About the Event
This April, Melbourne is playing host to the Participating Authorities from the Pharmaceutical Inspection Co-operation Scheme (PIC/S), a non-binding, informal co-operative arrangement between 49 international Regulatory Authorities in the field of Good Manufacturing Practice (GMP). The closed event aims to harmonise inspection procedures worldwide by developing common standards and providing training opportunities to inspectors.
MTPConnect—the medical technology, biotechnology and pharmaceutical (MTP) Industry Growth Centre—is taking this opportunity to connect the Australian sector to directly engage with participants from the PIC/S event.
The International Regulatory Convergence for MTP GMP will provide pharmaceutical manufacturers with an opportunity to directly engage with PIC/S representatives, including the Food and Drug Administration (FDA, United States), Medicines and Healthcare Products Regulatory Agency (MHRA, United Kingdom), and the Therapeutic Goods Administration (TGA, Australia), as well as industry leaders and government representatives.
Presenting on industry perspectives and innovations in regulatory compliance, the representatives will provide updates and guidance on future regulatory direction in their respective markets, present on international GMP hot topics such data integrity and quality metrics, as well as provide insight into opportunities for closer alignment and convergence of regulatory systems to allow for more effective and streamlined processes.
Register now to join representatives from the MTP manufacturing sector to share learnings, best-practice, and successes.
JOIN THE CONVERSATION: #MTPConnect #APIconverge
This event is facilitated by MTPConnect, in conjunction with the Australian Government Entrepreneurs' Programme, Victorian Department of Economic Development, Jobs, Transport and Resources, ARCS Australia, AusBiotech, BioMelbourne Network.
08.30 Arrival and Refreshments
09:00 The Hon Vicki Ward MP, Parliamentary Secretary of Industry and Skills, Vic
09:05 Welcome & MTPConnect overview - Sue MacLeman, CEO, MTPConnect
09:10 Australian GMP Regulatory Context - Harry Rothenfluh, TGA
09:20 EU-FDA MRA and impacts for Australia - Graeme McKilligan, UK MHRA
09:45 US FDA ‘Quality Cultures’ - Alicia Mozzachio, US FDA
10:10 Data Integrity - Gaye Camm, TGA
10.30 Data Metrics - Jenny Hantzinikolas, TGA
10:45 Morning Tea
11:10 The Patient Perspective of additive manufacturing - Paul S D'Urso, Executive Chairman Anatomics
11:30 Organisation Quality Culture beyond KPIs: Capability assessment models - Edward Jones, Senior Director Global Quality Systems - CSL Behring
11:50 International Regulatory Convergence: Is Enough Being Done? An Australia perspective - Tony Gould, PharmOut
12:10 Regulatory convergence opportunities and challenges in Advanced therapy medicinal product manufacturing - Dominic Wall, Chief Scientific Officer, Cell Therapies
13:30 Entrepreneur Programme grant info for business - Ashley Bates, Aus Industry EP
13:50 Victorian State Govt programs - Andrew Wear, Victorian DEDJTR
14:10 Continuous Improvement & Business Continuity - John Montalto, Director, Quality Assurance Systems, CSL Behring
14:35 Quality Analytics, using Business Intelligence - Matthew Schoerie, QikSolve
15:05 An end to end perspective of the manufacture and sale of Australian complementary medicines - Clare Barker, Nutrition Care Pharmaceuticals
15:30 Afternoon Tea - Networking