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Graduate Certificate in Pharmaceutical Regulation

Through this Graduate Certificate Programme, we aim to equip working professionals like yourself with updated scientific and regulatory knowledge and critical skills through application-based learning. The skillsets gained through this programme will help you assume diverse roles requiring regulatory science expertise within the public and private sectors. 

 

An enhanced understanding of regulatory issues will better prepare you to facilitate innovation and pharmaceuticals development as well as provide a deeper appreciation of the basis of regulatory requirements, contributing to timely research and marketing authorisation decisions to support the healthcare systems. 

Guided by the Duke-NUS and CoRE education philosophy, the programme aims not only to impart knowledge and understanding but also to facilitate significant networking amongst regulators, industry and other stakeholders. You will have the opportunity to meet international and regional experts with different backgrounds and these interactions will expand your worldview by providing global and regional insights and enhancing your understanding of different perspectives.  

 

The curriculum will promote interdisciplinary inquiry and cover different skill sets and technical areas. Graduates will be more adept at effectively working and communicating within a team with an international outlook, given the diverse and international backgrounds of our course participants. 

 

The programme is targeted at early and mid-career regulatory professionals from the public and private sectors who wish to enhance their regulatory competencies. It is also suitable for professionals from the healthcare sector, including biomedical researchers, product developers and policymakers who are interested in gaining insights on the impact and contributions of regulatory science to the wider healthcare environment.

 

  

The Graduate Certificate curriculum is designed to expand your core skills and expose you to new competencies. We are committed to providing a holistic robust curriculum which is structured to: 

 
Click here to download the Graduate Certificate in Pharmaceutical Regulation Brochure. 
For information about funding support, email us at CoRE_education@duke-nus.edu.sg 

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CoRE’s academic setting, prominent reputation and strong international networks enable us to engage key opinion leaders as our external experts, faculty and speakers. They come from national regulatory authorities, noted companies, government agencies and industry associations.

 
These experts are recognised for their extensive real-world experience and contributions to regulatory and healthcare excellence. As a student, you will have the opportunity to engage with them in workshops, seminars, symposiums and conferences.

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Admission Requirements

The Admissions Committee reviews all application material, reference letters, and interviewer comments carefully to better understand each applicant.

Applicants must have an undergraduate Bachelor’s degree or its equivalent in relevant discipline. Relevant work experience (i.e., in the fields of regulatory, healthcare or research) at the time of matriculation into Duke-NUS Medical School is desirable. Applicants from non-English speaking countries will be required to present documentary evidence of their competence in written and spoken English (TOEFL or ILS).

Fees

The programme comprises of 4 modules.

The tuition fees are as follows: $14,445.00 per programme, or $3,611.25 per module.

Student Service Fee (SSF): Students are required to pay an additional $261.85 per semester.  In the event that students do not take any modules that semester, they would not have to pay this fee.


Notes:

1. All fees shown are inclusive of prevailing GST. 

2. Tuition fees for the Graduate Certificate are reviewed by the Singapore Ministry of Education and subject to change annually.


Refund Policy

Students who leave the University, either through withdrawal of their own accord or termination of candidature by the University, will not be granted a refund of tuition fees or Student Service Fees. Requests for refund of tuition fees or Student Service Fees will not be considered.


Skillsfuture

Skillsfuture is available for registered students.

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Your student bill will reflect the nett amount payable after subsidy.

For full eligibility criteria and application details, visit:

  • Self-financing
  • Company sponsored
  • How to Apply

    Application to the Graduate Certificate closes on 3 August 2018.

    1. Register at https://www.duke- nus.edu.sg/core/page/graduate-certificate-pharmaceutical-regulation-registration-form (a non-refundable application fee of $50 applies)

    2. Register for a username and password on our CoRE website to proceed. Complete the online application form, which includes various sections on personal data, academic records, past activities and achievements, research experience and essays. Click here for a step by step guide.

    To apply, candidates must submit the following:

    • A completed online application, available at https://www.duke- nus.edu.sg/core/page/graduate-certificate-pharmaceutical-regulation-registration-form  (a non- refundable application fee of $50 applies)  
    • Official transcripts from Bachelor’s  degree programme(s) (and higher, if applicable)
    • Official certificate awarded from Bachelor’s degree programme
    • Soft copy of NRIC/passport
    • World Education Services report will be requested if required
    • Applicants from non-English speaking countries will be required to present documentary evidence of their competence in written and spoken English (TOEFL or ILS). 
    • Recommendation letters, if available, to support the application (typically from professors, mentors and/or employers)

    3. Make payment to successfully submit your application.

    An offer letter will be sent via email to all successful applicants within 4 weeks from the date of application.

    Applicants will be given one week to accept the offer.

    Students will be able to enrol for module(s) here. 

    Students will receive information to log into the NUS Student Information System and verify their details.

    Students will be able to log into the NUS Student Information System and make payment via NETS, cheque/ bank draft, cash, telegraphic transfer, internet banking (using “Bill Payment / Payment” option) or credit/debit cards (online only).

    All successful candidates will be invited to attend Orientation before the commencement of classes.
    Original documents subject to verification during Orientation.

    Students will receive information to access the Duke-NUS Learning Management System where the online course materials can be found.

