Regulation of Health Products and The Practice of Pharmacy

Provided by NUS Academy of GxP Excellence


Course introduction

Introduction


Course Outline

This course gives an overview of the regulatory framework in Singapore for:
 
  • the manufacture, import and supply of health products (which generally includes any medical or health-related products for human use such as drugs and pharmaceuticals, herbal medicines, health supplements, medical devices and cosmetics); and
  • the practice of pharmacy and the pharmacy profession.
This course will also introduce the laws (that are currently in force) in Singapore that regulate dealings in health products (e.g. Health Products Act, Medicines Act) and the practice of pharmacy (i.e. Pharmacists Registration Act).

Target Audience

This course is intended primarily for persons seeking professional registration as pharmacists in Singapore who are sitting for the examination on pharmacy-related laws, set by the Singapore Pharmacy Council as a pre-requisite for registration.

This course will also be of interest to persons in the health products industry, and in particular those whose responsibilities involve handling the regulatory aspects of dealing with health products.

Learning Outcomes

Upon successful completion of this course, participants should have a basic understanding of the regulatory frameworks for health products and the practice of pharmacy in Singapore, and a working knowledge of the various laws that give effect to the regulatory controls in those areas.

Instructors

Mr Kelvin Tan and Ms Tan Mui Ling, Senior Lecturer, Department of Pharmacy, National University of Singapore

Kelvin Tan, B.Sc(Pharm), has over 13 years of experience in the field of health products regulation, having served with the regulatory bodies in Singapore’s Ministry of Health and Health Sciences Authority. He has extensive experience in regulatory enforcement as well as in the development of policies and legislation for the regulation of health products.

Content & Schedule
 
Session Topic No. Topic Title
29 March 2014

9am to 5pm
1 Basics of Legislation & Laws Regulating Health Products
2 Types & Categories of Health Products
3 Control of Dealers : Manufacturers & Importers
4 Control of Dealers : Wholesalers & Retailers
5 Pre-Market Controls on Health Products
6 Controls on Retail-Level Access – POM/P/GSL Classification
7 Documentation & Recording Requirements
5 April 2014

9am to 5pm
1 Product Presentation – Labelling & Packaging Requirements
2 General Prohibitions & Post-Market Duties of Dealers
3 Controls on Advertising & Promotion of Health Products
4 Specialised Aspects : Control of Clinical Trials
5 Specialised Aspects : Narcotics & Psychotropic Substances
12 April 2014

1pm to 5pm
(Optional for non-Pharmacists)
1 Pharmacists Registration Act
2 Code of Ethics for Pharmacists

Pharmacy Continuing Education Category 1B points will be awarded for attending the course.

Fees:
S$642 per participant inclusive of 7% GST.

Special discounts for foreign trained pre-registration Pharmacists preparing for the Singapore Pharmacy Council Forensic Examinations:
S$428 per participant inclusive of 7% GST.

Registration closes 15 March 2014.

Here’s what participants say:
“The instructors are able to communicate the topics in a way that ease my understanding.”

“The instructors are very clear, concise and detailed. They are able to direct us to where to look for the supporting facts in the Act/Rules etc.”

“The exercise and case studies are very useful and helped me to understand the topic more in-depth.”

“Useful and excellent refresher course for pharmacists and any person in the regulatory arena. Instructors are very clear and examples and exercises are very relevant.”

“It’s good to attend the course, I learnt a lot”



Fees & Funding

Please enquire below for course fees and financial grants:




Brochure


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