PFT930 - Industrial Drug Legislation

Outline info
Semester
School
Last revision date 2017-05-29 00:41:06.687
Last review date 2017-07-17 00:16:31.414


Subject Title
Industrial Drug Legislation

Subject Description
This subject examines the organizational role, responsibilities and requirements of Health Canada related to the production, labelling, selling, and advertising of drugs, radiopharmaceuticals, biologics, natural health products and medical devices in Canada. A review of USA and EU laws and regulations is also covered. (Lecture only) 

Credit Status
One credit toward the Industrial Pharmaceutical Technology Certificate Program

Learning Outcomes
Upon successful completion of this subject the student will be able to:

1. Describe the organization of Canada's Food and Drugs Act and Regulations.

2. Describe the organizational structure of Health Canada including the roles and responsibilities of various directorates, bureaus and regional offices.

3. Analyze the role of Health Canada in the regulation of the pharmaceutical industry.

4. Examine Health Canada guidelines as they relate to different aspects of manufacturing of drugs, radiopharmaceuticals, biologics, natural health products and medical devices.

5. Explore GMP and the processes of Clinical Trial Application, New Drug Development, Drug Submission and Drug Approval.

6. Discuss USA and EU laws and regulations related to the pharmaceutical industry.

Cheating and Plagiarism
Each student should be aware of the College's policy regarding Cheating and Plagiarism. Seneca's Academic Policy will be strictly enforced.

To support academic honesty at Seneca College, all work submitted by students may be reviewed for authenticity and originality, utilizing software tools and third party services. Please visit the Academic Honesty site on http://library.senecacollege.ca for further information regarding cheating and plagiarism policies and procedures.

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@senecacollege.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 Disabilities Services Office at ext. 22900 to initiate the process for documenting, assessing and implementing your individual accommodation needs.

Prerequisite(s)
It is strongly recommended that students have basic computer skills as this subject requires computer access.

Topic Outline

Unit 1       Introduction to Food and Drugs Act (historical perspective). Evolution of law. Integration of regulations – official guidelines and polices
Unit 2 Introduction to Health Canada: organizational structure within Health Canada. Changes in Food and Drugs Act and Food and Drug Regulations: process, implementation, enforcement.
Unit 3 Food and Drugs Act Parts I – IV and Schedules A-H.
Unti 4 Food and Drug Regulations Part A and Part C (Drugs) Division 1 and corresponding Health Canada guidance documents
Unit 5 Food and Drug Regulations Part C, Division 1A (Establishment Licences) and corresponding Health Canada guidance documents
Unit 6 Food and Drug Regulations Part C, Division 2 (GMP) and corresponding Health Canada guidance documents
Unit 7 Food and Drug Regulations Part C, Division 5 (Clinical Trials) and corresponding Health Canada guidance documents
Unit 8 Food and Drug Regulations Part C, Divisions 3, 4 (Schedule C and D Drugs) and corresponding Health Canada guidance documentsUnit 9 Food and Drug Regulations Part C, Divisions 6 and 9 (Canadian Standard Drugs, Non-prescription Drugs) and corresponding Health Canada guidance documents
Unit 10 Food and Drug Regulations Part C, Divisions 7 and 8 (New Drugs), prescription drugs (former schedule F drugs) and corresponding Health Canada guidance documents
Unit 11 Food and Drug Regulations Part G (Controlled Drugs) and Part J (Restricted Drugs).
Unit 12 Food and Drug Regulations Part D (Vitamins, Minerals and Amino Acids). Natural Health Products Regulations: history, structure, application and corresponding Health Canada guidance documents
Unit 13 Overview of laws and regulations in USA and EU
 

Mode of Instruction
Lecture and discussion

Prescribed Texts
Canada's Food & Drugs Act & Regulations & Amendments; accessed online http://laws-lois.justice.gc.ca/eng/acts/F-27/index.html
Canada's Food & Drugs Act: http://laws-lois.justice.gc.ca/eng/acts/F-27/
Canada's Food & Drug Regulations: http://laws-lois.justice.gc.ca/eng/regulations/C.R.C.,_c._870/
Canada's Natural Health Products Regulations: http://laws-lois.justice.gc.ca/eng/regulations/SOR-2003-196/

Reference Material
None

Required Supplies
None

Promotion Policy

Grading Policy
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.senecacollege.ca/academic-policy) or at Seneca's Registrar's Offices.


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:
-writing is consistent with the rules of English grammar
-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.senecacollege.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.

Grading is based on the following marking scheme:
Test #1 15%
Test #2 15%
Assignment 25%
Presentation 15%
Final Exam 30%
 
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

Approved by: Denis Gravelle