HUBS3415Regulatory skills for the Pharmaceutical and Therapeutic Goods Industries

Course handbook

Description

Employers in pharmaceutical, therapeutics, and medical technologies prefer to hire staff who are future-ready; who have a working knowledge and understand the regulations applied to the research, development and manufacturing of pharmaceuticals, therapeutics, foodstuffs, and personal use products. While this may appear to add complexity to the manufacture and marketing of these products, it ensures that the product is safe, effective and meets a minimum measure of quality. Whether you wish to work in a large multinational enterprise, small-medium enterprise, or your own small business, you will need to be aware of the relevant statutory regulations, understand how to comply with these obligations and assure that your product is safe, effective, and able to be sold in relevant markets!This course is designed to introduce you to the statutory regulations applied to the development, evaluation, manufacture, storage, distribution, and post-marketing vigilance of pharmaceutical and therapeutic products in clinical and consumer sectors, expanding your core knowledge and providing career flexibility between these sectors. In this course you will be shown how to identify and find the relevant regulatory framework that applies to specific industries, how to comply with regulatory oversight, and how to ensure that your manufactured goods meet consumer expectations. You will be exposed to strategies and practical solutions to help meet these commercial–legal obligations, contemporary manufacturing standards, and to assure the quality and safety of pharmaceutical, therapeutic and consumer products. This course will focus on contemporary regulations applied in the Indo-Pacific and SE Asia (APEC, ASEAN) regions.

Availability2024 Course Timetables

Learning outcomes

On successful completion of the course students will be able to:

1. Outline and explain the ethical obligations, OECD-mandated regulations, and rationale underpinning the regulatory requirements in the good manufacturing practice (GMP) for pharmaceuticals and therapeutics.

2. Provide advice on how to implement. meet and maintain Quality Management Systems, consistent and efficient product manufacture and delivery, and ensure compliance with ISO and GMP standards.

3. Identify, evaluate and rectify non-compliance and deviations from QMS/ISO/GMP in the manufacture of pharmaceuticals, therapeutics, and foodstuffs.

4. Justify and effectively communicate with other stakeholders in the pharmaceuticals and therapeutics sector.

Content

• The 'why; the 'what', and the 'how' of Regulations applying to Therapeutic Goods (Medical Technology, Pharmaceuticals, and Food Technology) sold in major Indo-Pacific and SE Asia markets.
• Introduction to Medical Technology, Pharmaceutical and Food Technology Research & Development pipelines.
• Manufacturing Therapeutic Goods - ISO/OECD/PIC/s
• ICH Harmonisation - Q7/Q8 GLP/GMP/GCP
• Over-the-counter medicines
• Prescription (non-OTC) and Scheduled medicines
• Biotherapeutics, Biosimilars, Cell-based therapies, Personalised medicine
• Combination Therapeutics
• Satisfying TGA (Australia), Medsafe (New Zealand), HSA (Singapore), CFDA (China) and CDSCO (India) requirements
• Quality assurance systems in Medical Technology, Pharmaceuticals and Food Technology
• Pharmacovigilance and Post-marketing
• Responding to non-compliance and deviations

Assumed knowledge

Knowledge of standard biological/chemistry laboratory safety protocols.

Assessment items

Written Assignment: Assessment 1

Written Assignment: Assessment 2

Written Assignment: Assessment 3

Contact hours

Semester 1 - 2024 - Online

Course outline

Course outline not yet available.