David Silberstein, James Smith, James Ware, Lin Wu
Hardcover, 252 Pages, Published 2017 by Regulatory Affairs Professionals Society (Raps)
ISBN-13: 978-0-9977697-3-9, ISBN: 0-9977697-3-4






Fundamentals of International Medical Device Regulations
by Zeeshaan Arshad, Gert Bos, David Brindley, Elizabeth Goldstein, Xiaoli Gou, Jocelyn Jennings, Evangeline Loh, James Smith
Published 2017
ISBN-13: 978-0-9977697-1-5, ISBN: 0-9977697-1-8






Global Medical Device Regulatory Strategy
by Various Contributors, Prithal Bom, Gert Bos, David Brindley, Joanna Brougher, Andrew Carr, Stanely Chalvire, Tony Chan, Xianjun Chen, Mark Chipperfeld, Raymond Chua, Stewart Crumpler, Benjamin Davies, Sean Detweiler, Scott Dickerhoff, Sue Dopson, David Fazzolare, Melissa Gaynor, Elisabeth George, Jeffrey Gibbs, Ann Goodall, Dorota Grabowska, Susan Hibbeln, Tom Hutchinson, Chie Iwaishi, Jocelyn Jennings, Amit Kukreja, Michael C. Morton, Allyson Mullen, Nobuko Nakajima, Dawn Norman, Penny Northcutt, Matthew O'donnell, Gretchen Parker, Sethuraman Rama, Taranjit Samra, Philip Sax, Maria Shepherd, Michael Siano, James Smith, Manuel Urena, Brian Young, Melissa Walker, Lisa Warren, Karolina Wartolowska, Pamela Weagraff, Michelle Wu
Hardcover, 320 Pages, Published 2016 by Regulatory Affairs Professionals Society (Raps)
ISBN-13: 978-0-9969491-3-2, ISBN: 0-9969491-3-5






Fundamentals of US Regulatory Affairs, Ninth Edition(9th Edition)
by Various Contributors, Pamela Jones, Pamela A. Jones, Mujadala Abdul-Majid, Maham Ansari, Maje Babatola, Rajaram Balasubramanian, Barry Berger, Mitchell Berger, Jr. Christopher Braudis, Charles Breen, David Brindley, Meredith Brown-Tuttle, Elizabeth Campbell, Andy Carr, Michael D'amico, Abhishek Gurnani, Brian Harvey, Nathalie Innocent, Treena Jackson, Jocelyn Jennings, Naseem Kabir, Allison Komiyama, Carrie Kuehn, Irina Kulinets, Anne Maczulak, Robert Martin, Meredith May, Vic Mencarelli, Shekhar Natarajan, Maruthi Prasad Palthur, Nisha Pandya, Mitchell Parrish, Nancy Perrella, William Putnam, Brock Reeve, Helen Ribbans, H. Carol Saul, Anthony Schiavone, Sharad Shukla, William Sietsema, Samrat Sisodia, James Smith, Edward Steele, Clark Sullivan, Ashish Talati, Auresa Thomas, Adria Tyndall, Richard Vincins, Martha Wells, Jennifer Wilhelm, Andrew Zeltwanger
Hardcover, 604 Pages, Published 2015 by Regulatory Affairs Professionals Society (Raps)
ISBN-13: 978-0-9673115-8-6, ISBN: 0-9673115-8-6






Fundamentals of US Pharmaceutical & Biologics Regulations
by Pamela Jones, Syed Rizwanuddin Ahmad, Cassie Alexander, Sunny Kamlesh Dave, Joy Frestedt, Michael Hinckle, Jocelyn Jennings, Kurt Karst, Kirsten Messmer, Sarah Robinson, Alexandra Beumer Sassi, Charity-Anne Schuller, Kandarp Shah, William Sietsema, Andrew Slade, James Smith, Snehal Trivedi, Martha Wells, Jennifer Wilhelm, Linda Yang
Hardcover, Published 2017 by Regulatory Affairs Professional Society (Raps)
ISBN-13: 978-1-947493-01-8, ISBN: 1-947493-01-9






Regulatory Writing
An Overview
by Danny Benau, Joanne Rupprecht, E. Mitchell Seymour, Robin Martin, Jenny Boyar, Jenny Grodberg, Mariam Aslam, Steve Carr, Helle-Mai Gawrylewski, Sharanya Balasubramanian, Brooke Diorio, John Ellison, Anna Mendlin, Bertil Wagner, Jocelyn Jennings, Nathalie Innocent, Kayla Ambroziak, Monica Ramchandani, Jiyang Shen, Beth Silverstein, Eileen Girten, Michelle Carey, Pamela Jones
234 Pages, Published 2017
ISBN-13: 978-0-9977697-5-3, ISBN: 0-9977697-5-0






Fundamentals of US Regulatory Affairs, Eighth Edition(8th Edition)
by Alix E. Alderman, Clawson Bowman, Alay Bhayani, Patricia Anderson, Evelyn D. Cadman, Pamela Anne Jones, Rafael Cassata, Melissa Cavuto, Ojas Chandorkar, Min Chen, Joseph C. Fratantoni, Klaus Gottlieb, Michael R. Hamrell, Donna Helms, Hutch Humphreys, Treena Jackson, Karen Jaffe, Jocelyn Jennings, Allison Kennedy, William H. Kitchens, Tatiana Leshchinsky, Alan Minsk, Brian Miyazaki, Linda Pollitz, M. Prasad Palthur, Giuseppe Randazzo, Matthew Rycyk, Srikonda Sastry, Anthony P. Schiavone, Jessica W. Smith, Michelle Sotak, Usha Srinivasan, Michael A. Swit, Mya Thomae, Anne Tomalin, Laurence M. Wallman, Maria Walsh, Diane R. Whitworth, Sherry Yanez Gregor, Linda Yang, Andrew P. Zeltwanger, Jeffrey Zinza
Paperback, 540 Pages, Published 2013 by Regulatory Affairs Professionals Society
ISBN-13: 978-0-9829320-6-3, ISBN: 0-9829320-6-5

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