The  Regulatory  Affairs  

Track  at  Yale  University  

 

 

 

 

 

 

 

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The  Regulatory  Affairs  Track  at  Yale  University  

General  Information  

 

 

 

 

 

REGULATORY AFFAIRS TRACK Robert Makuch, Ph.D. Director, Regulatory Affairs Track Professor of Biostatistics INTRODUCTION Every drug, medical device, diagnostic test, and food sold in the US meets a rigorous set of standards that is intended to ensure products meet a set of safety and performance objectives. When products are transported across state lines, the US Food and Drug Administration (FDA) has been given the authority through federal law (Code of Federal Regulations) to oversee Sponsors producing these products. Both governmental agencies and industry sponsors must adhere to these codes. Because science and technology are moving at an ever-increasing pace, the food, drug, and medical and diagnostic device industries must ensure that quality and regulatory requirements are met. Scientists must possess the knowledge and expertise to create and implement high-quality systems as well as understand the environment encompassing regulatory compliance. Other essential skills include project management and leadership, scientific tools that allow for proper risk assessment and risk management strategies, and the ability to identify and use clear communication practices to convey essential information to technical and non-technical audiences.

The Regulatory Affairs Track (referred to as Track hereafter) at the Yale School of Public Health (YSPH) represents a graduate-level standard in training Masters students. All lectures will adhere to widely accepted regulatory principles, from governmental and industry sponsor viewpoints. This Track will prepare students for future roles in the area of quality control and regulatory affairs. The Track is necessarily multi-disciplinary, to reflect the full array of issues that one may face in regulatory affairs science including complex issues involving food and drug law, ethics, clinical trials, epidemiology, risk analysis, and leadership and change management. Most of these areas of expertise reside within YSPH, and are represented currently within the various YSPH divisions and their faculty. Outside speakers will be invited to share their regulatory experiences with students and faculty. These outside guest speakers are leaders in their areas of practice, including food and drug law, regulatory affairs at the global level, and current topics of special interest to the US FDA and international regulatory agencies. This Track will operate within the existing YSPH academic structure, and Track students will receive a certificate of completion upon graduation from the YSPH.  

 

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 The Track has as its academic core the YSPH core curriculum, and students will complete all the requirements of their home academic division. The core courses for the Track within YSPH will provide training in the scientific basics applicable to regulatory affairs. In addition, the Track will include a new course that addresses areas having a direct regulatory affairs focus. Finally, there are a group of elective YSPH courses that exist currently, to round out the Program.

STUDENT BENEFITS AND OBLIGATIONS

Each student who completes the required coursework will, upon YSPH graduation, receive a Regulatory Affairs Track Certificate of Completion.

Second, Professor Makuch will provide advice to Track members, including significant help with placements for summer internships between academic years 1 and 2, and job searches during spring of year 2 prior to graduation. Guidance will be in addition to, and not replace, existing and established student-faculty advisor relationships.

Third, funding from the Track will provide students with registration/travel/other support to a regional meeting (ie, Northeast/Middle Atlantic states) that is appropriate for regulatory affairs training. This year, the annual Drug Information Association meeting composed of 25,000 members is being held in Washington DC. It is an excellent example of a representative meeting for Track students. No funds outside of the Track, currently funded by Bayer Pharmaceuticals, will be requested.

Fourth, Track students will be provided, by having a bimonthly luncheon, a forum to discuss regulatory topics of current interest and an opportunity to meet with speakers involved in this professional area.

A student becomes a formal member of the Track through application, preferably (but not necessarily) occurring upon successful completion of first-semester coursework in the fall of their first year. Entry into the new course entitled “Introduction to Regulatory Affairs” can take place either in Year 1 or Year 2. The application process includes a resume and a (100-150 + word) statement of purpose explaining how the Track may help them meet academic and professional goals. The application will be reviewed by Professor Makuch. The student will be notified in writing by this committee of acceptance into the Track, and the Track Director will inform the Registrar when a student is admitted to the Track.

 

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COURSES FOR THE REGULATORY AFFAIRS TRACK

Required Courses

Course Number Course Title

BIS 575b Introduction to Regulatory Affairs

BIS 540a Fundamentals of Clinical Trials Elective Courses Two of the following electives: Course Number Course Title

BIS 561b Advanced Topics and Case Studies in Multicenter Trials CDE 650a Introduction to Evidence-Based Health Care EHS 511a Applied Risk Assessment HPM 570a Cost-Effectiveness Analysis and Decision-Making HPM 588a Public Health Law

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LEARNING OBJECTIVES FOR THE REGULATORY AFFAIRS TRACK

Upon completion of the Track, students will be able to:

Utilize the best scientific and ethical standards that prepare you to ensure food, pharmaceutical, and medical and diagnostic devices meet quality and regulatory standards.

