RWC716 - Regulatory Writing and Communications
| Semester | |
| School | |
| Last revision date | 2024-01-29 01:11:41.338 |
| Last review date | 2024-02-05 00:15:07.978 |
Subject Title
Regulatory Writing and Communications
Subject Description
The focus of this subject is on communication with peers and regulatory agencies. Students acquire the competencies needed to prepare regulatory communications and transact the business of quality assurance by examining the practices used to gather and communicate information and improve organizational effectiveness. Aspects of interpersonal communication, such as the use of interviews and meetings to gather information, are explored.
Credit Status
This is a credit toward the Ontario College Graduate Certificate Program in Pharmaceutical Regulatory Affairs and Quality Operations offered through the School of Biological Sciences and Applied Chemistry and the Faculty of Continuing Education and Training.
Learning Outcomes
Upon successful completion of this subject the student will be able to:
- Write clearly and correctly for the pharmaceutical business environment
- Match communications with the intended audience
- Present written information logically and clearly
- Prepare communications related to the pharmaceutical regulatory environment (submission cover letters, Clarifax responses, responses to warning letters, requests for meetings with Health Canada)
- Respond verbally and non-verbally in an appropriate professional manner to given case scenarios from the pharmaceutical manufacturing industry
- Write in compliance with GMPs
- Differentiate between appropriate writing styles in emails and in letters
- Detect errors in written communications
- Interpret written technical communications
- Create/review pharmaceutical promotional materials to ensure compliance with Canadian laws and regulation
Academic Integrity
Seneca upholds a learning community that values academic integrity, honesty, fairness, trust, respect, responsibility and courage. These values enhance Seneca's commitment to deliver high-quality education and teaching excellence, while supporting a positive learning environment. Ensure that you are aware of Seneca's Academic Integrity Policy which can be found at: http://www.senecapolytechnic.ca/about/policies/academic-integrity-policy.html Review section 2 of the policy for details regarding approaches to supporting integrity. Section 2.3 and Appendix B of the policy describe various sanctions that can be applied, if there is suspected academic misconduct (e.g., contract cheating, cheating, falsification, impersonation or plagiarism).
Please visit the Academic Integrity website http://open2.senecac.on.ca/sites/academic-integrity/for-students to understand and learn more about how to prepare and submit work so that it supports academic integrity, and to avoid academic misconduct.
Discrimination/Harassment
All students and employees have the right to study and work in an environment that is free from discrimination and/or harassment. Language or activities that defeat this objective violate the College Policy on Discrimination/Harassment and shall not be tolerated. Information and assistance are available from the Student Conduct Office at student.conduct@senecapolytechnic.ca.
Accommodation for Students with Disabilities
The College will provide reasonable accommodation to students with disabilities in order to promote academic success. If you require accommodation, contact the Counselling and Accessibility Services Office at ext. 22900 to initiate the process for documenting, assessing and implementing your individual accommodation needs.
Camera Use and Recordings - Synchronous (Live) Classes
Synchronous (live) classes may be delivered in person, in a Flexible Learning space, or online through a Seneca web conferencing platform such as MS Teams or Zoom. Flexible Learning spaces are equipped with cameras, microphones, monitors and speakers that capture and stream instructor and student interactions, providing an in-person experience for students choosing to study online.
Students joining a live class online may be required to have a working camera in order to participate, or for certain activities (e.g. group work, assessments), and high-speed broadband access (e.g. Cable, DSL) is highly recommended. In the event students encounter circumstances that impact their ability to join the platform with their camera on, they should reach out to the professor to discuss. Live classes may be recorded and made available to students to support access to course content and promote student learning and success.
By attending live classes, students are consenting to the collection and use of their personal information for the purposes of administering the class and associated coursework. To learn more about Seneca's privacy practices, visit Privacy Notice.
