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.
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.
Day 1 - Prescription and non-prescription medicines
Therapeutic goods product development
The TGA and Therapeutic Goods Act
Important definitions and terminology
Australian Register of Therapeutic Goods
Access to unregistered therapeutic goods
Manufacturing for medicines
Day 2 - Prescription medicines
Good regulatory practice for prescription medicines
Maintaining products on the ARTG
Applications to register and vary prescription medicines
Adverse drug reactions or device incidents
Medical devices
Product recalls
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
Lynda Notting
Lynda is an accomplished regulatory affairs professional with experience in multi-national innovator and generic medicine companies. She has extensive experience in managing the full lifecycle of prescription medicines, OTC medicines and medical devices in Australia and New Zealand, where she has been responsible for the regulatory strategy, and preparation and assessment of regulatory documentation at all stages of the development cycle. Lynda also has extensive experience in NeeS and eCTD publishing. She has a Bachelor of Science and a Bachelor of Biomedical Science (Pharmaceutical Sciences). Lynda joined Commercial Eyes in 2016.
Upon completion of this course, attendees will receive 14 CPD points.
This is an entry level/introductory workshop. Anyone with relevant background/ degree in Science or Pharmacy or Engineering discipline or similar can attend this workshop. If you have any questions on your suitability for this workshop, do not hesitate to call the ARCS office on (02) 8905 0829.
Course fees (inc. GST):
ARCS member - $1415
Non-member - $2275
Registration terms and conditions
Please note that virtual workshops at ARCS cover the same content as the physical (face-to-face) workshop. The training material, exercises and student workbook have been redesigned to ensure that the same learning outcomes are achieved as traditional workshops.
This course runs for two full days.
Computer/laptop connected to power
Good internet access (1Mbps or better – broadband recommended)
A charged mobile phone and headphones (if using your phone for audio)
Phone charger – given the event goes all day, you will need a way of charging your phone
Headphones for computer audio (if using computer audio)
A quiet room/space
Before joining, be sure to check system requirements to avoid any connection issues
"Great course and the facilitator was very knowledgeable and very responsive. I would recommend this course to others." Quality Lead Asia Pacific, Amgen Australia Pty Ltd.
"Thank you, very helpful workshop." Student, Monash University.
"Very informative session." Pharmacist, Balwyn East Pharmacy.
"It was really informative and helpful. I look forward to attend more training programs and workshops." Student, University of Sydney.
"Excellent introduction to the world of Regulatory Affairs in Australia." Senior Quality Assurance Team Leader, Boehringer Ingelheim.
"The facilitator is great at what she does for work; I could tell by her instant responses and comprehensive knowledge." Student, Monash University.
I’m very very happy with the way the course was delivered. I will recommend other people as well to do this course." Quality Assurance Officer, Melrose Health.
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