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Certificate for Module (Regulatory Systems of Pharmaceutical Products and Medical Devices in the Greater Bay Area)

Microcredential Course

Course Code
HS227A
Application Code
2260-HS227A
Certificate for Module (Regulatory Systems of Pharmaceutical Products and Medical Devices in the Greater Bay Area)
QF Level: 6 QR Registration No.: 24/000794/L6 QR Registration Validity Period: 01 Oct 2024 - on-going
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Credit
9
Study mode
Part-time
Start Date
To be advised
Duration
30 hours
Language
English
Course Fee
HK$9500
Enquiries
37620096
25718480
lily.twl.chan@hkuspace.hku.hk
How to Apply
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How to Apply

Highlights

The programme aims to provide the latest knowledge in some major disciplines related to regulatory systems of pharmaceutical products and medical devices in the Greater Bay Area (GBA) such as product registration, legislation, contract manufacturing and testing, preclinical and clinical studies, regulatory affairs etc. It is designed for students who are interested in the regulatory systems under the jurisdictions of (1) the National Medical Product Administration (NMPA) in the Mainland (2) the Department of Health (DH) in Hong Kong SAR and (3) the Serviços de Saúde de Macau (SSM) in Macau SAR.

 

On completion of the programme, students should be able to

  1. outline the registration process and requirements of pharmaceuticals and medical devices under the jurisdictions of the NMPA, DH and SSM.
  2. establish key points of agreement and validation criteria with contract manufacturing organisations (CMOs) in the Mainland.
  3. critique the technical parameters when designing pre-clinical and clinical studies with contract research organisations (CROs) in compliance with the regulatory requirements in the Mainland.
  4. discuss the impact of legal requirements on import/export, sales and marketing of pharmaceuticals and medical devices in the Mainland.
  5. apply current practices of pharmacovigilance, product recall, and post-marketing activities in the Mainland.

Programme Details

Syllabus

  • Regulation of Pharmaceutical Products in Hong Kong and Macau
  • Regulation of Medical Devices in Hong Kong
  • Regulation of Medical Devices in the United States (US) and European Union (EU)
  • Registration of Pharmaceutical Products and Medical Devices in NMPA
  • Contract Manufacturing and Testing of Pharmaceutical Products and Medical Devices
  • Pre-clinical and Clinical Testing in the Mainland
  • Intellectual Property Protection in the Mainland
  • Import/Export and Marketing of Pharmaceutical Products and Medical Devices in the GBA
  • Undesirable Medical Advertisements Ordinance in Hong Kong and similar regulations in Macau and the Mainland
  • Pharmacovigilance in the Mainland

Assessment

Students are required to complete and pass all the assessments, including group presentation and written examination. 

Award

Students who successfully pass all the assessments and achieve 70% attendance will be awarded a "Certificate for Module (Regulatory Systems of Pharmaceutical Products and Medical Devices in the Greater Bay Area)" within the HKU system through HKU SPACE.

Application Code 2260-HS227A -

Fee

Application Fee

HK$150 (Non-refundable)

Course Fee
  • Course Fee : HK$9500

Entry Requirements

Applicants should

  1. hold a bachelor’s degree awarded by a recognised university in a science or healthcare related discipline, e.g. biology, biotechnology, biochemistry, pharmacy, medicine, nursing, public health; OR
  2. hold a bachelor’s degree awarded by a recognised university in a business, marketing, or management related discipline and one year of relevant work experience; OR
  3. hold a higher diploma in a science or healthcare related discipline, e.g. applied biology, biotechnology, biomedical science, dispensing, nursing, health studies from a recognised post-secondary institution and two years of relevant work experience; OR
  4. have equivalent qualifications.

 

If the degree or equivalent qualification is from an institution where the language of teaching and assessment is not English, applicants shall provide evidence of English proficiency, such as:

  1. an overall band of 6.0 or above with no subtests lower than 5.5 in the IELTS; or
  2. a score of 550 or above in the paper-based TOEFL, or a score of 213 or above in the computer-based TOEFL, or a score of 80 or above in the internet-based TOEFL; or
  3. HKALE Use of English at Grade E or above; or
  4. HKDSE Examination English Language at Level 3 or above; or
  5. equivalent qualifications.

 

Applicants who hold other qualifications, aged 21 or above and have relevant work experience will be considered on individual merit.

Apply

Application Form Download Application Form

Enrolment Method
Payment Method
1. Cash, EPS, WeChat Pay Or Alipay

Course fees can be paid by cash, EPS, WeChat Pay or Alipay at any HKU SPACE Enrolment Centres.

2. Cheque Or Bank draft

Course fees can also be paid by crossed cheque or bank draft made payable to “HKU SPACE”. Please specify the programme title(s) for application and applicant’s name. You may either:

  • bring the completed form(s), together with the appropriate course or application fees in the form of a cheque, and any required supporting documents to any of the HKU SPACE enrolment centres;
  • or mail the above documents to any of the HKU SPACE Enrolment Centres, specifying “Course Application” on the envelope. HKU SPACE will not be responsible for any loss of personal information and payment sent by mail.
3. VISA/Mastercard

Applicants may also pay the course fee by VISA or Mastercard, including the “HKU SPACE Mastercard”, at any HKU SPACE enrolment centres. Holders of the HKU SPACE Mastercard can enjoy a 10-month interest-free instalment period for courses with a tuition fee worth a minimum of HK$2,000; however, the course applicant must also be the cardholder himself/herself. For enquiries, please contact our staff at any enrolment centres.

4. Online Payment

Online application / enrolment is offered for most open admission courses (enrolled on first come, first served basis) and selected award-bearing programmes. Application fees and course fees of these programmes/courses can be settled by using "PPS by Internet" (not available via mobile phones), VISA or Mastercard. In addition to the aforesaid online payment channels, new and continuing students of award-bearing programmes with available online service, they may also pay their course fees by Online WeChat Pay, Online Alipay or Faster Payment System (FPS). Please refer to Enrolment Methods - Online Enrolment  for details.

Notes

  • If the programme/course is starting within five working days, application by post is not recommended to avoid any delays. Applicants are advised to enrol in person at HKU SPACE Enrolment Centres and avoid making cheque payment under this circumstance.

  • Fees paid are not refundable except under very exceptional circumstances (e.g. course cancellation due to insufficient enrolment), subject to the School’s discretion. In exceptional cases where a refund is approved, fees paid by cash, EPS, WeChat Pay, Alipay, cheque, FPS or PPS by Internet will be reimbursed by a cheque, and fees paid by credit card will be reimbursed to the credit card account used for payment. 

  • In addition to the published fees, there may be additional costs associated with individual programmes. Please refer to the relevant course brochures or direct any enquiries to the relevant programme team for details.
  • Fees and places on courses cannot be transferrable from one applicant to another. Once accepted onto a course, the student may not change to another course without approval from HKU SPACE. A processing fee of HK$120 will be levied on each approved transfer.
  • HKU SPACE will not be responsible for any loss of payment, receipt, or personal information sent by mail.
  • For payment certification, please submit a completed form, a sufficiently stamped and self-addressed envelope, and a crossed cheque for HK$30 per copy made payable to “HKU SPACE” to any of our enrolment centres.
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