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Volunteer faculty for 2001-2002 academic year honored

The Faculty Recognition Awards Ceremony for the 2001-2002 academic year was held on May 14 to recognize and honor FDA employees who planned, developed and taught courses to their colleagues. They provided subject matter knowledge, conducted research and developed lesson plans on their own time and without compensation in addition to performing their current jobs. Their efforts support CDER's mission by providing training and orientation to CDER staff.

To say "thank you" to CDER faculty for their hard work, the Division of Training and Development in the Office of Training and Communications holds an annual recognition ceremony. The education and training mission of the Center cannot be fulfilled without their support.

Opening remarks were provided by Nancy D. Smith, Ph.D., OTCOM's director, and .Janice Newcomb, DTD's director. The awards were presented by DTD's project managers.

The courses, retreats, workshops and individual faculty recognized were:

An Introduction to the Center for Drug Evaluation and Research-CDER 101: Kathleen Bongiovanni, Nicholas Buhay, Igor Cerny, Pharm.D., Jean-Ah Choi, Pharm.D., John Dietrick, Antoine El-Hage, Ph.D., John Friel, J.D., Roger A. Goetsch, Pharm.D., David J. Graham, M.D., MPH, Roger C. Gregorio, Debbie Henderson, David Hilfiker, Carol Holquist, R.Ph., Carolyn L. Hommel, David A. Konigstein, David A. Lepay, M.D., Ph.D., Norman Marks, M.D., Andrea Masciale, Justina A. Molzon, Pharm., J.D., Toni Piazza-Hepp, Pharm.D., Barry W. Poole, Lisa Rarick, M.D., Fredric J. Richman, Terri F. Rumble, Joseph Salewski, Ellen Shapiro, Ted Sherwood, John E. Simmons, Ph.D., Nancy D. Smith,
Ph.D., Kimberly Littleton Topper, Robert L. West, James Wilson, Sally Winthrop, Janet Woodcock, M.D.

Basic Presentation Skills: R. Daniel Benz, Peter Cooney, Robin Huff, Ph.D., Lana L. Pauls, MPH, Thomas Permutt, Ph.D., Victor Vail, Steve Wilson,
Dr.P.H.

Basic Statistical Methods: Ruthie Davi, Karen M. Higgins, Sc.D., Kate Meaker, Dionne L. Price, Ph.D., George Rochester, Ph.D.

Basic Topics in Applied Statistics: Survival Data Analysis: Kate Meaker.

Best Pharmaceuticals for Children Act Training: Grace N. Carmouze, Terrie Crescenzi, Christine Moser, Dianne Murphy, M.D., Rosemary Roberts,
M.D.

Carcinogenicity Course: Lawrence F. Sancilio, Ph.D.

CDER Administrative Management Training for Senior Managers: Tanya Abbott, J. Richard Allen, Ph.D., Susan S. Allen, M.D., MPH, Paula Bourkland, Deborah Breedan, Debbie Henderson, MSN, Bobbi Jones, Michelle L. Mathias, Linda McGee, Jamie Metz, William Oswald, Tammy Russell, Rixie Scott, Rita Thompson, Sandi Van Buskirk, Rich Vengazo, Jack Walsh.

Clinical Reviewers Retreat: Thomas Abrams, Marcello Barreiro, M.D., Eric Bastings, M.D., Bill Boyd, M.D., Peter Bross, M.D., Kim Colangelo, Edward M. Cox, M.D., MPH, Gerald Dal Pan, M.D., Mandy Eisemann, Cindy Fitzpatrick, John Friel, J.D., David Gan, M.D., Jennifer Harris, M.D., Rob Harris, M.D., Ph.D., Sharon H. Hertz,
M.D., Mark S. Hirsch, M.D., Steven Hirschfeld, M.D., Ph.D., Raymond Joseph, M.D., Len Kapcala, M.D., John V. Kelsey, DDS, Scheldon Kress, M.D., Deborah B. Leiderman, M.D., Markham C. Luke, M.D., Ph.D., Armando Oliva, M.D., William Oswald, Philip H. Sheridan, M.D., Nancy D. Smith, Ph.D., Susan J. Walker, M.D.

