Industry Information and Education Session in Sydney on 1 June 2015

The first of the Industry Information and Education Session for 2015 and 2016 was held in Sydney on 1 June 2015. The program for the session is outlined below.

Opening session (all participants)

  • Welcome from the CEO and an outline of the day
  • The APVMA 2016 and beyond
  • Administrative plans to manage applications caught by transitional arrangements —what to expect from the APVMA

Providing Assistance (smaller groups)

  • An update on pre-application assistance—processes, fees and expectations
  • The difference between a general enquiry, pre-application assistance and an item 25 application?

From Preliminary Assessment to Registration (smaller groups)

  • Demystifying the processes and what to expect from the APVMA as applications progress

Making an application (smaller groups)

  • Data requirements, quality and making the scientific argument—what people need to know when preparing and compiling information for an application
  • An update on reference products, CCI and notifiable variations

Computer based learning—these sessions will be at a computer (smaller groups)

  • Navigating the online application
  • Dashboard features
  • The new security module

Chemical review (smaller groups)

  • New legislation and transitioning current reviews to the new work plan and timeline requirements
  • An update on the chemical review ‘prioritisation’ process and consultation
  • Chemical review plenary discussion

Regulatory science – strategy and developments

  • Establishment of the Office of the Chief Scientist
  • What is regulatory science?
  • Communicating regulatory science
  • Developing a science strategy
  • Improving existing and adopting new risk assessment methodologies

Closing session (all participants)

  • An update on the regulator performance framework project
  • Progress on consultation on an international assessments policy
  • Closing remarks from the CEO

For future session please visit our events page

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