CRN: 70100 Course: RGA 6201 New Drug Development: A Regulatory Overview Fall 2017, 13-week term September 18 – December 17, 2017 Course Format: On Campus Meeting Time: Thursday, 17:50-20:30 (5:50 – 8:30 pm) Note: For courses meeting on campus, room assignments will be available online by the start of term in MyNEU/Self Service Banner.
Please contact me using email. I will respond within 48 hours.
Required Text(s)/Software/Tools
Fundamentals of US Regulatory Affairs
Published by: Regulatory Affairs Professionals Society
Edition/Copyright: 8th Edition/2013
ISBN-10: 0982932065; ISBN-13: 978-0982932063
Recommended Textbooks/Resources Turabian, Kate L. et al. (2013). A Manual for Writers of Research Papers, Theses, and Dissertations: Chicago Style for Students and Researchers (8th ed.). Chicago: University Of Chicago Press. [ISBN: 978-0226823379] Or APA. (2009). Publication Manual of the American Psychological Association (6th ed.). Washington, D.C.: American Psychological Association. [ISBN: 978-1-4338-0561-5]
Course Prerequisites
If a student has not fulfilled the pre-requisite course requirements, he or she will not be able to register for a course. RGA 6201 prerequisites: none, but completion of RGA 6000 or commensurate experience strongly recommended.
Course Description
Examines every step of the drug development and regulation process, from preclinical testing through postmarketing adverse experience reporting. Considers FDA standards for nonclinical testing-quality assurance issues and good laboratory practice, investigational new drug application (NDA) and review process initiatives designed to speed drug review, and the Prescription Drug User Fee Act (PDUFA).
Successful completion of the course should enable students to:
Describe which divisions of the US Food and Drug Administration (FDA) are involved in
regulating the commercialization of new drug products in the US market.
Distinguish how pharmaceutical product types are differentiated from medical device and
biologic products, as defined by the Food, Drug and Cosmetic Act
Explain the following aspects of the new drug product US commercialization process:
- The drug product development process
- The regulatory processes involved in clinical assessment of new drug products
- The role of manufacturing and quality assurance in the commercialization of new
drug products
Detail the following regulatory milestones in the drug product commercialization process:
- Regulatory requirements before initiating trials in humans
- Filing of an Investigational New Drug Application (IND) with the FDA to initiate clinical
trials
- Regulatory requirements to conduct trials in accordance with Good Clinical Practices
(GCPs)
- Filing of the New Drug Application (NDA) and Common Technical Document (CTD)
with the FDA to obtain marketing approval
Course Methodology
Each week, you will be expected to:
1. Review the week's learning objectives 2. Complete all assigned readings 3. Complete all lecture materials for the week 4. Participate in the Discussion Board 5. Complete and submit all assignments and tests by the due dates 6. Proactively contact the instructor with any questions or concerns
Participation/Discussion Board
Students are responsible for any communications sent to their official, NEU-husky e-mail account.
Active participation in regulatory affairs courses is defined by both the quantity and quality of
contributions. You are expected to have completed the reading and lecture material, and any
assignments prior to class and given the content considerable thought. Your contributions must be
submitted by stated deadlines unless other arranged beforehand.
High quality contributions advance the class discussions and do not simply summarize the material that was assigned. Quality contributions take into account not only the instructors’ questions but also your classmates’ contributions.
When participating in class, students are expected to be polite, respectful of other students and the instructor, and to contribute to the course at a level fitting of a graduate-level program. The instructor reserves the right to penalize students for repeated violations of the participation policy within a course.
In the discussion board and in class, high quality contributions advance the class discussions and do not simply summarize the material that was assigned. Quality contributions take into account not only the instructor’s questions but also your classmates’ contributions.
Additional Considerations Students are responsible for any communications sent to their official, NEU-husky e-mail account.
Attendance Policy In both on-ground and online courses, you are expected to attend all classes and discussions for the entire length of term. In addition, you will also be expected to complete assignments and group projects outside of class. Students may be penalized for all unexcused absences. The University does allow for certain types of excused absences (http://www.cps.neu.edu/student-resources/images/CPS-Stu-Handbook2013-2014.pdf). However, you will be expected to notify your instructor at least 48 hours in advance for all absences from class. Approval for absences is at the instructor's discretion. In the case of a missed course or excused absence, including during the add-drop period, students are expected to make arrangements with the instructor to make up all materials in a timely fashion.
