Northeastern University College of Professional Studies Course Syllabus Department of Regulatory Affairs

Transcription

1 Northeastern University College of Professional Studies Course Syllabus Department of Regulatory Affairs CRN: Course: RGA6222: European Medical Device Regulations Fall 2015, 12 week, full term September 21, 2015 December 19, 2015 Course Format: Virtual Meeting Time: Online, no specific meeting time Note: For courses meeting on campus, room assignments will be available online by the start of term in MyNEU/Self Service Banner. Instructors Note: You can find term dates with your contract documents or on the Registrar website/calendar page: Instructor Name: Jocelyn Jennings NEU Phone Number: available upon request Please contact me via . I will respond within 48 hours to your initial inquiry. Telephone discussions can be scheduled by arranging a time with me through . Required Text(s)/Software/Tools: There will not be a required text for this course. This course contains audio material and in some instances, you may be asked to participate in audiobased activities, such as a Voice Discussion A headset (headphones plus microphone) will allow you to hear and record audio. The Logitech ClearChat Comfort USB Headset, or the Plantronics Audio 470 or 500, or comparable brands/models, are recommended. Headsets can be purchased from online vendors such as amazon.com, bestbuy.com, or newegg.com. Recommended Textbooks/Resources: Book title: Global Medical Device Regulations Author/Publisher: RAPS ( Edition and Year: 1st edition, 2014 ISBN: Turabian, Kate L. et al. (2013). A Manual for Writers of Research Papers, Theses, and Dissertations: Chicago Style for Students and Researchers (8 th ed.). Chicago: University Of Chicago Press. [ISBN: ] Or APA. (2009). Publication Manual of the American Psychological Association (6th ed.). Washington, D.C.: American Psychological Association. Northeastern University: College of Professional Studies

2 [ISBN: ] 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 6222 prerequisites: 6202, 6205 and 6220 Course Description This course covers European Commission directives and guidance documents; European Agency for the Evaluation of Medicinal Products, medical device guidance and notified body guidelines and recommendations; Global Harmonization Task Force final reports; and mutual recognition agreements. Topics include biological and biotechnological products, CE marking, conformity assessment and notified bodies, the Global Harmonization Task Force, clinical trials, and standardization. Course Outcomes Identify and summarize information available on the European Medicines Agency (EMA) website for medical devices including active implantable and in vitro diagnostic medical devices Describe critical events in the history of the EMA and the medical device regulations Describe the different conformity assessments for medical devices Identify and explain the role and requirements for conducting clinical studies to support technical dossiers and post-approval product modifications 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 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 Northeastern University: College of Professional Studies 2

3 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. For Discussion Boards it is expected that the question asked is answered in the student s own words. Rewriting regulations or lecture material is not an acceptable answer for graduate level work. The Discussion Board questions are designed to provoke critical thinking about the material presented in the lecture materials. The goal is for you to understand the regulations and look at them from different points of view. Discussion Board responses that do not answer the specific question asked, contain the regulations verbatim or are not substantive will receive a grade of zero (0). An example of a post that is not substantive is stating I agree, I liked your point, Good point, etc. These posts will not be counted as a secondary post unless there is substantive discussion included along with these comments. The primary post is due by Wednesday at 11:59pm EDT of each week. Two secondary posts are due by Sunday.at 11:59pm EDT. Additional Considerations: Students are responsible for any communications sent to their official, NEU-husky 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 ( 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, s, discussion board and water cooler posts or other instructions from the instructor or teaching assistant. Communication/Submission of Work Northeastern University: College of Professional Studies 3

4 In the Assignments folder, click on the View/Complete Assignment link to view 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. If you come across papers, websites or other information of interest, please post it in the Discussion Board in the Water Cooler. If you have specific questions regarding the Discussion Board, Assignments, Homework, Quiz or Exams, etc., direct them to me via . Make sure that you include the following in the subject line: RGA 6222, CRN and the topic. 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 (nuonline@neu.edu or 24/7 Phone support at ) and the instructor should be notified immediately and the 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. Late Assignment policy: 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 Points/Percentage Due Date Discussion Board 10% Weekly Quizzes 15% Per the schedule Writing Assignment 1 20% Per the schedule Midterm Examination 25% Per the schedule Final Examination 25 % Per the schedule Writing Assignment This writing assignment will be worth 20% of your final grade. Each student will submit an Essential Requirements Checklist for a medical device, active implantable or in vitro diagnostic medical device. The ER checklist should include a Northeastern University: College of Professional Studies 4

5 representation of the relevant standards, guidance and directives for the medical device chosen. The checklist will follow the medical device directive specific to the chosen medical device therefore no maximum pages will be specified. However the ER checklist should be at least two pages in length. The assignment is due Saturday, November 21, 2015 at 11:59 p.m. EDT. The assignment must be submitted via the Turnitin link in the Week 9 assignment folder. Midterm Exam The midterm exam will be worth 25% of your final grade. This exam will test your knowledge of what you learned from Week 1-6. The exam will consist of multiple choice, true/false and short answer questions. The exam will be timed and multiple attempts will not be allowed. Final Exam The final exam will be worth 25% of your final grade. The Final Exam will cover materials from Weeks 1 through 12 with emphasis on Weeks The exam will consist of multiple choice, true/false and short answer questions. The exam will be timed and multiple attempts will not be allowed. 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 using the following scale: % A % A % B % B % B % C % C % C % or below F 0.0 Please note that 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. Class Schedule / Topical Outline Week 1 9/21-9/27 Weekly Topic(s) EU Regulatory Affairs-Historic Perspective Weekly Outcomes Describe critical milestones in the history of European medical device regulations Identify the main EU Directives governing medical devices Describe the purpose of the IMDRF Readings and Lectures Discussion Board, Assignments and Assessments Northeastern University: College of Professional Studies 5

