Regulatory Affairs

Assignment #4: HPC (20%)
This assignment relates to the following Course Learning Requirement:
CLR 3 – Design briefing documents that communicate clear company messages to the media and/or
general public.
Objective of this Assignment: To design a healthcare professional communications (HPC).
Using Lesson 10 as a reference, design a healthcare professional communication (HPC) for a product. Be
creative and inventive regarding product and case details required.
Use the following resources to aid in this assignment:
 Health Canada’s Standardized Health Product Risk Communication Template and Guidance
document (see lesson 10 for links)
 Product info for 1 product from:
1. Health Canada’s Published Index / Health Product InfoWatch / Canada Adverse Reaction
Newsletters (CARN)
and / or
2. Recalls & Alerts Database
When preparing annual summary reports, PSURs or PBRERs, the line listings in these reports account for
cases that are not only reported to the drug manufacturer but also to cases reported by health care
professionals and patients which are accessible via the Canada Vigilance Adverse Reaction Database.
A professional-looking document, free of spelling and grammar errors is expected. This assignment is to
be an individual effort and must be submitted online by the time indicated.
When you structure your assignment, please do the following:
 first page is to be a cover page and you should indicate assignment #, title, course name, course
code, course facilitator, student name and ID, and date
 the last page should list any applicable references;
 name the file with your last name, the # of the paper, and course code (i.e., if it were your first
paper, the file would be Smith_01_SCI4100.doc);
 number the pages in the header;
 keep text single space and a easily readable font (Calibri 11pt); and
 include your name in the footer of each page.
The referencing format must follow the Publication Manual of the American Psychological Association
(APA). APA format has been used throughout the reading in this lesson and a tutorial can be reviewed at
the following link:
Assignment Grading Rubric (20%)
Criteria Excellent
Requires Improvement
Assignment Quality All information offered is accurate
All views are clearly expressed and
well explained
Contains original ideas,
connections or applications
Most information offered is
Most views are clearly
expressed and explained
Contains mainly original ideas,
connections or applications
Some or no accurate information
Views are rarely or never clear
and require further explanation
Many non- original ideas, or
unclear connections or
Knowledge and Skills
Clear, concise synthesis of course
content to demonstrate
understanding of topic
All ideas are clearly developed,
organized logically, and connected
with effective transitions
Explores ideas, supports points fully
using a balance of evidence, Uses
effective reasoning to make useful
All relevant course and topic links
are made
Evidence of some synthesis of
course content to
demonstrate understanding
of topic
Some unified and coherent
ideas are developed with
effective transitions
Supports most ideas with
effective examples, and/or
references, and details, makes
key distinctions
Most relevant course and
topic links are made
Lack of evidence or weakness in
the synthesis of course content
to demonstrate understanding of
Develops and organizes ideas
that are not necessarily
connected. Some ideas seem
illogical and/or unrelated
Presents ideas in general terms,
Most ideas are
inconsistent/unsupported, and
reasoning is flawed or unclear
Some or no relevant course and
topic links are made
Formatted as per assignment
Formatted as per assignment
details in most components
Formatting has not been
Structure and format enhances
delivery of the information
Clear language is used which leads
to easy readability
Correct grammar and spelling is
consistently used
Structure and format fits well
with the delivery of the
Mostly clear language is used
with minor readability issues
Few or no spelling and/or
grammatical errors
Structure and format is unclear
and impedes delivery of the
Language used is often unclear
which impedes readability
Many spelling and grammatical


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