Australian jurisdictional update Dr Cheryl McRae Therapeutic Goods - PowerPoint PPT Presentation

Oct 24, 2023 •166 likes •209 views

Australian jurisdictional update Dr Cheryl McRae Therapeutic Goods Administration Premarket 1. Expert review of regulation of medicines and medial devices 2. IVD framework amendments 3. Up-classification of Class IIb joints 4. De-regulation

Australian jurisdictional update Dr Cheryl McRae Therapeutic Goods Administration
Premarket 1. Expert review of regulation of medicines and medial devices 2. IVD framework amendments 3. Up-classification of Class IIb joints 4. De-regulation agenda 5. International engagement 2
Post market 1. Development of a new Adverse Event Management System 2. Future work includes developing a web service to allow manufactures to report directly 3. Sentinel site pilot 4. Review/consultation with stakeholders about the Recall procedure guideline 3

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