Develop/use leadership and management skills for conducting/overseeing research and clinical studies that are required by regulatory agencies.

Develop processes that will ensure clear and consistent decisions to the public and to regulatory agencies.

Assess/develop risk management strategies that can be used to get new products to the market swiftly, while assuring the consumer and regulatory bodies that efficacy and safety have been adequately preserved.

FACULTY GOVERNANCE

Dr. Robert Makuch will serve as director of the Regulatory Affairs Track. In addition, there are several faculty members who will provide guidance and support in the ongoing development of the Program. They are Professors Marguerite Callaway, Robert Makuch, Peter Peduzzi, and Tongzhang Zheng. Dr. Maria Ciarleglio, Associate Research Scientist in Public Health (Biostatistics) at Yale and former West Haven Veterans’ Administration Cooperative Studies Program, also will participate in the Track. Each member brings their special area of expertise to the Program, including but not limited to expertise in conducting large-scale epidemiologic studies, knowledge of assessing risk, relationships with the Chinese State Food and Drug Administration (SFDA), which may provide future students an outlet for their training in the Track, expertise in leadership training and change management, and practical case studies in these areas.

 

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ADDITIONAL BACKGROUND/SUMMARY OF NEW COURSE REQUEST

I summarize below the course description for a proposed new YSPH course entitled “Introduction to Regulatory Affairs”. The full course request is available in a separate document. I wish to point out that I will be in attendance at all lectures, whether or not I will deliver the specific lecture, to provide continuity of purpose throughout the course. These lecture topics have been used in past presentations/training sessions held for senior leadership of the Chinese SFDA and in other training programs. These 5-8 day training sessions have been held at YSPH in the past, with more than 140 SFDA delegates in attendance. Thus, this introductory course is based on past experience and success. Moreover, this series of topics represents a coherent set of lectures/information that has been successfully presented to and well received by governmental regulatory authorities. Margaret Hamburg, the current Commissioner of the US FDA, and the YSPH graduation speaker in 2010, has identified the need for academic institutions to continue to evolve in their training of individuals in the area of regulatory affairs. In a recent speech to the FDA Science Board (8/18/2009), Dr. Hamburg noted that “regulatory science has become atrophied, particularly in comparison to biomedical research”. She emphasized that the effort to rebuild regulatory science must extend beyond FDA to universities, industry and other parts of government, including the National Institutes of Health. Several universities have developed programs in this area, including The Johns Hopkins University (JHU), which offers a Masters of Science in Bioscience Regulatory Affairs, and Northwestern University, which offers a Masters of Science in Quality Assurance and Regulatory Science. Thus, it would seem this is an especially timely moment to formalize the Track here at Yale, which has existed in a less formal way for many years as the Regulatory Affairs Program. A more formal structure will allow the Track to flourish, and to have greater visibility among the student body and hopefully to external sponsors that may be willing to offer funding to the program and for Track students such as scholarships (JHU has this arrangement currently with Becton Dickinson).

 

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NEW COURSE DESCRIPTION

This course will provide students with an introduction to regulatory affairs science, as these issues apply to the regulation of food, pharmaceuticals, and medical and diagnostic devices. All lectures will adhere to widely accepted regulatory principles, from governmental and industry sponsor viewpoints. The course covers a broad range of specialties that focus on issues including legal underpinnings of the regulatory process, compliance, phases of clinical testing and regulatory milestones, clinical trials design and monitoring, quality assurance, postmarketing study design in response to regulatory and other needs, and postmarketing risk management. The complexities of this process require awareness of leadership and change management skills. In response to these needs, topics to be discussed based on classic, widely accepted regulatory principles include: 1) the nature and scope of the International Conference on Harmonization (ICH), and its guidelines for regulatory affairs in the global environment; 2) drug development, the FDA, and principals of regulatory affairs in this environment; 3) the practice of global regulatory affairs from an industry perspective; 4) description/structure/issues of current special importance to the US FDA; 5) historical background and FDA jurisdiction of food and drug law; 6) the drug development process including specification of the investigator new drug (IND) application, the new drug application (NDA), and important milestone meetings with the FDA; 7) risk analysis and approaches to its evaluation; 8) use of Bayesian statistics in medical device evaluation — a new approach; 9) use of data monitoring committees and other statistical methods for regulatory compliance; 10) developments in leadership and change management; and 11) food quality assurance including risk analysis/compliance/enforcement. Through course participation, students also will have opportunities to meet informally with faculty and outside speakers to explore additional regulatory issues of current interest.

