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Pharmaceutical Regulatory Affairs and Quality Operations

Pharmaceutical Regulatory Affairs and Quality Operations

Program Code:RAQC
Campus:Seneca@York
Duration:2 semesters (1 Year)
Offered:Summer
Fall
Winter
Credential Awarded:Ontario College Graduate Certificate
Work-Integrated Learning:Optional Work Term

Program Description

In this program, you'll gain a foundational understanding of the areas of regulatory affairs and quality operations. Through studies of regulatory compliance in Canada and in other areas of the world, you'll be prepared for occupations involving drug or medical device submissions and quality assurance functions and roles.

The first semester will provide you with the fundamentals required in both regulatory affairs and quality operations. Introductory level courses equip you for the work term placement, which occurs between semesters and gives you the opportunity to apply the knowledge learned in the first semester. Your work term provides you with valuable industry exposure.

The second semester will provide more detailed and specific exposure to the areas of regulatory affairs and quality operations.

Admission Requirements

Program Eligibility:

  • A recognized degree from an accredited institution in science with a focus on chemistry, biology or pharmaceutical studies
  • English proficiency at the postsecondary level.

Additional Requirements:

  • Pre-admissions English test - Cost $55
  • Applicant profile

Applicant Selection:

  • Applicants will be invited to attend an orientation where they will complete the Pre-Admissions English test and applicant profile.
  • Applicants are ranked based on the strength of their Pre-Admissions English test and applicant profile.
  • Admission to this program is highly competitive. Only the top ranked applicants will be offered a seat in the program.

Fees

Loading Tuition Costs

Your Career

Focus your career by specializing in Pharmaceutical Regulatory Affairs and Quality Operations. With your one-year graduate certificate, you'll be prepared for a dynamic career as a regulatory affairs associate, regulatory affairs assistant, quality assurance associate, quality assurance investigator, documentation administrator or medical information associate in the pharmaceutical, biotechnological, veterinary, cosmetic and food industries.

Affiliations/Associations

  • Canadian Association of Professional Regulatory Affairs (CAPRA)
  • Drug Information Association (DIA)
  • Pharmaceutical Sciences Group (PSG)
  • Regulatory Affairs Professional Society (RAPS)

Work-Integrated Learning - Optional

Optional Work Term

Students meeting all academic requirements may have the opportunity to complete an optional work term(s) in a formal work environment. The work term(s) is similar in length to an academic semester and typically involves full-time work hours that may be paid or unpaid. In programs with limited work term opportunities, additional academic requirements and a passing grade on a communication assessment may be required for eligibility. Eligibility for participation does not guarantee a work position will be secured. Additional fees are required for those participating in the optional work term stream regardless of success in securing a work position.

Transfer Credit/Pathways

The Degree and Credit Transfer Office provides a number of services for students continuing their education at Seneca, and for graduating students considering degree transfer options.

Through transfer agreements and institution partnerships, graduates of this Seneca College program may be eligible for credit at various post-secondary institutions. Please refer to the Degree Transfer Guide for more information.

Transfer Credit may be granted for courses deemed equivalent to courses at Seneca that have been completed at recognized postsecondary institutions. Additional information is available online.

Important Academic Dates

Please take a few moments to view Important Academic Dates for your relevant term.

Courses

Please select the curriculum from the Academic Year in which you started (or will be starting) your studies. An Academic Year begins in September and ends in August of the following year.

2017/2018 Academic Year

Semester 1
PBB814 Biotechnology and Biopharmaceuticals
PFM714 Product Formulation and Manufacturing
PQA711 Introduction to Quality Assurance
PRA700 Introduction to Pharmaceutical Regulatory Affairs
TWC713 Technical Writing and Communication I
WTP100 Work Term Preparation (Work-Integrated Learning option only)
 
Work-Integrated Learning Term
RAQ441 Pharmaceutical Regulatory Affairs, Work Term (Work-Integrated Learning option only)
 
Semester 2
IRA815 International Regulatory Affairs and Harmonization
PCR901 Introduction to Clinical Research
PEC715 Pharmacoeconomics
PQA811 Quality Assurance II
PRA800 Regulatory Affairs II

2016/2017 Academic Year

Semester 1
PBB814 Biotechnology and Biopharmaceuticals
PFM714 Product Formulation and Manufacturing
PQA711 Introduction to Quality Assurance
PRA700 Introduction to Pharmaceutical Regulatory Affairs
TWC713 Technical Writing and Communication I
CPP100 or
WTP100
Co-op Professional Theory (Work-Integrated Learning option only) or
Work Term Preparation (Work-Integrated Learning option only)
 
Work-Integrated Learning Term
CWT100 or
RAQ441
Work Term (Work-Integrated Learning option only) or
Pharmaceutical Regulatory Affairs, Work Term (Work-Integrated Learning option only)
 
Semester 2
IRA815 International Regulatory Affairs and Harmonization
PCR901 Introduction to Clinical Research
PEC715 Pharmacoeconomics
PQA811 Quality Assurance II
PRA800 Regulatory Affairs II
CPP200 or
WIL100
Work-Integrated Learning Professional Practice (Work-Integrated Learning option only) or
Work-Integrated Learning (Work-Integrated Learning option only)

Contact Us

http://biochem.senecacollege.ca.
Admissions Advisors:
Domestic Admissions Advisor: Carsten Wuertz
(416) 491-5050 Ext. 22803
Carsten.Wuertz@senecacollege.ca
International Admissions Advisor: International Admissions
(416) 491-5050 Ext. 22364
InternationalAdmissions@senecacollege.ca
Registration & Records Advisor:
  Diane Duerden
(416) 491-5050 Ext. 33006
Diane.Duerden@senecacollege.ca
Program Contacts:
Student Advisor: Monica Russell
(416) 491-5050 Ext. 33769
Monica.Russell@senecacollege.ca
Program Coordinator: Tom McLerie
(416) 491-5050 Ext. 33245
Tom.McLerie@senecacollege.ca
Work-Integrated Learning Coordinator: Zahra Hirji
(416) 491-5050 Ext. 33218
Zahra.Hirji@senecacollege.ca
Program Chair: Paola Battiston
(416) 491-5050 Ext. 33760
Paola.Battiston@senecacollege.ca
Additional Contacts:
  Financial Aid & Awards
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