Committee for Advanced Scientific Education: Hamid R. Amouzadeh, Ph.D., Aisar Atrakchi, Ph.D., Shukal Bala,
Ph.D., Narayana Battula, Ph.D., Karen Davis-Bruno, Ph.D., Mamta Gautam-Basak, Ph.D., Karen M. Higgins, Sc.D., Markham C. Luke, M.D., Ph.D., Joette Meyer, Ph.D., Thomas F. Oliver, Ph.D., Mary Purucker, M.D., Ph.D., John Quinn, M.S., Curt Rosebraugh, M.D., MPH, Sandip K. Roy, Ph.D., Arzu Selen, Ph.D., Philip H. Sheridan, M.D., Milton J. Sloan, Ph.D., Rajeshwari Sridhara, Ph.D., Chair, Kathleen Uhl, M.D., Sue Jane Wang, Ph.D., Josie Yang, DDS, Ph.D., Mona Zarifa, Ph.D.

Derm and Dental Journal Club: Marhkam C. Luke, M.D., Ph.D., Hon-Sum Ko, M.D.

Design, Conduct and Review of Clinical Trials: Aloka G. Chakravarty, Ph.D., Victor Raczkowski, M.D., Kathy M. Robie-Suh, M.D., Ph.D., Philip H. Sheridan, M.D., Robert J. Temple,
M.D., Grant Williams, M.D., Steve Wilson, Dr.P.H.

Division of Metabolic and Endocrine Drug Products Journal Club: Bruce Stadel, M.D., MPH, Joanna K. Zawadzki, M.D.

FDA/DIA Overview of the Pharmaceutical Industry: An FDA-Industry Dialog on the Drug Development Process: Susan S. Allen, M.D., MPH, Lisa Rarick, M.D., Nancy D. Smith, Ph.D.

Human Pregnancy Outcome Data: J. Edward Fisher, Jr., Ph.D., Dianne L. Kennedy, MPH, Sandra Kweder, M.D., David Morse, Ph.D.

IMS: Data View: Katrina Garry, Martha O'Connor.

IMS: In Search of Solutions: Katrina Garry, Martha O'Connor.

IND Regulations and Policies: Tawni M. Schwemer, Bronwyn Collier, Melodi J. McNeil, Robbin Nighswander, Cathie Schumaker, Melissa Truffa.

Inhalation Drug Product: Wallace P. Adams, Ph.D., John Alexander, M.D., Michael G. Bazaral, Ph.D., M.D., Elizabeth Koller, M.D., Lydia McClain,
M.D., Robert J. Meyer, M.D., Luqi Pei, Ph.D., L. Ross Pierce, M.D., Mary Purucker, M.D., Ph.D., Brian Rogers,
Ph.D., Lawrence F. Sancilio, Ph.D., Gur Jai Pal Singh, Ph.D., Eugene J. Sullivan, M.D.

International Foreign Regulator Series: Andrea Feight, DMD, MPH, Justina A. Molzon, Pharm.D.

Introduction to IMS Health Information: Katrina Garry, Martha O'Connor.

NDA Regulations and Policies: Bronwyn Collier, Julieann DuBeau, MSN, Michael M. Folkendt, Ellen C. Frank, Melodi J. McNeil, Robbin Nighswander, David L. Roeder, Terri F. Rumble, Cathie Schumaker.

New Drug Development in the United States: Brenda Kiliany, Pharm.D., Mary Kremzner, Pharm.D, Larry Lim, Pharm.D., Barry W. Poole.