 

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LECTURERS Ms. Marguerite Callaway, YSPH

Dr. Paul Coplan, Executive Director, Risk Management & Epidemiology, Purdue Pharma, L.P.

Mr. Jerry Farrell, Jr., Past Commissioner of Connecticut Department of Consumer Protection

Ms. Ellen Flannery, Esquire, Partner, Covington & Burling, Washington DC

Dr. John Gadea, Jr., Connecticut Department of Consumer Protection, Drug Control Division

Mr. Frank Greene, Connecticut Department of Consumer Protection, Food and Standards

Division

Mr. Peter Barton Hutt, Esquire, Senior Counsel, Covington & Burling, Washington DC

Professor Robert Makuch, YSPH

Mr. Richard Maloney, Connecticut Department of Consumer Protection, Director of Trade

Practices

Dr. Claude Petit, Executive Director, Biostatistics and Programming, Boehringer Ingelheim

Dr. Joseph Scheeren, Senior Vice President, Head of Global Regulatory Affairs and Asia

Development, Bayer Pharmaceuticals

Dr. Thomas Schneppe, Head of Integrated Quality Management, BayerHealthCare AG

Dr. William D. Schwieterman, Chief Medical Officer, Chelsea Therapeutics

Dr. Jeffrey Sherman, Immediate Past President, DIA, and Chief Medical Officer, Horizon

Pharma

Dr. Lee S. Simon, Past Division Director, Analgesic, Anti-Inflammatory, & Ophthalmologic

Drug Product Division, CDER, FDA

Mr. John Suchy, Connecticut Department of Consumer Protection, Liquor Control Division

Dr. John Talian, Vice President, Head of US Regulatory Affairs, Bayer Healthcare

Pharmaceuticals

Mr. Nathan A. Schachtman, Esq., PC, Pharmaceutical Lawyer, Past Lecturer in Law, Columbia

Law School

 

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The  Regulatory  Affairs  Track  at  Yale  University    

BIS  575:    Introduction  to  Regulatory  Affairs  

Course  Description  

 

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INSTRUCTOR

Robert Makuch, Ph.D. 60 College Street, Room 203 robert.makuch@yale.edu TEACHING ASSISTANT

Typically will change from year to year CLASS MEETINGS

The course will meet on Thursdays from 10 am to 12 noon in LEPH (time/day proposal only-final schedule will be made that eliminates/minimizes conflict with other key courses for students in this Track). This course will be a spring semester course. OFFICE HOURS

To be announced. If you are having any difficulty, please ask the instructor for help! COURSE WEBSITE

You should register for the course on the classesv2 website (http://classesv2.yale.edu). All class materials, including the syllabus and assigned readings, will be posted there. PREREQUISITES

Students may enroll in this course if they are School of Public Health students in good academic standing at the end of their first semester in Year 1. Permission of instructor represents another alternative.

 

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1. COURSE DESCRIPTION

This course will provide students with an introduction to regulatory affairs science, as these issues apply to the regulation of food, pharmaceuticals, and medical and diagnostic devices. The course covers a broad range of specialties that focus on issues including legal underpinnings of the regulatory process, compliance, phases of clinical testing and regulatory milestones, clinical trials design and monitoring, quality assurance, post-marketing study design in response to regulatory and other needs, and post-marketing risk management. The complexities of this process require awareness of leadership and change management skills. In response to these needs, topics to be discussed include: 1) the nature and scope of the International Conference on Harmonization (ICH), and its guidelines for regulatory affairs in the global environment; 2) drug development, the FDA, and principals of regulatory affairs in this environment; 3) the practice of global regulatory affairs from an industry perspective; 4) description/structure/issues of current special importance to the US FDA; 5) historical background and FDA jurisdiction of food and drug law; 6) the drug development process including specification of the investigator new drug (IND) application, the new drug (NDA) application, and important milestone meetings with the FDA; 7) risk analysis and approaches to its evaluation; 8) use of Bayesian statistics in medical device evaluation-a new approach; 9) use of data monitoring committees and other statistical methods for regulatory compliance; 10) developments in leadership and change management; and 11) food quality assurance including risk analysis/compliance/enforcement. Through course participation, students also will have opportunities to meet informally with faculty and outside speakers to explore additional regulatory issues of current interest. 2. LEARNING OBJECTIVES

Upon completion of this course, students will be able to:

• Search for and identify relevant regulatory guidance and draft guidance documents, and utilize this information to reach science-based conclusions.

