A practical introduction to regulatory affairs.
This introductory course will provide you with an ideal grounding in regulatory affairs in Australia. It is a practical introduction to what therapeutic goods regulatory affairs is all about, and how it impacts on how therapeutic goods are developed, registered, marketed and maintained. Learn the ’what’, the ’how’ and the ’why’ of regulatory affairs through discussion, case studies and interactive workshop activities.
By the end of the course you will have a clear understanding of the Australian regulatory framework, specific requirements for different product types and how to complete some commonly required applications and activities. The practical nature of the workshop will help you to implement what you have learnt in your day to day role.
After the course, attendees may complete an online examination to demonstrate acquired knowledge and receive a certificate of completion.
Who should attend
- Anyone new to therapeutic goods regulatory affairs in Australia, whether currently employed in a role (less than 18 months experience) or preparing to embark on a regulatory career.
- Those who would like to transition to a regulatory career from another related field or students who would like to complement their theoretical knowledge with a practical workshop.
- Professionals working with regulatory affairs colleagues in the prescription medicines, over-the-counter, complementary medicines or medical devices industries or who could benefit from an understanding of the discipline.
Learning objectives
After attending this workshop, participants should be able to:
- Demonstrate familiarity with the TG Act and regulations, including the language style used and often referenced sections and subsections.
- Understand that regulatory affairs professionals interface with a number of other departments and roles and to be introduced to the processes and activities that lead to or require these interactions
- Identify therapeutic goods and understand the difference between prescription, OTC and complementary medicines and medical devices
- Describe GMP licensing and clearance requirements and their implications
- Undertake the listing of medicines on the ARTG
- Efficiently navigate the TGA website
- Describe the processes for registration of non-prescription and prescription medicines and be able to identify relevant scientific guidelines
- Assess common proposed changes to non-prescription and prescription medicines and determine variation data requirements
- Discuss the labelling requirements for non-prescription and prescription medicines, including PI and CMI