New Employee Orientation: Laura Alvey, Laura Bradbard, Magdalene D. Carolan, Roy Castle, Heather Chafin, Nichelle Cherry, Lois G. Chester, MLS, Jean-Ah Choi, Pharm.D., Eric P. Duffy, Ph.D., Elaine Frost, Mike Jones, Deborah L. Kallgren, Karen Kapust, Lana G. Kostecka, Kathy Kruse, Andrea Masciale, Judit Milstein, Wayne H. Mitchell, Brian Pendleton, Crystal L. Rice, Terri F. Rumble, Ellen Shapiro, Ted Sherwood, John E. Simmons,
Ph.D., Brad Stone, Michael Theodorakis, Sally Winthrop, Bob Young.

New Reviewers Workshop: Fred K. Alavi, Ph.D., Magdalene D. Carolan, Igor Cerny, Pharm.D., Kim Colangelo, James Tristan Cross, Susan M. Cruzan, Ruthie Davi, Gregg Davis, Antoine El-Hage, Ph.D., Amy L. Ellis, Ph.D., Steven K. Galson, M.D., MPH, Joseph Hanig, Ph.D., Mark S. Hirsch, M.D., Dena Hixon, M.D., Elaine J. Hu, Claudia B. Karwoski, Pharm.D., Margie Kober, Kathleen Kolar, Kofi A. Kumi, Ph.D., Randy Levin, M.D., Sheldon Markofsky, Ph.D., Frederic J. Marsik, Ph.D., Kate Meaker, Judit Milstein, Jim Morrison, Armando Oliva, M.D., Lana L. Pauls, MPH, Gerald M. Rachanow, P.D., J.D., Lisa Rarick, M.D., John R. Senior, M.D., Nancy D. Smith, Ph.D., Lisa L. Stockbridge, Ph.D., Anne Trontell, M.D., MPH, Michael J. Verdi, Janet Woodcock, M.D.

Pharmacogenetics: Susan Jerian, M.D., Lawrence Lesko, Ph.D., Frank D. Sistare, Ph.D., Robert J. Temple, M.D.

Presenting at Advisory Committee Meetings: Heather Chafin, Lana G. Kostecka, Gemma Kuijpers, Ph.D., Marianne Mann, M.D., Andrea Masciale, Joy Mele, Michael Ortwerth, Ph.D., Thomas Permutt, Ph.D., Kathleen Reedy, Kimberly Littleton Topper.

Regulatory Science: E. Dennis Bashaw, Pharm.D., Browyn Collier, Antoine El-Hage, Ph.D., Charles P. Hoiberg, Ph.D., Thomas Laughren, M.D., Melissa Moncavage, Robert E. Osterberg, Ph.D., Grant Williams, M.D., Steve Wilson, Dr.P.H.

Searching PubMed: Nichelle Cherry, Lois G. Chester, Nancy L. Muir, Colleen Pritchard.

The Workshop for Non-Inferiority Trials: Charles Anello, Sc.D., Erica Brittain, Ph.D., George YH Chi, Ph.D., Lisa A. Kammerman, Ph.D., Marianne Mann, M.D., S. Edward Nevius, Ph.D., Robert T. O'Neill, Ph.D., Robert J. Temple, M.D., Susan Thompson, M.D., Marc K. Walton, M.D., Ph.D.

Topics in Applied Statistics: Issues in Design and Analysis of Diagnostic Clinical Trials: Michael Welch, Ph.D., Victor Raczkowski, M.D.

Topics in Clinical Trials: Susan S. Ellenberg, Ph.D., Judith A. Racoosin, M.D., MPH, Robert J. Temple, M.D.

Videoconferencing Skills Cours: Ayse N. Hisim, Pam Winbourne.

Videoconferencing/Teletraining and Satellite Broadcast Focal Points: Arthur Bryant, James Black, John Black, Mandy Eisemann, John Franolic, Patricia E. Long-Bradley, Merla Matheny, Jody Moore, Paul Neff, Laura Riddle, Doris Ann Robinette, Christine Shipe, John Schupp, Adolph Vezza, Ruth Warzala, Donnie Wisner.

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