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Healthcare, Sport and Wellness Pharmaceutical Studies
Certificate for Module (Regulatory Systems of Pharmaceutical Products and Medical Devices in the Greater Bay Area)
- Course Code
- HS227A
- Application Code
- 2260-HS227A
- QF Level
- Credit
- 9
- Study mode
- Part-time
- Start Date
- To be advised
- Duration
- 30 hours
- Language
- English
- Course Fee
- HK$9500
- Enquiries
-
3762009625718480
Programme Overview
Highlights
On completion of the programme, students should be able to
- outline the registration process and requirements of pharmaceuticals and medical devices under the jurisdictions of the NMPA, DH and SSM.
- establish key points of agreement and validation criteria with contract manufacturing organisations (CMOs) in the Mainland.
- 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.
- discuss the impact of legal requirements on import/export, sales and marketing of pharmaceuticals and medical devices in the Mainland.
- 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 & Entry Requirements
Fee
HK$150 (Non-refundable)
Course Fee- Course Fee : HK$9500
Entry Requirements
Applicants should
- 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
- 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
- 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
- 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:
- an overall band of 6.0 or above with no subtests lower than 5.5 in the IELTS; or
- 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
- HKALE Use of English at Grade E or above; or
- HKDSE Examination English Language at Level 3 or above; or
- 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 MethodOnline Enrolment
HKU SPACE provides 24-hour online application and payment service for students to apply to selected award-bearing programmes and to enrol in most open admission courses (courses enrolled on a first come, first served basis) via the Internet. Applicants may settle the payment by using either "PPS by Internet" (not available via mobile phones), VISA or Mastercard online. Online WeChat Pay, Online AliPay and Faster Payment System (FPS) are also available for continuing enrolment in the same programme, if online service is offered.
For first time enrolment
-
Complete the online application form
Applicant may click the icon
on the top right-hand corner of the programme/course webpage to make online application, and then follow the instructions to fill in the online application form.
Some programmes/courses may admit by selection, and may require applicants to provide electronic copy of any required documents (e.g. proof of qualification) as indicated on the programme/course webpage. Only file format in doc, docx, jpg and pdf are supported. -
Make Online Payment
Pay the application or programme/course fees by either using:
"PPS by Internet" - You will need a PPS account and a PPS Internet password. For information on how to open a PPS account and how to set up a PPS Internet password, please visit http://www.ppshk.com.
*Credit Card Online Payment - Course fees can be paid by VISA or Mastercard including the “HKU SPACE Mastercard”.
* HKU SPACE Mastercard cardholders who wish to enjoy 10-month interest free instalment scheme must pay their tuition fees in person at any of our HKU SPACE Enrolment Centres.
To know more about first-time online application/enrolment and payment, please refer to the user guide of Online Application / Enrolment and Payment:
For continuing enrolment in the same programme
Selected programmes offer online continuing enrolment service. Programme staff will inform students if they offer this service and offer further enrolment details.
Online Payment can be made via "PPS by Internet" (not available via mobile phones), VISA or Mastercard, Online WeChat Pay, Online AliPay and Faster Payment System (FPS)
In Person / Mail
For first time enrolment
-
For first come, first served short courses, complete the Application for Enrolment Form SF26 and bring or post the completed form(s), together with the appropriate application/course fee(s) and any required supporting documents to any of the HKU SPACE enrolment centres.
[Download Enrolment Form SF26] -
Award-bearing and professional courses may require other information. Forms are usually available at the enrolment centres or on request from programme staff. Bring or post the completed form(s), together with the appropriate application/course fee(s) and any required supporting documents to any of the HKU SPACE enrolment centres.
For continuing enrolment in the same programme
-
The standard ‘Enrolment/Payment Slip’ is designed for students of award-bearing programmes or remaining programmes in a suite of programmes requiring continuing enrolment and it applies to most programmes.
-
Students should complete the “Enrolment/Payment Slip” which will be made available by relevant programme staff and return the slip to any HKU SPACE enrolment centre or post it to the relevant programme staff with appropriate fee payment.
Please refer to available Payment Methods for fee payment information. If you are in doubt about the procedures, please check the individual course details, or contact our programme staff or enrolment centres.
Please note the followings for programme/course enrollment:
- To make an application online, you will need a computer with connection to the Internet and a web browser with JavaScript enabled. Google Chrome is recommended.
- Applicants should not leave the online application idle for more than 10 minutes. Otherwise, applicants must restart the application process.
- Only Early Bird Discount is supported for Online Applicants (Application). To enjoy other types of discount, please visit one of our enrolment centres.
- During the online application process, asynchronous application and payment submission may occur. Successful payment may not guarantee successful application. In case of unsuccessful submission, our programme staff will contact you shortly.
- Applicants are reminded that they should only apply for the same programme/course once through counter or online application.
- For online enrolment, a payment confirmation page would be displayed after payment has been made successfully. In addition, a confirmation email would also be sent to your email account. You are advised to keep your payment confirmation for future enquiries.
- Fees paid are not refundable except as statutorily provided or under very exceptional circumstances (e.g. course cancellation due to insufficient enrolment).
- If admission is by selection, the official receipt is not a guarantee that your application has been accepted. We will inform you of the result as soon as possible after the closing date for application. Unsuccessful applicants will be given a refund of programme/course fee if already paid.
Disclaimer
The School provides a platform for online services for a selected range of products it offers. While every effort is made to ensure timeliness and accuracy of information contained in this website, such information and materials are provided "as is" without express or implied warranty of any kind. In particular, no warranty or assurance regarding non-infringement, security, accuracy, fitness for a purpose or freedom from computer viruses is given in connection with such information and materials.
The School (and its respective employees and subsidiaries) is not liable for any loss or damage in connection with any online payments made by you by reason of (i) any failure, delay, interruption, suspension or restriction of the transmission of any information or message from any payment gateways of the relevant banks and/or third party merchants for processing credit/debit/smart card or other payment facilitation mechanism; (ii) any negligence, mistake, error in or omission from any information or message transmitted from the said payment gateways; (iii) any breakdown, malfunction or failure of those gateways in effecting online payment service or (iv) anything arisen out of or in connection with the said payment gateways, including but not limited to unauthorised access to or alternation of the transmission of data or any unlawful act not permitted by the law.
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
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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.
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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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