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  • Pharmaceutical Regulatory Affairs and Quality Operations

    Pharmaceutical Regulatory Affairs and Quality Operations

(Co-op)

Program Code:RAQC
Campus:Seneca@York
Duration:2 semesters (1 Year)
Start Dates:Summer, Fall, Winter,
Start dates are subject to change
Credential Awarded:Ontario College Graduate Certificate

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 co–operative 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 are 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)

Co-operative Education

The co–operative education component provides you with the opportunity to secure a paid work–term between academic semesters.

Job–related employment enables you to combine classroom skills and on–the–job training.

Transfer Pathways

Through transfer agreements and institution partnerships, graduates of this Seneca College program may be eligible for credit at the following post-secondary institution(s):

U.S.

University/CollegeDegrees Available
Davenport University• Any relevant Bachelor or Master of Business Administration

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.

2014/2015 Academic Year
Semester 1 Course Name Hrs/Wk
PBB814 Biotechnology and Biopharmaceuticals 4
PFM714 Product Formulation and Manufacturing 3
PQA711 Introduction to Quality Assurance 4
PRA700 Introduction to Pharmaceutical Regulatory Affairs 7
TWC713 Technical Writing and Communication I 3
CPP100 Co-op Professional Theory (co-op option only) 1
CWT100 Co-op Work-Term (co-op option only)
 
Semester 2 Course Name Hrs/Wk
IRA815 International Regulatory Affairs and Harmonization 3
PEC715 Pharmacoeconomics 3
PQA811 Quality Assurance II 4
PRA800 Regulatory Affairs II 6
PCR901 Introduction to Clinical Research 3
CPP200 Co-op Professional Practice (co-op option only) 1

2015/2016 Academic Year
Semester 1
Biotechnology and Biopharmaceuticals
Product Formulation and Manufacturing
Introduction to Quality Assurance
Introduction to Pharmaceutical Regulatory Affairs
Technical Writing and Communication I
Co-op Professional Theory (co-op option only)
 
Co–op Work–Term
Co-op Work-Term (co-op option only)
 
Semester 2
International Regulatory Affairs and Harmonization
Clinical Research
Pharmacoeconomics
Quality Assurance II
Regulatory Affairs II
Co-op Professional Practice (co-op option only)

Contact Us

For more information, please visit our website at: http://biochem.senecacollege.ca.
Admissions Advisors:
Domestic Admissions Advisor: Telephone: (416) 491-5050 Ext. 22840
Email: admissions@senecacollege.ca
International Admissions Advisor: Valentyna Gorodovych
Telephone: (416) 491-5050 Ext. 22432
Email: Valentyna.Gorodovych@senecacollege.ca
Registration & Records Advisor:
  Diane Duerden
Telephone: (416) 491-5050 Ext. 33006
Email: Diane.Duerden@senecacollege.ca
Program Contacts:
Student Advisor: Monica Russell
Telephone: (416) 491-5050 Ext. 33769
Email: Monica.Russell@senecacollege.ca
Program Coordinator: Tom McLerie
Telephone: (416) 491-5050 Ext. 33245
Email: Tom.McLerie@senecacollege.ca
Co-op Coordinator: Zahra Hirji
Telephone: (416) 491-5050 Ext. 33218
Email: Zahra.Hirji@senecacollege.ca
Program Chair: Paola Battiston
Telephone: (416) 491-5050 Ext. 33760
Email: Paola.Battiston@senecacollege.ca
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