Life & Health Sciences Pharmaceutical Studies
Certificate in Drug Safety and Pharmacovigilance
- Course Code
- Application Code
- QF Level
- Study mode
- Start Date
- 23 Feb 2018 (Fri)
- 10 months
- Course Fee
The programme provides students with a foundation in drug safety and pharmacovigilance principles so as to enable them to be competent in the field. Staff who are working in pharmaceutical production, import/export of pharmaceuticals, retailing and wholesaling of pharmaceuticals, procurement and supply of pharmaceutical products, pharmaceutical regulatory affairs department, risk communication for the drug safety and/or pharmaceutical education can apply.
The pharmaceutical industry suffered from the oversight of drug safety over the past few years. Although some well-prescribed drugs had been marketed for several years, they were withdrawn from the market due to a variety of serious, unexpected and/or adverse drug reactions found in patients.
In 2009, the Government set up the Review Committee on Regulation of Pharmaceutical Products to review the existing drug regulatory regime and to find out long-term measures to deal with the drug safety crisis, after a series of drug safety incidents found in Hong Kong1. The Review Committee then made a total of 75 recommendations2 to strengthen the pharmacovigilance and drug safety mechanisms in Hong Kong by using existing resources and soliciting new resources from the Government. One recommendation is to enhance the current Good Manufacturing Practice (GMP) licensing standards in pharmaceutical production to more stringent Pharmaceutical Inspection Co-operation Scheme (PIC/S) standards. Besides, the Pharmacovigilance and Risk Management Division is also established under the auspices of the Drug office of the Department of Health.
In view of the Review Committee’s recommendations and the raising of Adverse Drug Reaction (ADR) reporting awareness, there is an urgent need to equip staff in the pharmaceutical industry with up-to-date knowledge on drug safety and pharmacovigilance in order to cope with the most stringent requirements and regulations which set by both local and international regulatory authorities.
1Chan T. Y. K (2014) Pharmacovigilance in Hong Kong. In: Mann’s Pharmacovigilance. 3rd ed. John Wiley & Sons Ltd.
2Review Committee on Regulation of Pharmaceutical Products in Hong Kong. (2009). Report of the Review Committee on Regulation of Pharmaceutical Products in Hong Kong, Food and Health Bureau, Hong Kong.
Programme Intended Learning Outcomes
On completion of the programme, students should be able to:
- outline the basic principles of drug safety and pharmacovigilance;
- identify the key issues of drug safety in different phases of drug life cycle and in different vulnerable groups;
- give suggestions to pharmacovigilance teams in managing adverse events and adverse drug reactions by observing the international recognized procedures and guidelines on drug safety, pharmacovigilance and ADR reporting;
- support healthcare professionals in applying the pharmacovigilance programmes in different scenarios of major settings.
This programme consists of two modules:
Module 1: Principles of Drug Safety and Pharmacovigilance (50 Hours)
- Introduction to Pharmacovigilance
- Introduction to Adverse Drug Reactions
- Classification of Drugs and Diseases
- Current Pharmacovigilance Scenarios in HK and in the World
- Pharmacovigilance Terminologies and Coding
- Pharmacovigilance Programme in Different Settings
- Adverse Drug Reaction Reporting Systems
- Risk Assessment and Risk Management
- Seriousness Assessment Criteria
- Drug Informatics
- Pharmacovigilance Tools
- Pharmacoepidemiology and Pharmacovigilance
- Pharmacovigilance Communications
- Pharmacogenomics and the Genetic Basis of ADRs
Module 2: Pharmacovigilance Regulatory Affairs (50 hours)
- Safety Monitoring in Different Phases of Drugs’ Life Cycle
- Drug Safety in Vulnerable Groups: Children, Pregnant Women and Elderly People
- ICH Guidelines
- PIC/S and Pharmacovigilance
- Pharmacovigilance Organizations in Other Countries and Their Regulations
- Case Reporting Skills and Requirements
- Pharmacovigilance Quality Assurance, Inspection and Audit
- Handling of Legal Cases
- Pharmacovigilance and the Public Relations
- Case Studies
Each module should have an assignment, test and written examination.Days / Time
- Friday 7:00pm - 10:00pm
- 10 months (from late-February to mid-November 2017)
Applicants shall have attained:
1) an Ordinary Certificate in a related discipline; OR
2) HKDSE Level 2 or above in five subjects including English Language and one of the following science subjects: Biology, Chemistry, Physics, Combined Science, or Integrated Science; OR
3) HKCEE Level 2 / Grade E or above in English Language and FOUR passes in other subjects including one of the following science subjects: Biology, Chemistry, Physics, or Science and Technology; OR
4) equivalent qualifications.
Applicants who hold other qualifications but are aged 21 or above and have relevant work experience will be considered on an individual basis.
HK$150 HK$150 (non-refundable)Course Fee
- Course Fee : HK$12000
Application Form Download Application FormEnrolment Method
The completed application form with the relevant documents and application fee $150 should be submitted by the following methods on or before the deadline:
- by mailing to Pharmaceutical Studies, 13/F, Fortress Tower, 250 King's Road, North Point, Hong Kong (Attention to: Mr Danny Mak)
- in person at any of the HKU SPACE Enrolment Centres
Each application must be accompanied by the photocopied documents below:
- Academic certificates and transcripts
- HKID card or passport
Applicants will be asked to present HKID or passport for vertification if applying in person at enrolment counters or to attach a copy of HKID or passport if applying by post.
1. Cash or EPS
Course fees can be paid by cash or EPS at any HKU SPACE enrolment counters.
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 Pharmaceutical Studies, 13/F, Fortress Tower, 250 King's Road, North Point, Hong Kong (Attention to: Mr Danny Mak). HKU SPACE will not be responsible for any loss of payment sent by mail.
Applicants may also pay the course fee by VISA or MasterCard, including the “HKU SPACE MasterCard”, at anyHKU SPACE enrolment centres. Holders of the HKU SPACE MasterCard can enjoy a 10-month interest-freeinstalment 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.
For general and short courses, applicants may be required to pay the course fee in cash or by EPS, Visa or MasterCard if the course is to start shortly.
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, cheque or PPS (for online payment only) will normally be reimbursed by a cheque, and fees paid by credit card will normally be reimbursed to the payment cardholder’s credit card account.
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 transferred 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 approved transfers.
Receipts will be issued for fees paid but HKU SPACE will not be responsible for any loss of receipt sent by mail.
For additional copies of receipts, please send a stamped, self-addressed envelope with a completed form and a crossed cheque for HK$30 per copy made payable to ‘HKU SPACE’. Such copies will only normally be issued at the end of a course.
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