Centennial Scholarship Award
Description of Scholarship Program
To help commemorate the FDA Centennial, the FDA Alumni Association has established a scholarship fund for students enrolled in the Temple University School of Pharmacy’s Quality Assurance/Regulatory Affairs graduate program.
The FDAAA Centennial Scholarship Award was announced at the FDAAA annual meeting April 5, 2006 in Washington. Pharmacy School Dean Peter H. Doukas, Ph.D., and Wendy Lebing, assistant dean, quality assurance/regulatory affairs graduate program, received the award from FDAAA Chairman John C. Villforth and Robert W. Sauer, chairman of the FDAAA Scholarship Committee.
FDAAA Establishes Scholarship Fund for Temple Pharmacy School’s QA/RA Program
The endowment, currently more than $ 52,000, creates the first scholarship in the school’s QA/RA program. FDAAA established the endowment to commemorate the 100th anniversary of the Pure Food and Drugs Act and to encourage academic training in regulatory and quality issues, according to Villforth. FDAAA selected Temple after reviewing graduate programs of schools nationwide. “It was a logical choice, after seeing Temple’s outstanding program and long-standing relationship with the Food and Drug Administration,” said Sauer. Since 2000, the school has worked closely with FDA in sponsoring an annual conference, “FDA and Industry in Dialogue.” FDA staff also lecture for and teach in the QA/RA program, which is based in Fort Washington, Pa. Each semester over 700 students enroll in QA/RA courses, which are taught by industry experts representing virtually every major pharmaceutical corporation in the U.S., according to the school’s Website.
Donations to the fund have come from pharmaceutical trade associations, including the PhRMA Foundation, drug firms, and FDAAA members. Donations are still being accepted.
Upon receiving the award, Doukas said, "Temple School of Pharmacy is most appreciative and honored to receive this generous FDAAA Centennial Scholarship on the occasion of the Agency's Centennial. We thank the FDAAA on behalf of the students who will benefit and for the recognition of the QA/RA program that it symbolizes."
Temple University School of Pharmacy is a pioneer in providing advanced academic coursework in quality assurance and regulatory affairs, which refer to the quality practices and regulations governing the pharmaceutical, medical device, biotechnology, healthcare and consumer products, and related industries. The school was the first to create a master’s program in QA in 1968. In the 1990s, the school created the first academic certificate programs in drug development, clinical trial management, and medical device regulation.
Scholarship Award Recipients
The 5 recipients of full or partial FDAAA scholarships in 2013:
Donald Ertel MT(ASCP) is a Regulatory Officer for the Division of Manufacturing and Product Quality at the FDA's Center for Biologics Research and Evaluation and also a commissioned officer in the United States Public Health Service. LCDR Ertel holds a B.S. Degree in Medical Technology from the University of Maryland. For almost three years, Donald's primary responsibility at the FDA has been performing scientific regulatory review (CMC) of BLAs, PMAs and supplements. He is a qualified lead inspector for CBER performing pre-license and pre-approval inspections for BLAs and supplements. LCDR Ertel has over 20 years of experience working in Quality Assurance and Compliance in and with regulated industries of Blood Banking & Cell Therapy (prior employment at Johns Hopkins Hospital), Biotechnology, and Pharmaceuticals (prior employment at Shire). When he is not performing duties to promote and protect the health and safety of our nation, Donald is pursuing nonstop activities with his wife and three daughters or his musical endeavors as a tenor in the USPHS Choral Ensemble and bass player. Having received the certificate in Drug Development, Donald is truly grateful and honored to receive this award, and is thrilled to continue his pursuit of the QA/RA Master's degree at Temple.
Ding Ding received a bachelor's degree in Chemistry from Peking University in China before coming to the United States to pursue a master's degree in Chemistry from the Catholic University of America in Washington, D.C. Her career in the pharmaceutical industry started as a scientist at DuPont Pharmaceuticals. Upon joining Pfizer, she initially worked as a Bioanalytical Analyst, developing and validating bioanalytical assays for GLP studies and clinical trials for regulatory submissions. She then became a Regulatory Document Specialist, working within the Submission, Toxicokinetic, and Reporting Group focusing on Pharmacokinetics, Dynamic and Metabolism. While working at Pfizer, she received the company's Individual Performance Award eight times, a distinction that recognizes exceptional performance and excellent leadership. Currently enrolled in the QA/RA graduate program, she has already applied her coursework knowledge to the writing of regulatory reports and documents for submission and to the increased awareness of how global clinical trials are conducted. Ding finds the flexibility of the QA/RA program supports her ability to juggle her time between a professional career, family and two small children.