Prerequisite(s)
Co requisite
PRA700 - Introduction to Pharmaceutical Regulatory Affairs and/or co-ordinator permission
Topic Outline
Written Communications
- Letters (purpose, format, e.g., to meet regulatory requirements, correspondence, resume cover letter)
- Clarity, accuracy and appropriateness
- Conciseness and completeness
- Conveying the correct information
- Knowing your audience
- Regulatory requirements (e.g., response to a Clarifax and audit from Health Canada; request for a pre-NDS meeting)
- Product Monograph
- Checking spelling and grammar
- Overall presentation
- Advertising and labeling (e.g., draft letter to superiors to dispute competitors’ advertising as per Advertising Standards Canada procedures; reviewing and revising pharmaceutical promotional materials)
Unwritten Communications
- Presentation skills and style
- Knowing your audience
- Communication styles
- Body language
- Effective listening
Mode of Instruction
Primarily lecture with significant group discussion and assignments
Prescribed Texts
None
Reference Material
A Canadians Writer's Reference, 4th Edition; Diana Hacker; Bedford / St. Martin's Publisher, 2007 ISBN: 0-312-47283-8
A good Dictionary and Thesaurus
Required Supplies
None
Student Progression and Promotion Policy
http://www.senecapolytechnic.ca/about/policies/student-progression-and-promotion-policy.html
Grading Policyhttp://www.senecapolytechnic.ca/about/policies/grading-policy.html
| A+ | 90% to 100% |
| A | 80% to 89% |
| B+ | 75% to 79% |
| B | 70% to 74% |
| C+ | 65% to 69% |
| C | 60% to 64% |
| D+ | 55% to 59% |
| D | 50% to 54% |
| F | 0% to 49% (Not a Pass) |
| OR | |
| EXC | Excellent |
| SAT | Satisfactory |
| UNSAT | Unsatisfactory |
For further information, see a copy of the Academic Policy, available online (http://www.senecapolytechnic.ca/about/policies/academics-and-student-services.html) or at Seneca's Registrar's Offices. (https://www.senecapolytechnic.ca/registrar.html).
Modes of Evaluation
Assignments
- Assignments are due at the beginning of the class on which they are due.
- A late penalty of 10% per day is assessed for late assignments, including those not handed in at the beginning of class when due.
- Material will not be accepted after one week following the due date and/or when the marked material is returned to students, whichever comes first.
- Assignments are to be prepared by computer.
Absenteeism and Exams
- Students should be aware that absenteeism almost guarantees an inability to achieve satisfactory grades.
- Students who are absent for an examination due to an emergency (e.g., motor vehicle accident, hospitalization or death in the family) may provide official documentation within five days of the missed exam and be provided a deferred exam at a later date. Official documentation includes a death notice or an original doctor’s certificate identifying the date, length of time expected absence and the specific reason for the absence. Examinations missed without official documentation and approval result in a grade of zero.
- There are no deferred options for missed tests. The value of missed tests, at the discretion of the Faculty, will be added to other evaluation components
English Proficiency
- All written work should demonstrate the following characteristics for clarity and conciseness:
-spelling and punctuation are correct
-sentences are structured correctly
-main ideas are supported with specific, relevant examples and reasons
-work flows logically through supporting statements/paragraphs
-work is arranged in correct format (e.g., as a report, essay)
-up to 10% of the final grade may be deducted on all work if the above English competencies are not met.
Format for Assignments
- Students must use the standard, APA style for quoting sources. Help is available at: http://library.senecapolytechnic.ca
LAB COURSES
Laboratory Attendance
The laboratory component is essential and therefore it is strongly recommended that you attend all labs. Any missed labs must be supported with a legal document with three days of the lab. Any student who fails to attend 2 scheduled laboratory classes for a 7 week subject and more than 3 laboratory classes for a 14 week subject will not pass the subject.
Laboratory Safety
Students are required to review and understand the safety procedures and guidelines outlined on the first class and sign the sheet to this effect before beginning work in the laboratory. Students must also wear a lab coat and safety glasses when conducting experiments.
A student who arrives without the proper safety equipment will not be permitted to participant in the lab but will be asked to leave the class. The student will receive no grade for the lab missed.
Submitting Assignments
Assignments may NOT be submitted via e-mail or in any other electronic/disk format. Only paper copies will be accepted and marked. However, if there are special circumstances AND you have received prior approval from the instructor, you may be permitted to submit an electronic copy of your assignment. In this case, you will also be required to submit a paper copy by the date approved by the instructor.