    As an advocate for continuous learning, we are excited to partner with you on your career development journey. To ensure that you are exposed to the full scope of knowledge, skills, and competencies for your career development, the course content is structured to broaden your perspectives and provide a holistic view of the regulatory ecosystem. It aims to deepen your understanding of the science underlying health product regulation and regulatory frameworks. It will also provide you with a practical and realistic view of what regulatory science involves through interactions with experts and practitioners from industry and national regulatory authorities.

    Through the course modules, you will strengthen your foundations in regulatory science while understanding the basis for managing regulatory submissions and processes, and making quality regulatory decisions. Review and discussion of cutting-edge scientific and regulatory topics will empower you to facilitate the development of regulatory strategy and policy, and strengthen your regulatory leadership capabilities.

    To meet the objectives of the programme and achieve the learning outcomes, the Duke-NUS pedagogy framework has been incorporated. This pedagogy is an integration of lectures and Team-Based Learning, creating a novel approach that fosters the development of life-long learners, problem solvers and critical thinkers. Emphasising the Duke-NUS Educational Philosophy, this framework promotes continuing education while offering the flexibility and accessibility required by working regulatory professionals.

    The curriculum is tailored to be relevant, contemporary, and accessible through an emphasis on three themes that run across all the modules to:

    Building on these common themes, the programme will provide you with the relevant skillsets and mindset to deepen your understanding and lead you through the modules. With an emphasis on ‘how to’, you will leave with actionable plans on ‘how to’

    • Use knowledge of various regulatory systems and principles of product lifecycle management to support quality decision-making in the organisation
    • Leverage current regulatory platforms and resources to adopt and implement good regulatory practices
    • Relate technical datasets to regulatory requirements and support good practices
    • Advocate the role and contributions of regulatory professionals to the wider healthcare systems

    The flexible curriculum is designed to accommodate your busy work schedule, allowing you to plan your course of career development to meet your needs and interests. The programme is taught through a blended learning approach, engaging students through an online learning management system that delivers content, enables student assessments, and allows for interaction between students. Each module will also feature a 5-day face-to- face workshop, specifically designed to accommodate the demanding work schedule of your full-time job.

    The programme structure below outlines the 4 subject areas you will focus on. To graduate, you will be required to complete a total of 4 modules out of the 8 modules offered, which can be completed within a year.

    Activities during the course will be graded to fulfil academic requirements. Each course module will include formal and informal assessments guided by the Duke-NUS teaching pedagogy. You will be graded on individual and group tests as well as group presentations during class discussions.

     

    Candidature 
    As the module credits are valid for a period of five years, it will provide the necessary flexibility for planning your schedule to complete this course, based on your work commitment.

    Continuation and graduation requirements 
    If unable to complete or pass a module, you are allowed to re-take the module once. You may also choose to take a different module if applicable within the Graduate Certificate course.

    Frequently Asked Questions

    a) What is the selection process? When will I be informed about the outcome of my application?
    An application committee will review all applications. You will be informed of the outcome of your application within 4 weeks from your date of submission.

      

    b) Can working experience be used for entry consideration if I do not have a basic degree?
    NUS requires the minimum of a Bachelor’s degree for entry into a Graduate Certificate Programme.
      

    c) I am only interested in one topic in the Graduate Certificate Programme. Can I take only 1 module?
    Yes, you will be able to sign up for single module offering. Application timelines will be the same as Graduate Certificate Programme students i.e. in May and October each year. Registration and NUS Student Service fees will apply.

      

    d) How many intakes are there per year?
    There are 2 intakes per year with 1 intake each semester. Registration begins in May for Semester 1 (beginning in August) and in October for Semester 2 (beginning in January) of each year.

    a) Am I allowed to change my choice of selected modules?
    There will be a selection period prior to the commencement of each semester with the finalised dates of the modules provided and as such, we do not foresee circumstances when a change of module is necessary.

      

    b) Can I attend all the advanced topics instead and still qualify towards the Graduate Certificate?
    The current requirements are the only approved route by NUS.

    a) Why is there a need for the 5-day intensive face-to-face workshop?
    This is in alignment to the principal pedagogy used in Duke-NUS, successfully applied for graduate medical students and adapted to adult professional learning. Students acquire the baseline knowledge using the online pre-read materials at their own pace. The workshop will include a few lectures that further expound on selected principles with real-life examples and insights from the experts. However, the main learning experience comes from the practical sessions, where students can expect to work on case examples and scenarios that reflect the actual environment. The use of team-based learning during these sessions will facilitate experiential learning through engaging different perspectives, reflecting solutions as a group, and interacting with the experts. The workshop presents a valuable opportunity to learn from peers and experts in an optimized learning environment.

      

    b) How are we assessed during the module and for fulfilling the requirements of the Graduate Certificate Programme?
    Assessments will be carried out throughout all the activities of the module. Graded quizzes will be incorporated into the pre-read materials uploaded onto the online Learning Management System. Scores for individual and group tests during the 5-day workshop will also be counted towards the final grade. The majority of the grading exercise will be based on the quality of the group presentations during the workshop, assessing the ability to apply the knowledge and exhibit deeper understanding of the taught concepts.

      

    c) I cannot guarantee my availability for all the modules in the 2 years. How long can I delay completing the course?
    Modular credits accumulated during the course are valid for 5 years from the date of enrolment into the programme.