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To see to see a list of events currently scheduled go to the 'Register' page and search for the relevant course. If you cannot find the course you are looking for and would like to know when it will next be run, please contact the ARCS Events Coordinator at training@arcs.com.au.

Regulatory Affairs

Introduction to Australian Regulatory Affairs

Duration:

3 Days

Who Should Attend:

People with no experience (or less than six months experience) in regulatory affairs in Australia and people working in or interested in regulatory affairs roles in the prescription medicines, over-the-counter, complementary medicines or medical devices industries.

Course Overview:

This introductory course will provide you with practical training in what regulatory affairs is all about, how therapeutic goods are developed, registered and marketed and what legislative controls underpins such activities, and who regulates what. Learn the 'what', the 'how' and the 'why' of regulatory affairs.

Course Highlights:

Day 1 Regulatory Affairs as a discipline Product development process Developing Ebola treatment? Discovery through to sale Role of TGA Legislation governing the supply of therapeutic goods in Australia Who's who in the Therapeutic Goods Administration Day 2 Manufacturing and GMP Application process, procedures, appeals Maintaining registrations Advertising Recalls Access to unregistered products Adverse drug reaction reporting Medical devices (including device classification and application process and procedures) Day 3 GMP for medicines Applications to register prescription medicines Applications to register non - prescription medicines Labeling Product information Consumer medicine information

Entry Criteria:

This is an entry level/introductory course. There are no entry criteria for this workshop. If you have any questions on your suitability for this course, do not hesitate to call the ARCS Business Office.

Important Information:

ARCS Australia is committed to ensuring advertised educational events go ahead. Despite all our efforts, occasionally, some events will need to be postponed or cancelled due to lack of attendee numbers. This decision is made in conjunction with the event Chairperson. Your early registration for events will assist us to assess the interest for this event in your state. We recommend for interstate travel that flexible travel arrangements are made until the event has been confirmed as ARCS Australia will not be held responsible for forfeited costs. With your support we are committed to delivering these events, so please submit your registration early.

Refunds, Transfers and Cancellations: No refunds, transfers or cancellations will be accepted within two weeks of the event. Cancellations and transfers must be in writing and will incur a 10% administration fee. Substitutions are allowed at any time and at no cost.

 

How to Register for Events

Members

  • Visit www.arcs.com.au
  • Click "Member Login" at the top of the screen
  • Enter your username and password and click "Submit"
  • Click "Training" and "Register"
  • Select the criteria - or leave blank to see all courses available
  • On the results page you can
    • click the name of the course to see more information about the course OR
    • to register for course/s, tick the box next to the course name, and click "Add to My Choices" then "Register Now"
      • The member rate will automatically be applied
  • Enter your payment details and click "Submit" (Payment must be made by credit card unless you have a prior arrangement with ARCS)
  • Once you have completed Step 6 you will be emailed a confirmation and tax invoice. A final confirmation will be sent once the course is confirmed.

Non-Members

  • Visit www.arcs.com.au
  • Click "Training" and "Register"
  • Select the criteria or leave blank to see all courses available
  • On the results page you can:
    • click the name of the course to see more information about the course or
    • Register for course/s, by clicking the tick the box next to the course name, and click "Add to My Choices" then "Register Now"
      • The non member rate will automatically be applied as you have not logged in as a member
  • Enter your contact details and click "Submit"
  • Enter your payment details and click "Submit" (Payment must be made by credit card unless you have a prior arrangement with ARCS)
  • Once you have completed Step 6 you will be emailed a confirmation and tax invoice. A final confirmation will be sent once the course is confirmed.

Please note: The CONCESSION rate is for Student and Retired ARCS Members only.