6 articles, EU guidance 2 9/28-10/4 Last day to drop without a W: Oct 4th 3 10/5-10/ / /19-10/25 The European Medical Devices Legal System Classification of Medical Devices Technical Requirements for Conformity Assessment Clinical Evaluation of Medical Devices Gain insight into the European legislative process Describe the basic legal requirements for medical devices Identify the available guidance concerning the requirements for medical devices Identify the key concepts of medical device classification Describe the classification rules for medical devices Describe the reclassification process Understand the technical requirements needed to demonstrate conformity to Essential Requirements Describe the role of international standards in the conformity assessment process Describe the basic contents of the technical documentation file Describe the requirements for clinical evaluations in the EU Describe the different routes for providing clinical evaluations Describe the differences in clinical evaluations between medical devices, active implantable medical devices and in vitro medical devices Quiz 1 (will cover Week 1 and Week 2) Quiz 2 (will cover Week 3 and Week 4) 6 10/26-11/1 Conformity Assessment Procedures Quality System Requirements Midterm Exam Describe the conformity assessment procedures and the similarities between directives Describe Notified Body involvement in the conformity assessment process No Discussion Board Midterm will be due on November 1, 2015 at 11:59 p.m. EDT Midterm will consist of no more than 30 short answer, true/false, multiple choice, fill in the Northeastern University: College of Professional Studies 6

7 Describe the relationship of the conformity assessment procedures to the quality system standard Describe the role of the Authorized Representative in the conformity assessment process blanks questions and short essays. The Midterm will cover materials from Weeks 1 through 6. Midterm will be timed and multiple attempts will not be allowed. 7 11/2-11/8 8 11/9-11/ /16-11/22 Active Implantable Medical Devices In Vitro Diagnostic Medical Devices Labeling Describe the Active Implantable Medical Device Directive Describe the regulatory process by active implantable medical device manufacturers Describe the In Vitro Diagnostic Medical Device Directive Describe the regulatory process to be followed by in vitro diagnostic medical device manufacturers Describe the proposed RECAST regulations Describe the labeling standards for medical devices Identify the new GHS labeling standards and symbols Quiz 3 (will cover Week 7 and Week 8) Assignment 1 Each student will submit an Essential Requirements Checklist for a medical device, active implantable or in vitro diagnostic medical device. The ER checklist should include a representation of the relevant standards, guidance and directives for the medical device chosen. The checklist will follow the medical device directive specific to the chosen medical device therefore no maximum pages will be specified. However the ER checklist should be at least two pages in length. The assignment is due Saturday, November 21, 2015 at 11:59 p.m. EDT. The assignment must be submitted via the Turnitin link in the Week 9 assignment folder. 11/23-11/29 Thanksgiving Holiday Recess No class 10 11/30-12/6 Medical Device Compliance: Postmarket Requirements Describe the requirements for manufacturers concerning postmarket surveillance procedures Describe the European vigilance system for medical devices Identify the requirements for Quiz 4 (will cover Week 9 and Week 10) Northeastern University: College of Professional Studies 7

8 incident reporting 11 12/7-12/13 National Requirements for medical devices Describe the notification process to competent authorities for medical devices Describe national provisions for marketing, sales and distribution organizations and personnel Describe national provisions in clinical development 12 12/14-12/19 Software Final Exam You can find term dates with your contract documents or on the Registrar website/calendar page. Academic Integrity Policy Describe the process to determine if software is a medical device Identify specific regulatory issues associate with software Describe the design and quality system requirements for software Wednesday). This could be a Voice Discussion Final Exam will be due on December 19, 2015 at 11:59 p.m. EDT The Final Exam will consist of no more than 40 short answer, true/false, multiple choice, fill in the blanks questions and short essays. The Final Exam will cover materials from Weeks 1 through 12 with emphasis on Weeks The Final Exam will be timed and multiple attempts will not be allowed. 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 Northeastern University: College of Professional Studies 8

9 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 Northeastern University Online Policies and Procedures For comprehensive information please go to Northeastern University Online Copyright Statement Northeastern University Online is a registered trademark of Northeastern University. All other brand and product names are trademarks or registered trademarks of their respective companies. This course material is copyrighted and Northeastern University Online reserves all rights. No part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval system, or translated into any language or computer language, in any form or by any means, electronic, mechanical, magnetic, optical, chemical, manual, or otherwise, without the express prior written permission of Northeastern University Online. Copyright by Northeastern University Online All Rights Reserved Instructor s Biographical Sketch Northeastern University: College of Professional Studies 9

10 Jocelyn Jennings, MS, RAC is a regulatory affairs professional working for a global in vitro diagnostic medical device company. Ms. Jennings has over 17 years of extensive global regulatory affairs, quality assurance and global clinical trial experience in drugs, biologics and medical devices. Ms. Jennings is also actively involved with the Regulatory Affairs Professional Society (RAPS) writing chapters for their regulatory books and writing online courses. Ms. Jennings obtained her BS degree in Biology from Notre Dame College, her MS in Regulatory Affairs from Northeastern University and has her Regulatory Affairs Certification. Recommended Writing Resources: Northeastern University Tutoring Services: Services include Tutoring Center, Writing Center, and Smarthinking available to online and on-ground students Northeastern University Academic Integrity page: Purdue University Online Writing Lab Purdue University (2014). Purdue University Online Writing Lab (OWL). Available: Northeastern University: College of Professional Studies 10