Tardiness Policy In courses which meet in person, students may be marked down for lateness to class at the discretion of the instructor. Students should make all possible attempts notify the instructor at least 48 hours before missing a course meeting. Online students are expected to participate regularly and punctually in their online course and are responsible for all deadlines course announcements, e-mails, discussion board and water cooler posts or other instructions from the instructor or teaching assistant.
Communication/Submission of Work
In the Assignments folder, click on the View/Complete Assignment link to view and each assignment. Attach your completed assignments here and click Submit to turn them in to me. Once your assignment has been graded, you will be able to view the grade and feedback I have provided by clicking on My Grades in the Tools module from the Northeastern University Online Campus tab. In most cases, your written work will be reviewed by TurnitIn® in order to check for originality and correct citation practices. Additionally, your instructor or TA may request a printed paper copy for his or her records.
Online Assessments
In the case of online assessments, all of the general grading particulars apply. In addition, students are expected to be familiar with taking exams on Blackboard. They should consult with Blackboard Technical Help if additional support is required. A guidance document will be provided for students to read prior to launching each assessment. The document explains the reset policy and all expectations regarding taking quizzes and exams. Students are expected to read the document and ask any questions regarding the policies prior to launching the quiz / exam on Blackboard.
Technical Issues In the case of technical issues for online assignments, NUOnline ([email protected] or 24/7 Phone support at 1-855-836-3520) and the instructor should be notified immediately and the e-mail and help-ticket reference case retained. Please note, technical issues are not a sufficient excuse for missing deadlines, therefore students may or may not receive credit for late material at the discretion of the instructor.
A deduction of 20% percent will be made for each day that an assignment is late. Work will no longer be accepted 3 days after the specified deadline, unless specific arrangements have been made with the instructor.
Grading/Evaluation Standards
Deliverable Points/Percentage Due Date
Participation/Discussion
Board Topics
20% Weekly participation in class and Discussion Board
Topics
Discussion Board Topic 1 – October 6
Discussion Board Topic 2 – November 3
Discussion Board Topic 3 – December 8
Discussion Board Topic 4 – December 15
Quizzes
20%
Quiz 1 – October 5
Quiz 2 – October 12
Quiz 3 – October 19
Quiz 4 – October 26
Quiz 5 – November 2
Quiz 6 – November 16
Quiz 7 – November 30
Quiz 8 – December 7
(in class)
Writing Assignments 30% Writing Assignment 1 – September 29
Writing Assignment 2 – October 13
Writing Assignment 3 – October 27
Writing Assignment 4 – November 10
Writing Assignment 5 – December 1
(submit online to Turnitin)
Final Exam 30% December 16
(submit online to Turnitin)
TOTAL 100%
Exams and quizzes may consist of fill-in the blanks, multiple choice, matching, short answer and/or short essay questions. In the case of a timed assessment, it is expected that the assignment to be completed within the given period and number of sittings allowed by the instructor. Examinations and assessments may take place in class or online.
Quizzes In-class administered at the beginning of class, covering content from the
previous week; may consist of fill-in the blank or short answer questions. Time
limit: 10 minutes
Writing Assignments
2 - 3 page paper based on a topic given in class by the instructor.
The paper should be written in Times New Roman or Arial in font size
11, with 1-inch margins around the paper. Please refrain from using borders.
Include proper citations. More details will be provided in class.
Study Guides Study Guides are provided on Blackboard. There will be no due dates for the
Study Guides.
Final Exam Take-home exam taken during the final week (Week 12). May consist of fill-in the
blank or short answer questions. Include proper citations. More details will be
provided in class.
Participation Measured by punctual attendance and engagement with lectures and classroom
activities.
Grading Explanation
Please see the course’s Blackboard site for any rubrics or grading explanations specific to this course. Academic honesty standards will be strictly enforced by the instructor and the department.
Grading Scale The grades will be broken down by the following scale:
95-100% A 4.0
90-94.9% A- 3.7
87-89.9% B+ 3.3
84-86.9% B 3.0
80-83.9% B- 2.7
77-79.9% C+ 2.3
74-76.9% C 2.0
70-73.9% C- 1.7
69.9% or below F 0.0
Please remember, each student’s performance in a given course will be evaluated independently of the quality or work completed for- or the grade he or she has earned in other courses.
Week Weekly Topics Weekly Outcomes Readings and Lectures Discussion Board, Assignments and Assessments
Week 1 9/18/ – 9/24
Introduction to the Drug Development Process
Describe the general stages of drug development from R&D to marketing
Explain the purpose of Good Laboratory Practices (GLP’s)
List the various types of manufacturer – FDA interactions that can and should occur during the drug development process
Explain how the US Food and Drug Administration (FDA) fulfills its mission in protecting the public health
Discuss key legislative milestones driving the evolution of US pharmaceutical regulation
Understand the rulemaking process by which new regulations are established
Textbook Chapters 1, 2, and 3
Writing Assignment 1 due 9/29 (Guidance on a Guidance)
.
Week 2 9/25 – 10/1
Drugs, their Targets, and the Dynamics of Drug Activity
Describe the general process by which new molecular entities (NME's) are identified, both through traditional "pharma" based approaches and through the use of biotechnology
Understand what a drug is and how it can impact cellular behavior and function
Define a drug target while understanding the nature of drug-target
interactions that elicit or inhibit biological responses
Describe the various ways drugs can impact the activity of their targets, for example, through activation or disruption of signal transduction or receptor signaling
Explain the four fundamental pathways of drug disposition and understand how each is linked to drug action
List the criteria of an ideal drug
Week 3 10/2 – 10/8
Nonclinical Development and Good Laboratory Practices
Identify the non-clinical required components of drug approval application process
Describe the purposes of the various nonclinical studies, as well as their potential timing during drug development
Understand why it would be very unlikely for any two nonclinical development programs to be exactly the same
Explain the fundamental aspects of Good Laboratory Practice while understanding the innate risks associated with clinical development
Explain the origins and basic elements of Good Clinical Practice (GCP) while recognizing the regulations within 21 CFR that enforce GCP standards
Understand the various goals and potential timing of each clinical trial phase
Describe the range of documents generated to allow evaluation of GCP compliance
List the major pharmaceutical market segments and communicate an understanding of differences between them in terms of time and cost to bring drug products to market in these segments
Week 7 10/30 – 11/5
New Drug Application
Explain the NDA submission process
State the objective of a pre-NDA meeting with FDA
Identify the components of a complete New Drug Application (NDA) and define the contents and purpose of each section
Explain the initial NDA submission and review processes, as well as the possible FDA review outcomes
Discuss the impact of the Prescription Drug User Fee Act (PDUFA) on NDA review timelines
Describe postmarketing requirements necessary to maintain an approved NDA, including post-approval
Overview of Prescription Drug Labeling and Advertising Requirements
Describe the importance of labeling, particularly for prescription and over-the-counter drugs
Explain the difference between a drug label and drug labeling
Understand the scope of regulatory authority over prescription drug labeling for investigational medicinal products in the US and EU and marketed products in the US and EU
Learn the general FDA requirements for the advertising and promotion of prescription drugs
Describe the mission of the Office of Prescription Drug Promotion in the regulation of promotional materials
Textbook Chapter 16
Writing Assignment 5 due 12/1 (NDA Consulting)
Quiz 6 in class 11/16
Week 10 11/20 – 11/26
Thanksgiving Break No Class
Week 11 11/27 – 12/3
Generic and Over-the-Counter Drugs, and Good Manufacturing Practices
Describe the difference between brand name and generic drugs while understanding the concepts of bioequivalence and therapeutic equivalence
Discuss FDA’s generic drug approval process and requirements
Understand how the generic drug industry has benefited the public,
increased FDA’s responsibilities in both complexity and magnitude, and how the FDA has responded to the evolution and globalization of the generic drug industry
Discuss the regulations surrounding over-the-counter (OTC) drugs as well as the criteria for defining and labeling OTC drugs
Provide an overview of the most significant elements of Good Manufacturing Practices (GMP) impacting drug development and manufacturing
Week 12 12/4 – 12/10
Drug Development Incentives for Rare Diseases, Serious Indications, and Special Populations
List the components of each type of expedited NDA review program
State the objectives of an expedited NDA review
Define the challenges associated with drug development for pediatrics and geriatrics
Describe the FDA’s Fast Track, Accelerated Approval, and Breakthrough Programs
Understand the importance of genetic subpopulation identification while recognizing its impact on drug development regulation
You can find term dates with your contract documents or on the Registrar website/Calendar page. http://www.northeastern.edu/registrar/calendars.html
Academic Integrity Policy
The University views academic dishonesty as one of the most serious offenses that a student can commit while in college and imposes appropriate punitive sanctions on violators. Here are some examples of academic dishonesty. While this is not an all-inclusive list, we hope this will help you to understand some of the things instructors look for. The following is excerpted from the University’s policy on academic integrity; the complete policy is available in the Student Handbook. The Student Handbook is available on the CPS Student Resources page > Policies and Forms. Cheating – intentionally using or attempting to use unauthorized materials, information or study aids in an academic exercise
Unauthorized use of notes, text, the Internet, or other aids during an examination.
Copying from another student’s academic work.
Unauthorized communication during an examination.
Handing in the same paper for more than one course without explicit permission from the instructor(s).
Fabrication – intentional and unauthorized falsification, misrepresentation, or invention of any data, or citation in an academic exercise Plagiarism – intentionally representing the words, ideas, or data of another as one’s own in any academic exercise without providing proper citation
Word-for-word quotations from a source, including another student’s work.
Paraphrasing (using the ideas of others in your own words).
Unusual or controversial facts not widely recognized.
Audio, video, digital, or live exchanges of ideas, dialogues, or information. Additionally, the Regulatory Affairs Department and its instructors would like to remind all students that proper citation requires both quotation marks and thoroughly documented references:
1. When writing, if using someone else’s exact words, these words, phrases, sentences, paragraphs, etc. must be enclosed in quotation marks and their source be properly cited in parenthetical documentation, footnote, or endnote format as specified by the instructor. Any use of the words of another person without quotation marks will be considered academically dishonest.
2. Any use of the idea of another person, even if paraphrased by the student author, must be marked by proper citation, whether parenthetical documentation, footnote, or endnote format as specified by the instructor. The use of the idea of another author without proper citation will be considered academically dishonest.
Unauthorized collaboration – instances when students submit individual academic works that are substantially similar to one another; while several students may have the same source material, the analysis, interpretation, and reporting of the data must be each individual’s independent work. Participation in academically dishonest activities – any action taken by a student with the intent of gaining an unfair advantage Facilitating academic dishonesty – intentionally or knowingly helping or attempting to violate any provision of this policy For more information on Academic Integrity, including examples, please refer to the Student Handbook, pages 9-11.
Instructor Biographical Sketch Thomas Koperniak, Ph.D., RAC is a Global Regulatory Lead at GE Healthcare, with over 8 years of domestic and international experience spanning research, development, and commercial operations across multiple therapeutic areas. He was previously a Regulatory Affairs Specialist at FORUM Pharmaceuticals, supporting early and late stage clinical development programs. Prior to working in Regulatory, he supported in vivo pharmacology at FORUM by contributing to pharmacokinetic, behavioral, and tolerability studies for preclinical screening of compounds aimed at treating various CNS disorders. Tom holds a Ph.D. in Pharmacology from Northeastern University, a B.A. in Chemistry from Williams College, and has maintained U.S. Regulatory Affairs Certification since 2011.
Recommended Writing Resources Northeastern University Tutoring Services: http://www.cps.neu.edu/student-resources/tutoring-services.php Services include Tutoring Center, Writing Center, and Smarthinking – available to online and on-ground students Northeastern University Academic Integrity page: http://www.cps.neu.edu/student-resources/academic-integrity.php Purdue University Online Writing Lab Purdue University (2014). Purdue University Online Writing Lab (OWL). Available: https://owl.english.purdue.edu/owl/