With an MS degree in both nursing and education, Margery is licensed as a registered professional nurse and as a nurse practitioner in family health. She is also certified as a public school teacher, having majored in Special and Elementary Education. In her professional nursing career, she has achieved Level III critical care nurse status (the highest level of achievement as a staff nurse), which has proved to be invaluable experience for her subsequent work as a member of global product surveillance teams at pharmaceutical companies. In particular, she learned first-hand about the critical importance of diligent investigation of side effects when she served as a contract worker for Bausch & Lomb and witnessed the recall of ReNu ML. Currently, she assesses adverse events for both pre- and post-market products as a Drug Associate for Lundbeck, Inc., which specializes in CNS disorders. Residing in Rochester, NY, with her husband and four children, Margery is pursuing Temple's QA/RA program to enhance her knowledge of pharmacovigilance.
From India, Mr. Vishalkumar Patel completed his Bachelor of Pharmacy degree from Rajiv Gandhi University BEA school of Pharmacy in 2006. He then earned his Bachelor of Pharmacy Honors degree from Nirma University School of Pharmacy in 2010. Currently he is working as a Pharmacy Graduate Intern, while pursuing his Pharmacy practice license in United States. His professional interests include academia, research, drug regulation and administration which made him pursue the Master of Science in QA/RA at Temple University in 2011. He plans to pursue a career in the pharmaceutical industry. In addition, he has a greater goal of improving access to medicines in developing countries, while also becoming involved in providing health care to underserved areas both in the U.S. and overseas. He wishes to thank the FDAAA for their scholarship and also wishes to thank his family, friends, and mentors for their continued support and encouragement.
A Senior Specialist at Accenture (formerly Octagon Research Solutions) in the Regulatory Operations department, Jillian holds a degree in Chemistry with a minor in Mathematics from Lafayette College. For the past five years, Jillian's career work has focused on building eCTD submissions including NDAs, INDs, MAAs, and CTAs. She serves as Project Manager on multiple client projects including eCTD submissions, document formatting, SPL, and submission readiness. Having seen first-hand how adverse events affect patients, she believes patient safety should always be the driving goal during drug development. She says her Temple University classes have given her an overview of the drug development process and enabled her to perceive issues beyond her specific niche. As her company expands globally, she is already putting into practice the principles she has learned in Temple classes. She will finish her Masters in QA/RA in December 2013.
How to Apply for Scholarship
The FDAAA scholarship is open to current and new students in Temple’s QA/RA graduate program who are not eligible for tuition reimbursement at their organization. The scholarship will be awarded on the basis of both financial need and academic merit. The first award will be given for the fall 2006 semester and will consist of the tuition costs for one QA/RA course (exclusive of computer and technology and other applicable fees). A selection committee consisting of the dean, assistant dean, director of graduate studies, and at least two QA/RA faculty members will make the final selection. The recipient will be announced in early September.
For further information, contact:
Temple University School of Pharmacy
Quality Assurance/Regulatory Affairs Graduate Program
Attention: Wendy Lebing, MALD, MS, Assistant Dean
How to Donate to Scholarship Fund
There are many students in the Temple University School of Pharmacy’s Quality Assurance/Regulatory Affairs graduate program who have no source of funding for their education and would be grateful to receive financial support. You can make a difference in a student’s life by sending donations to the FDAAA Centennial Scholarship Fund. All donations go directly to the FDAAA Centennial Scholarship and are tax deductible, as permitted by federal law. (FDAAA is a 501(c)3 non-profit organization.) For more information please contact:
Christopher Van Vessem
Director of Development
School of Pharmacy
3307 North Broad Street
Philadelphia, PA 19140
Contributions can be made by check or credit card:
Credit Card Donation: