Area Of Interest: Environmental And Applied Sciences Regulatory Affairs .
Area of Interest: Environmental and Applied SciencesRegulatory Affairs - Sciences (Co-op and Non Co-opVersion)Ontario College Graduate Certificate1 YearOttawa CampusAcademic Year: 2022/2023Program Code: 1523X03FWOOur ProgramPursue a career in protecting the safety of people and the environment.The Regulatory Affairs - Sciences Ontario College Graduate Certificate program provides youwith the skills and knowledge to pursue an entry-level career in industry and governmentregulatory agencies in Canada.The regulation of products in industries such as healthcare, biotechnology, food, industrialchemical and agrochemical is of international concern. The resulting increase in regulation hasdriven the demand for qualified individuals in regulatory affairs.With a focus on protecting the safety of people and the environment, professionals in this fieldhave a positive impact on the public good.Understand the regulatory environment in Canada, including the socioeconomic aspects of: regulations across industries how to interpret and apply regulations, and how to develop and manage regulatory submissionsLearn project management and communications skills, and assess regulatory compliance andthe frameworks that govern processes and products.Students also have the option to gain real-world experience through a paid co-operativeeducation (co-op) work term (see Additional Information for more details). Please note thatplaces in the co-op version of the program are subject to availability. Students who elect toapply to the non co-op version of the program may not have the opportunity to transfer to theco-op version at a later date.Graduates of this program have a strong understanding of regulation generally but develop adetailed understanding of regulation for protecting public, worker and environmental healthand safety in the areas of: pharmaceuticals and medical devices agrochemicals industrial chemicals, including in manufacturing and consumer productsYou may also find employment in positions such as: quality assurance specialist administrator in various regulated industries analyst associate1
Regulatory Affairs - Sciences (Co-opand Non Co-op Version) consultant regulatory compliance officerSUCCESS FACTORSThis program is well-suited for students who: Possess strong written and oral communication skills. Are adept at analytical and critical thinking and are detail-oriented. Are inquisitive and able to analyze, evaluate and apply relevant information from a varietyof sources. Effectively conduct research and analyze findings. Possess effective leadership skills. Have a strong interest in protecting the safety of people and the environment.EmploymentGraduates are well positioned for a variety of entry-level employment opportunities in theregulatory affairs sector. Positions may include but are not restricted to regulatory affairsofficers, associates, analysts and consultants, regulatory compliance officers and consultants,and quality assurance specialists and administrators in the various regulated industries.Depending on the type of prior industry experience and credentials held, graduates may riseinto positions with increasing levels of responsibility.Employment may be found in organizations of all sizes in both the public and private sectors.Learning OutcomesThe graduate has reliably demonstrated the ability to: Optimize processes, practices and products by interpreting and assessing the role ofregulatory affairs in the healthcare, food, agrochemical and industrial chemical industries. Relate the roles and responsibilities of regulatory professionals in industry andgovernment to explain their purposes to stakeholders. Distinguish between Canadian and international regulatory environments to anticipate theresults of international harmonization. Ensure compliance with established regulations and laws that govern processes andproducts as per Canadian policies and professional standards. Prepare and evaluate components of regulatory submissions and supplementaldocumentation for products within the pharmaceutical, medical devices, biotechnology,agrochemical or industrial chemical sectors. Evaluate a wide range of data analyses to support decisions in the regulatory process. Anticipate the potential impact of regulatory changes to provide risk-mitigatingrecommendations. Conduct socio-economic impact analyses regarding the introduction of new products orpolicies on relevant industries and society. Apply collaborative project management principles, leadership techniques and effectivecommunication to ensure the timely and successful completion of projects. Identify and apply discipline-specific practices that contribute to the local and globalcommunity through social responsibility, economic commitment and environmentalstewardship.2
Regulatory Affairs - Sciences (Co-opand Non Co-op Version)Program of StudyLevel: 01CoursesHoursGEP1001Cooperative Education Readiness18.0MGT4501Project Management56.0RGL2000Governance and Policy Instruments42.0RGL2100Regulation Theory42.0RGL2200Regulation Design56.0SCI4003Scientific Communication for Public Policy42.0SCI4100Science and Risk Assessment in Regulation42.0Level: 02CoursesHoursQUA3000Critical Data Analysis in Regulation56.0RGL3000Socioeconomics of Regulation Design56.0RGL3100Regulatory Processes56.0RGL3200Pre-Market Regulatory Submission84.0RGL3300Submission Evaluation and Post-Market Analysis42.0Co-op: 01CoursesHoursWKT2300Work Term IFees for the 2022/2023 Academic YearTuition and related ancillary fees for this program can be viewed by using the Tuition and FeesEstimator tool at https://www.algonquincollege.com/fee-estimator .Further information on fees can be found by visiting the Registrar s Office website athttps://www.algonquincollege.com/ro .Fees are subject to change.Additional program related expenses include:Books and supplies cost approximately 300.Admission Requirements for the 2023/2024 Academic YearProgram Eligibility Ontario College Advanced Diploma, Degree or equivalent. Applicants with international transcripts must provide proof of the subject-specificrequirements noted above and may be required to provide proof of language proficiency.Domestic applicants with international transcripts must be evaluated through theInternational Credential Assessment Service of Canada (ICAS) or World Education Services(WES). IELTS -International English Language Testing Service-Overall band of 6.5 with a3
Regulatory Affairs - Sciences (Co-opand Non Co-op Version) IELTS -International English Language Testing Service-Overall band of 6.5 with aminimum of Reading: 6.0; Listening: 6.0; Speaking: 6.0; Writing: 6.5, TOEFL-Internet-based(iBT)-overall 90, with the minimum in each component: Reading: 22; Listening: 22;Speaking: 22; Writing: 24.Admission Requirements for 2022/2023 Academic YearProgram Eligibility Ontario College Advanced Diploma, Degree or equivalent. Applicants with international transcripts must provide proof of the subject-specificrequirements noted above and may be required to provide proof of language proficiency.Domestic applicants with international transcripts must be evaluated through theInternational Credential Assessment Service of Canada (ICAS) or World Education Services(WES). IELTS -International English Language Testing Service-Overall band of 6.5 with aminimum of Reading: 6.0; Listening: 6.0; Speaking: 6.0; Writing: 6.5; OR TOEFL-Internetbased (iBT)-overall 90, with the minimum in each component: Reading: 22; Listening: 22;Speaking: 22; Writing: 24.Application InformationREGULATORY AFFAIRS - SCIENCES (CO-OP AND NON CO-OP VERSION)Program Code 1523X03FWOApplications to full-time day programs must be submitted with official transcripts showingcompletion of the academic admission requirements through:ontariocolleges.ca60 Corporate CourtGuelph, Ontario N1G 5J31-888-892-2228Applications are available online at http://www.ontariocolleges.ca/ . A fee applies.Applications for Fall Term admission received by February 1 will be given equal consideration.Applications received after February 1 will be processed on a first-come, first-served basis aslong as places are available.International applicants applying from out-of-country can obtain the International StudentApplication Form at https://xweb.algonquincollege.com/FormIE/index .aspx or by contactingthe Registrar s Office.For further information on the admissions process, contact:Registrar s OfficeAlgonquin College1385 Woodroffe AveOttawa, ON K2G 1V8Telephone: 613-727-0002Toll-free: 1-800-565-4723TTY: 613-727-7766Fax: 613-727-7632Contact: https://www.algonquincollege.com/roAdditional InformationApply directly to the co-op or non co-op version of this program throughhttp://www.ontariocolleges.ca/ or our International Application Portal.Cooperative education (Co-op) allows students to integrate their classroom learning with a realworld experience though paid work terms. Two academic terms prior to the cooperativeeducation work term, students are required to actively participate in and successfully completethe self-directed co-op online readiness activities and in-person workshops.4
Regulatory Affairs - Sciences (Co-opand Non Co-op Version)Students must actively conduct a guided, self-directed job search and are responsible forsecuring approved program-related paid co-op employment. Students compete for co-oppositions alongside students from Algonquin and other Canadian and international colleges anduniversities. Algonquin College s Co-op Department provides assistance in developing co-opjob opportunities and facilitates the overall process, but does not guarantee that a student willobtain employment in a co-op work term. Co-op students may be required to re-locate to takepart in the co-op employment opportunities available in their industry and must cover allassociated expenses; e.g., travel, work permits, visa applications, accommodation and all otherincurred expenses.Co-op work terms are typically 14 weeks in duration and are completed during a term whenstudents are not taking courses.International students enrolled in a co-op program are required by Immigration, Refugees andCitizenship Canada (IRCC) to have a valid Co-op/Internship Work Permit prior to commencingtheir work term. Without this document, International students are not legally eligible toengage in work in Canada that is a mandatory part of an academic program.For more information, please visit https://www.algonquincollege.com/coop .This program is also available online via the Centre for Continuing and Online Learning atalgonquincollege.com/ccol. While admission requirements specify that an Ontario CollegeAdvanced Diploma is required for entry into the program, please be advised that mostgovernment and some industry positions require a degree. In particular, a B.Sc. is required bygovernment agencies, such as Health Canada. Interested applicants should explore theminimum credential requirements for the career in their desired sector.All courses are offered in the evenings, after 4pm.Graduates with degrees are encouraged to apply for Federal Student Work Experience Program(FSWEP) opportunities.Contact InformationProgram Coordinator(s) Thomas Conway, mailto:conwayt@algonquincollege.com , 613-727-4723, ext. 6002Course DescriptionsGEP1001 Cooperative Education ReadinessStudents are guided through a series of activities which prepares them for their co-op jobsearch term. Through a detailed orientation students learn the cooperative education programpolicies and procedures related to searching and securing a work term opportunity. Studentsidentify their strengths and transferable skills and participate in workshop style sessions thatfocus on cover letter and resume development, interview techniques and job search strategies.Students learn how to navigate HireAC where employers post cooperative education jobopportunities. Students reflect on workplace success, ethics and responsibilities.Prerequisite(s): noneCorerequisite(s):noneMGT4501 Project ManagementProject management and leadership skills are critical for professionals in both the public andprivate sectors. Students investigate principles, tools and techniques of project managementand learn to mitigate common issues to ensure project success and stakeholder satisfaction.Through case studies and team work, students explore leadership and team dynamics.Prerequisite(s): noneCorerequisite(s):noneQUA3000 Critical Data Analysis in Regulation5
Regulatory Affairs - Sciences (Co-opand Non Co-op Version)Regulatory decisions require not only an understanding of statistical data and processes, butalso the ability to think critically about their application. Students investigate how statisticalinformation is used to make regulatory decisions, explore the type of statistical analyses thatare most appropriate in the various regulatory sectors, and describe how regulatorymethodology can affect risk mitigation, and compliance. Students apply basic statisticalconcepts to data and explain their utility in regulatory decision-making. Using publishedliterature, students examine data to understand the design, accuracy, and effectiveness ofstudies for use in regulatory processes.Prerequisite(s): SCI4100Corerequisite(s):noneRGL2000 Governance and Policy InstrumentsAn understanding of the regulatory framework in Canada and familiarity with internationalregulatory regimes is of paramount importance to professionals in regulatory affairs. Studentsexamine and discuss legislation, policies and acts that shape regulations in Canada, and explorethe relationships between regulations and policy instruments available to government. Usingcase studies, students situate regulations in the wider framework of governance across varioussectors. Students work independently and in small groups to research, summarize and presentcomparisons of different regulatory regimes internationally and discuss the history, scope andpotential impacts of the harmonization of those regimes.Prerequisite(s): noneCorerequisite(s):noneRGL2100 Regulation TheoryRegulatory professionals must understand the role of regulation in serving the public interest.Students explore the purpose and impact of both pre- and post-market regulations, examinerisk management strategies and discuss the roles of regulatory professionals. Through casestudies and discussion, students develop a sound understanding in regulation theory and boththe ethical and socioeconomic implications of regulatory practice.Prerequisite(s): noneCorerequisite(s):noneRGL2200 Regulation DesignThe design of a regulation has extensive implications for both government and industrystakeholders. Students explore performance-based and prescriptive regulations and discuss theimpact on the roles and responsibilities of stakeholders, as well as concerns for compliance andenforcement. Students examine how patents, trademarks and copyrights relate to regulatoryissues. Using case studies, students classify regulations, relate regulations to pertinentlegislation and investigate the implications of a new or evolved technology, performance orprocess standard.Prerequisite(s): noneCorerequisite(s):noneRGL3000 Socioeconomics of Regulation DesignChanges to regulations often have far-reaching consequences for all stakeholders. Studentsexamine the role of relevant risk-management and socioeconomic principles in the regulatoryprocess. Using case studies, students analyze the impacts of regulatory changes, the use ofcost-benefit analysis and propose impact-mitigating strategies. Working independently and ingroups, students examine Regulatory Impact Analysis Statements (RIAS) and StrategicEnvironmental Assessments (SEA).Prerequisite(s): RGL2100 and RGL2200Corerequisite(s):noneRGL3100 Regulatory Processes6
Regulatory Affairs - Sciences (Co-opand Non Co-op Version)The regulatory processes in the pharmaceutical, agrochemical and industrial chemical industriesvary widely. Students explore the regulatory processes and the roles of regulatory professionalsin these three key industries and investigate how the regulations impact product development.Students consider the life cycle components of regulations in each industry, includingstakeholders, risk assessments and pre- and post-market perspectives. Students analyze theagrochemical sector in detail.Prerequisite(s): RGL2200Corerequisite(s):noneRGL3200 Pre-Market Regulatory SubmissionRegulatory submissions are critical components of the regulatory process for both governmentand industry. Students work with industry to complete a regulatory submission from one of thefollowing areas: pharmaceuticals, medical devices, biotechnology, natural health products,agrochemicals and/or industrial chemicals. Students delineate the appropriate sequence andprocesses required for new product approval, including the selection of appropriate guidancedocuments.Prerequisite(s): MGT4501 and SCI4003Corerequisite(s):noneRGL3300 Submission Evaluation and Post-Market AnalysisThe regulatory requirements for a new product continue beyond the regulatory submission, toits evaluation and continued regulatory control once the product is on the market. Studentsconsider the submission approval process and investigate the regulatory concerns for productsonce they are on the market. Using case studies, students apply the regulatory requirements atvarious stages in the evaluation of a new drug submission and determine the factors thatcontribute to approval or rejection.Prerequisite(s): MGT4501Corerequisite(s):noneSCI4003 Scientific Communication for Public PolicyClear, concise and effective communication is required for success in this industry. Studentsexplore and apply industry-specific technical writing strategies, such as assessing scientificprocedures and clearly articulating complex technological problems. Through writtenassignments, presentations and simulating briefing activities, students develop written andspoken communication skills essential for professionals in this sector.Prerequisite(s): noneCorerequisite(s):noneSCI4100 Science and Risk Assessment in RegulationRisk assessment using scientific data is critical for making sound regulatory decisions. However,the science used to assess risk varies widely across industries. Students investigate howscientific data is used in different fields and compare the risk assessment strategies used indifferent industries. Using case studies, students explore the validity of claims supported bydifferent types of scientific data and discuss how risk assessment leads to effective riskmanagement. In addition, students enhance research skills and the ability to assess thecredibility of sources.Prerequisite(s): noneCorerequisite(s):noneWKT2300 Work Term IStudents complete a paid full-time work term with an employer off campus. The placement ismonitored by the College and assignments, including a final report, must be completed. TheCollege provides assistance in finding a placement.7
Regulatory Affairs - Sciences (Co-opand Non Co-op Version)Prerequisite(s): noneCorerequisite(s):none8
regulatory affairs sector. Positions may include but are not restricted to regulatory affairs officers, associates, analysts and consultants, regulatory compliance officers and consultants, and quality assurance specialists and administrators in the various regulated industries.
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