• Develop processes that will insure clear and consistent decisions to the public and to regulatory agencies.

• Assess/develop risk management strategies that can be used to get new products to the market swiftly, while assuring the consumer and regulatory bodies that efficacy and safety have been preserved.

• Develop/use leadership and management skills for conducting/overseeing research and clinical studies that are required by regulatory agencies.

 

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COURSE REQUIREMENTS/GRADING POLICY/METHODS OF STUDENT EVALUATION

1. WEEKLY READING: Readings pertinent to the topic of discussion for each week are listed at the end of the syllabus and posted on the classesv2 website. Assigned materials should be downloaded/read before class.

2. CLASS ATTENDANCE AND PARTICIPATION: Class attendance is required since classroom participation is important, and a component of the final grade for the semester. Classroom attendance/participation will account for 5% of the course grade.

3. HOMEWORK ASSIGNMENTS: There will be weekly homework assignments

during the semester based on assigned readings. The homework assignments will be graded as pass/fail and count towards class participation. The assignment will be due the next class after the assignment has been given.

4. MIDTERM EXAMINATION: There will be one take-home midterm

examination, in which open class notes/lectures/readings will be allowed. This exam will account for 45% of the course grade.

5. FINAL EXAMINATION: There will be one in-class final examination, in which

open class notes/lectures/readings will be allowed. This exam will be cumulative over the entire semester, and will account for 50% of the entire grade.

COURSE TEXTBOOK New Drug Development: A Regulatory Overview (New Drug Development) Author: Mark Mathieu Publisher: Parexel IntI. Corporation Edition: 8th revised edition 1/08 ISBN-I0: 1882615859 ISBN-13: 978-1882615858

 

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LECTURES SESSION 1 LECTURE - Dr. Robert Makuch

• Overview of the U.S. Food and Drug Administration READINGS

• Lecture slides; Course textbook: Chapters 1 and 3 SESSION 2 LECTURE - Dr. Robert Makuch

• Continued: The FDA in 2014 READINGS

• Lecture slides; “Nonsteroidal anti-inflammatory drugs and cardiovascular thrombotic risk.” Food and Drug Administration Center for Drug Evaluation and Research. Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee.

SESSION 3 LECTURE - Dr. Robert Makuch

• Continued: The FDA in 2014 READINGS

• Lecture slides; Course textbook: Chapters 2, 4, and 5 SESSION 4 LECTURE - Dr. Robert Makuch

• The “NDA” Process in Europe: The Marketing Authorization Application (MAA) Process

READINGS • Lecture slides

SESSION 5 LECTURE – Dr. Claude Petit

• Non-Inferiority Clinical Trials Based Upon FDA Guidance for Industry Non-Inferiority Clinical Trials

• FDA-EMA Similarities and Differences READINGS:

• Lecture slides; Course textbook: Chapters 2, 6, and 7; Guidance for Industry Non-Inferiority Clinical Trials

SESSION 6 LECTURE - Dr. Robert Makuch

• Data Monitoring Committees and Their Duties/Responsibilities READINGS:

• Lecture slides; Course textbook: Chapters 8 and 10 SESSION 7 LECTURE - Dr. Robert Makuch

• The FDA Focus on Safety: An Overview, the GAO Report, PDUFA IV, and Labelling

 

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READINGS: • Lecture slides; Chapters 11 and 13

SESSION 8 LECTURE - Dr. Joseph Scheeren

• Overview of Regulatory Environment in China READINGS:

• Lecture slides; SESSION 9 LECTURE - Dr. Lee S. Simon

• An Analysis of Risk: An Approach to Determine Risk in the Post-marketing Environment READINGS:      

• Lecture slides; Course textbook: Chapters 9, 12, 14, and 15

   3. NUMBER OF HOURS OF CLASSROOM TIME/WEEK

This number of hours in the classroom per week will allow the students adequate lecture time, and at the same time prepare them for the extensive readings. The readings selected will require 6 hours/week on average, since they contain a great deal of useful and detailed information that can be learned only through quiet contemplation. 4. LECTURERS

Lecturers are carefully selected, both for their in-depth direct knowledge in the areas they are lecturing on, and for their broad knowledge in development of compounds and devices. These senior people also will come and visit with the students before/after their lecture, to provide an informal opportunity for further discussion and future placement possibilities. The growing list of lecturers for this course is provided earlier in this report.

