International Regulatory Convergence for MTP Good Manufacturing Practice



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.


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

12:40 Lunch

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

16:00 Close