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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