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Biopharmaceutical International Regulatory Affairs, Postgraduate Certificate

  • Anytime
    Application Deadline
  • 12 months
    Duration
University rank #184 (WUR) Online
The Graduate Certificate in Biopharmaceutical International Regulatory Affairs curriculum focuses on reforms that facilitate the safety of global commerce.

About

The Graduate Certificate in Biopharmaceutical International Regulatory Affairs curriculum focuses on compliance standards that facilitate the global commercialization of safe and effective biotechnology and pharmaceutical medicinal products.

The need to understand international regulations affecting the business of biotechnology and pharmaceutical companies is imperative in the global marketplace. Students will be trained to assess international regulations and to provide an interpretation of their likely impact on the biopharmaceutical product manufacturers, healthcare practitioners and patients.

As a result of their completion of the program, students will gain an understanding of international regulatory requirements for countries where new biopharmaceutical products will be marketed. Coursework will cover product approval processes, regulatory analysis, and liability laws. With the rapid expansion of local companies into diverse global markets, current global regulatory affairs professionals, attorneys, paralegals, and biopharmaceutical science researchers will benefit from understanding evolving compliance and international regulations, as well as how to streamline global regulatory processes.

Programme Structure

Courses include:

  • lGobal Biotechnology Product Registration: EU, U.S., and Japan
  • European Union Compliance Process and Regulatory Affairs
  • Managing International Clinical Trials
  • Global Awareness: European Medical Device Regulations
  • Global Awareness: Canada, Asian, and Latin American Regulatory Affairs
  • Regulation of Biomedical Product Commercialization by Health Canada
  • Japanese Medical Device Regulations and Registrations
  • Canadian and Australian Medical Device Regulation
  • Global Awareness: Emerging Medical Device Markets
  • Strategic Planning and Project Management for Regulatory Affairs Professionals in Domestic and International Markets
  • Safety Sciences 1: Introduction to Safety and Surveillance for Drugs, Biologics, and Medical Devices in the U.S. and Abroad

Detailed Programme Facts

  • Programme intensity Full-time
    • Full-time duration 12 months
  • Credits
    16 credits alternative credits
  • Languages
    • English
  • Delivery mode
    Online

English Language Requirements

You only need to take one of these language tests:

  • Minimum required score:

    79

    The TOEFL iBT ® measures your English-language abilities in an academic setting. The test has four sections (reading, listening, speaking, and writing), each with a score range of 0-30, for a total score range of 0-120. Read more about TOEFL iBT ®.

    Schedule TOEFL®
  • Minimum required score:

    6.5

    The IELTS – or the International English Language Test System – tests your English-language abilities (writing, listening, speaking, and reading) on a scale of 1.00–9.00. The minimum IELTS score requirement refers to which Overall Band Score you received, which is your combined average score. Read more about IELTS.

    Schedule IELTS
  • Minimum required score:

    53

    PTE Academic (Pearson Test of English Academic) is a language test that enables students to demonstrate their writing, listening, speaking, and reading skills when applying to study in English. Delivered and marked by computer, it reports on a scale between 10 and 90.

Academic Requirements

  • Online application 
  • Statement of purpose (500-1000 words)
  • Professional resumé
  • Unofficial undergraduate transcripts
  • Two letters of recommendation
  • English Language Proficiency Proof

Getting a Student Visa

This is an online programme. You can attend from the comfort of your chair! So you don't need a student visa!

Tuition Fee

  • International Applies to you

    12206 USD/year
    Tuition Fee
    Based on the original amount of 12206 USD for the full programme and a duration of 12 months.
  • National Applies to you

    12206 USD/year
    Tuition Fee
    Based on the original amount of 12206 USD for the full programme and a duration of 12 months.
We've labeled the tuition fee that applies to you because we think you are from and prefer over other currencies.

Funding

Many students, both full- and part-time, will qualify for some form of financial aid or scholarships. We encourage all students who apply for admission to seek out these opportunities. We hope to assist you in reaching your goals to become a student at Northeastern University.

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The Bunker Hill Community College Scholarship is a scholarship opportunity for associate degree graduates from Bunker Hill Community College who are seeking to complete their bachelor’s degree at the College of Professional Studies (CPS) at Northeastern University.

Community College Technology & Engineering Scholarship

The Community College Technology & Engineering Scholarship was created to support bachelor’s degree-seeking students who intend to pursue an engineering and/or technology program that aligns with today’s industry needs.

Fast Track Your Education Scholarship

The Fast Track Your Education Scholarship is an opportunity for students who have been in the workforce for five or more years, have an associate degree or an equivalent of 60 semester hours (or 80 quarter hours) of transferrable credits, and are seeking to complete their bachelor’s degree in a fast-track format at the College of Professional Studies at Northeastern University.

Global Excellence Scholarship

The Global Excellence Scholarship was created to support students interested in global peer-to-peer learning by engaging with students from countries around the globe in the Bachelor of Science in Leadership – Global Classroom or the Bachelor of Science in Finance & Accounting Management – Global Classroom degree completion program.

Mass Bay Community College Scholarship

The Mass Bay Community College Scholarship is a scholarship opportunity for associate degree graduates from Mass Bay Community College who are seeking to complete their bachelor’s degrees at the College of Professional Studies (CPS) at Northeastern University.

Professional Information Technology Scholarship

The Professional Information Technology Scholarship was created to support bachelor’s degree-seeking students who intend to complete their degree in Information Technology and are currently working or seeking a career in the field.

Roxbury Community College Scholarship

The Roxbury Community College Scholarship is a scholarship opportunity for associate degree graduates from Roxbury Community College who are seeking to complete their bachelor’s degree at the College of Professional Studies (CPS) at Northeastern University.

Urban Education Community College Scholarship

The Urban Education Community College Scholarship was created to support bachelor’s degree-seeking students who intend to become teachers in urban schools.

Working Professionals Education Advancement Scholarship

The Working Professionals Education Advancement Scholarship is a scholarship opportunity for professionals who have been in the workforce for 10 or more years and are seeking to complete their bachelor’s degree at the College of Professional Studies at Northeastern University.

StudyPortals Tip: Students can search online for independent or external scholarships that can help fund their studies. Check the scholarships to see whether you are eligible to apply. Many scholarships are either merit-based or needs-based.

The Global Study Awards: get funded with up to £10,000 to study abroad

Together with the ISIC Association and British Council IELTS, StudyPortals offers you the chance to receive up to £10000 to expand your horizon and study abroad. We want to ultimately encourage you to study abroad in order to experience and explore new countries, cultures and languages.

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