 

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5. COURSE LEARNING OBJECTIVES AND METHODS OF STUDENT EVALUATION

Course Learning Objectives Evaluation Method

Homework Midterm Final Search for and identify relevant regulatory guidance and draft guidance documents and utilize this information to reach science-based conclusions.

X X   X  

Develop processes that will insure clear and consistent decisions to the public and to regulatory agencies.

X X   X  

Assess/develop risk management strategies that can be used to get new products to the market swiftly, while assuring the consumer and regulatory bodies that efficacy and safety have been preserved.

X X  

Develop/use leadership and management skills for conducting/overseeing research and clinical studies that are required by regulatory agencies.

X  

           

 

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The  Regulatory  Affairs  Track  at  Yale  University  

Future  Growth  and  Needs  

 

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FUTURE GROWTH OF THE REGULATORY AFFAIRS TRACK

The Regulatory Affairs Track began in the early 1990s, through a 3-year initial start-up unrestricted grant from The Proctor and Gamble Company. This places the Track’s initiation within a graduate-level program, as the first of its kind in the United States and Europe.

Today, the Track’s achievements include: 1) review and acceptance by Yale University of the Track as a formal academic entity with entry requirements and certification upon satisfactory completion of Track course requirements; 2) teaching at the graduate level a new introductory course on regulatory affairs; and 3) multiyear training to senior delegations from the Chinese SFDA. It is our goal to obtain additional sources of funding that would allow the Track to grow in these areas, and to enable Yale to be identified as a leader in the area of regulatory affairs science.

To continue and to enhance these activities, we seek funding in several areas, including:

1. Additional support of the Track Director, Dr. Robert Makuch, who has overseen the Regulatory Affairs Track since its inception.

2. New support for Yale faculty such as faculty from the Law School for the development of new courses that will enrich the current Track.

3. Funding for partial tuition support for students in the Track. 4. Funding for travel to professional society meetings by both students and faculty. 5. Providing adequate administrative support to Faculty, and to students for summer

internship placements and identification of permanent positions upon their graduation from Yale University.

Multi-year funding in the 3 to 5 year range would allow proper development and implementation of strategic plans. If there are further questions or suggestions, please contact Dr. Makuch directly: Robert W. Makuch, Ph.D. Professor, Biostatistics Director, Regulatory Affairs Track Yale University School of Medicine Department of Epidemiology and Public Health PO Box 208234 New Haven CT 06520-8234 courier 60 College Street, 203 LEPH New Haven CT 06510 T 203 785-2842 F 203 785-6912 robert.makuch@yale.edu

 

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The  Regulatory  Affairs  Track  at  Yale  University    

Graduates

 

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2011 Graduates of the Regulatory Affairs Track at Yale University

Debbie Chin, MPH

Xiangyu Cong, PhD, MPH

Kate Corvese, MPH

Whitney Hubbard, MPH

Nita Mehta, MPH

Sara Neuman, MPH

Peter Spain, MPH

Kyle Walsh, PhD

Miao Yu, MPH

2012 Graduates of the Regulatory Affairs Track at Yale University

Anita Sung, PhD

Jingni Xie, MPH

Gyeyoon Yim, MPH

Kathy Xiaoxi Zheng, MPH  

 

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2013 Graduates of the Regulatory Affairs Track at Yale University

Courtney Armstrong, MPH

Mitra Daneshvar, MPH

Neel Iyer, MPH

Katherine Gendreau, MPH

Shan Jiang, MPH

Raj Kumar, MPH

Eugene Lee, MPH

Mark Lerchenmueller, MPH

Ying Liu, MPH

Christian Ramos, MPH

Ilya Slizovskiy, MPH

Mary Traglia, MPH Jing Yang, MP Lu Zhou, MPH

 

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2014 Graduates of the Regulatory Affairs Track at Yale University

Rachel Bhak, MS

Chin Hee Chung, MPH

Christine Oscai, MPH

Ziyi Li, MPH

Ji Young Kwon, MPH

Susan Jin, MPH

Aliyar Fouladkhah, MPH

Amaka Ezeoke, MPH

Amy He, MPH

Qiao Chu Qi, MPH

Sisi Wang, MPH

Geliang Gan, MPH

 

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Tiffany Elizabeth Chang, MPH

Taylor Robert Daily, MPH

Jina Li, MPH

Justin Derald Mendoza, MPH

Lan Min, MS

Oladoyin Adewuyi Oladeru, MPH

Hongjin Yan, MPH

Qi Yang, MPH

Hua, Zeng, MPH

Fan Zhang, MPH

2015 Graduates of the Regulatory Affairs Track at Yale University