Late Submissions Without Penalty
If you know ahead of time that you will be handing in an assignment late, e-mail notification must be sent to the instructor at least one week before the assignment due date. If you are sick or for other legitimate reasons cannot submit your assignment on the day it is due, e-mail notification must be sent to the instructor on the assignment due date. In both cases of late submissions, you will receive an e-mail response approving your late submission without penalty, and stating a new agreed upon due date.
Late Submissions With Penalty
Any take-home assignments handed in late (that do not meet the requirements outlined under Late Submissions Without Penalty will be deducted 10% per week.
Attendance
Consistent attendance is important for success in this subject. If you are absent from class, you are still responsible for the material and assignments.
Consultation Outside of Classroom Hours
By appointment.
Learning Centre
For free assistance in English, visit the Writing Centre and make an appointment with one of the tutors. Tutors can offer guidance and help you remedy writing problems, but will not proofread, or correct grammar, or alter content.
Grading is based on the following marking scheme:
|
|
10% |
|
Clarifax Response |
10% |
|
Pre-NDS Meeting Request |
10% |
|
Dispute Resolution Letter |
10% |
|
Product Promotion Review |
15% |
|
Response to Health Canada Inspection |
15% |
|
Product Monograph |
30% |
|
Resume Cover Letter |
5% |
STUDENT APPEALS
Students must keep all assignments (including drafts and outlines) and exercises until they have received their final grade. No appeal will be considered unless a complete file is submitted at the time of appeal. A lost assignment is no excuse.
If a student disagrees with the evaluation of an assignment or with a final grade, she/he must first discuss the matter with the instructor in an attempt to resolve the disagreement. If the matter is not resolved, the student should discuss the problem with the program coordinator.
For further information on appeals, please consult the Academic Policy Handbook.
PLAGIARISM
Plagiarism means cheating by pretending you wrote something that somebody else wrote. To do an assignment or write an essay you have to get your information from somewhere, but you have to state the source of the information. Finding your information fast is an important skill to develop; you are allowed to look anywhere. (Naturally, you have to do the looking: buying an essay is a major academic offence.) But you have to clearly state where you looked. You have to give credit to all the writers you got your words, your facts, or your ideas from. It is rude not to give them credit, and worse, it is another form of cheating. You are stealing, and then lying about it. It is an academic offence called plagiarism (from the Latin word plagiarius, meaning kidnapper).
Keep in mind two things about plagiarism: first, you are going to get caught. If you copy a paragraph out of a book and pretend it is your own work, you will receive a mark of zero. (And your assignment will not count; the course instructor will consider it a missed assignment.) Most instructors can spot plagiarism immediately, because they know your writing style, and, if they are unsure, they just type 10 words into Seneca's new anti plagiarism software that searches and tells them exactly where you stole it from.
Second, when caught plagiarizing, even if it is only a sentence or two, you will score 0 on that assignment, and if the Promotion Committee so judge, you will receive a notation on your transcript. (Second offence: immediate suspension from the college.) Seneca enforces its anti-plagiarism rules, whether the assignment is worth 2% or 60%. Avoiding plagiarism takes a little more work, but it beats--if it was a major assignment or a final exam--having to repeat the whole subject. All you have to do is document, i.e. tell the reader exactly where you got your information. If you find a good sentence or paragraph, copy it. You already know where you got it, so all you have to do is say so, by documenting properly.
SUGGESTED DOCUMENTATION OF SOURCES
Form of an in-text citation--footnotes and endnotes commonly used, in addition to a bibliography/works consulted section at the end of your work. The Chicago Manual of Style, APA is the (American Psychological Association), in the regulatory field.
For assistance related to citing sources properly, please visit our website: http://infoliteracy.senecac.on.ca/ah/
Other Evaluation Considerations
The student is expected to comply with the Safety Rules for working in the laboratory, sign the safety contract, and WILL NOT UNDER ANY CIRCUMSTANCES WEAR CONTACT LENSES in the laboratory. The student will know where all safety equipment is located in the laboratory and will be familiar with WHMIS concepts and signage.
PLEASE RETAIN THIS SUBJECT OUTLINE FOR POSSIBLE FUTURE USE IN SUPPORT OF CREDIT APPLICATIONS AT OTHER EDUCATIONAL INSTITUTIONS