You are here

TGA Internet site archive

The content on this page and other TGA archive pages is provided to assist research and may contain references to activities or policies that have no current application. See the full archive disclaimer.

TGA business plan 2013-2014

Therapeutic Goods Administration

19 December 2013

Book pagination

Risk

The TGA has identified the following risks as its highest rated.

Risk Risk mitigation strategies
Insufficient capacity to absorb changes across the organisation and maintain effective business operations
  • Closely monitoring progress of TGA Blueprint for reforms
  • Adoption of an appropriate change management framework
  • Workforce plan in place
  • Redevelopment of IT infrastructure and information management systems
  • Communications and education framework and strategies for management of stakeholder expectations
Failure to meet major stakeholders' expectations
  • Implementation of public contact strategy
  • Framework for customer, health professional and industry stakeholder engagement
  • Standard procedures in place to address responses for enquiries and customer service and provision of timely and accurate advice to stakeholders, in accordance with Customer Service Standards
  • Clearer articulation of Regulatory guidelines
  • Development of wider sponsor access to eBusiness
  • Monitoring of international best practice
  • Risk based review and implementation of Audit schedule
  • Risk based review and implementation of Laboratory testing program
Misalignment between law, processes and guidance documents
  • Regular review of processes to ensure alignment with legislation and proper administrative good practice
  • Regular review and update of regulatory guidelines
  • Review of regulatory guidance documents and SOPs
  • Adequate allocation of resources for decision making and training for decision makers
  • Finalise legal elearning modules
  • Information on the TGA website updated and reviewed regularly
  • Use of Business Process Management to align process with legislation
Inability to retain and recruit capable staff
  • Review of learning and development
  • Regular review of the recruitment model in meeting the TGA's business
  • Proactive approaches to making the TGA a good place to work
  • Adoption of an appropriate change management framework
Lack of appropriate preparation for ANZTPA
  • Adequate implementation of agreed projects for which TGA is responsible
  • Contribute to development of options about governance and employment structure
  • Adequate staff consultation and effective communication
  • Adoption of an appropriate change management framework
  • Ensure appropriate expertise is available to the implementation team

Book pagination