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