Temple Education Programs

Temple University is a comprehensive public research university in Philadelphia, Pennsylvania, originally founded in 1884 by Dr. Russell Conwell. Temple University is among the nation's largest providers of professional education offering over 300 academic degree programs at seven campuses and sites in Pennsylvania and its international campuses in Rome, Tokyo, and London. It is the 26th largest university in the United States with more than 37,000 undergraduate, graduate, and professional students.

Temple’s Quality Assurance and Regulatory Affairs program is the most comprehensive academic curriculum of its kind, featuring advanced courses in the quality principles and regulatory issues affecting today’s pharmaceutical industry. The program fulfills regulatory requirements for training and also helps individuals develop critical thinking skills in regulatory and quality issues for career advancement.

Benefits of the Program – Quality Assurance and Regulatory Affairs

Program Offered

Clinical Trial Management - This 5-course certificate program is designed for pharmaceutical and healthcare professionals who are interested or already participate in all aspects of clinical trials.  It provides the tools and information needed to design, conduct and audit clinical trials of pharmaceuticals.  The courses emphasize protocol development, volunteer informed consent, study management, and the role and responsibilities of Institutional Review Boards.

Global Pharmacovigilance : Benefit-Risk Assessment – The pharmaceutical industry is challenged with providing oversight of a drug’s safety throughout the product lifecycle.This includes continually reviewing safety profiles and managing and assessing benefit and risk that arise during and after drug development.This certificate provides a foundation in Pharmacovigilance principles to both experienced professionals and those seeking entry into this career field from within and outside the pharmaceutical area.

Eligibility

Course Details

Drug Development : This course studies the drug development process from discovery through FDA marketing approval. It reviews the process of development and the interrelationships linking the various disciplines, introducing students to regulations governing the process, including the interactions with FDA, ICH, and other regulatory agencies.

Note: this course is required for the MS in QA/R and for the Certificate in Clinical Trial Management.

Clinical Drug Safety and Pharmacovigilance : This course provides students with an in-depth understanding of what pre-marketing Clinical Safety and Risk Management (CSRM) means in the context of both American (FDA) and international (ICH-E2C) regulatory requirements. Beginning with an historical overview of IND and international safety requirements, it examines the processes and systems in place to support compliance and the strategic documentation required for applications. It also looks at the role of risk management and epidemiological methods used to identify the signals used to quantify, assess, and communicate adverse drug reactions (ADR). Topics include clinical trial policy, the roles of the investigator, patient, and IRBs, privacy issues, informed consent, DSMB, and other related matters.

Note:  This course counts towards the Certificate in Clinical Trial Management or the Certificate in Global Pharmacovigilance.

Legal and Regulatory Basis of Pharmacovigilance : This course provides students with a basic understanding of the key regulations and laws that influence the development and management of a Pharmacovigilance system,either in a manufacturer or health agency environments. The main emphasis will be on FDA, EU, and Japan and ICH, but discussions of emerging countries’ systems will also be included. In addition to pharmaceuticals, the course provides an overview of the related product vigilance areas, such as medical devices, over-the-counter products, and drug/device combinations. In addition to understanding the regulatory framework, additional instruction will include discussions of partnership agreements, Pharmacovigilance aspects of due diligence, licensing and acquisitions, and product liability issues.

Note:  This course counts towards the Certificate in Global Pharmacovigilance.

Faculty Profile

Experts from industry and FDA teach the classes. All have considerable experience in legal, regulatory, quality, and compliance activities in a variety of companies, fields, and disciplines. A major reason the program has become so successful is the strength of our faculty.

Faculty for the Fall Semester – August to December

Michael J. McGraw, PharmD, MS, serves as the U.S. lead for regulatory strategy for investigational products for Teva Neuroscience in Philadelphia.He is experienced in reviewing and preparing regulatory submissions for investigational drugs as well as negotiating with the U.S. Food and Drug Administration for product approvals.With both regulatory and clinical experience, Dr. McGraw has managed clinical research teams, developed research grants, prepared study documents, submitted documents to IRBs, and created clinical study reports.Previously he worked for Shire and GlaxoSmithKline.A licensed, registered pharmacist, Dr. McGraw has developed position papers to support new indications for approved drugs and has managed post-approval chemistry, manufacturing and controls changes for various products.Adept at navigating the complex area of regulatory strategy associated with clinical trials, he also fully understands the developmental life-cycle of a drug product.He has managed clinical pharmaceutical studies, developed informed consent and case report forms, and managed clinical investigative sites. Dr. McGraw has taught for the QA/RA and PharmD programs of the Temple University School of Pharmacy, where he received his MS in QA/RA and PharmD degrees.

Ms. Chris Wittrock, MS, has worked for the pharmaceutical industry for over 23 years, holding positions at large corporations (Merck and GlaxoSmithKline), a mid-sized company (CSL Behring), and a contract laboratory (Charles River Labs).Her career was launched with research and development experience in osteoporosis and infectious diseases (including Lyme’s disease, Herpes simplex, and HIV).She subsequently gained over a decade’s worth of cGMP and regulatory experience working in clinical microbiology, virology, environmental monitoring, and supporting large-scale vaccine manufacturing.Her portfolio includes change control management, OOS investigations and CAPA management, regulatory documentation management, and employee training.During the past five years, she has focused on drug safety for clinical and marketed products.She graduated with the MS in QA/RA from Temple University, completing the Certificate in Clinical Trial Management.She then earned teaching certification.She has been an instructor in the QA/RA graduate program since fall 2010, offering courses in Drug Development, Bioethics, and Clinical Drug Safety and Pharmacovigilance.

Don Wallace, MD, has over twenty years of experience in medical monitoring and drug safety assessment in the pharmaceutical industry.After receiving his MD from Temple University School of Medicine, he subsequently pursued a career in Clinical Research, working for various companies, including McNeil Consumer Products, Wyeth-Ayerst Research, Solvay Pharmaceuticals, and several Clinical Pharmacology units at University Medical Schools (including Temple and Allegheny).He eventually became Director of Clinical Pharmacology and Discovery Medicine at GlaxoSmithKline, where he coordinated strategic clinical development plans and implemented multimillion dollar phase IV Post Marketing Surveillance of clinical research projects.