Over the last 20 years, Australia has grown to become a destination of choice for the conduct of early phase clinical trials. Rapid ethics approval and a simple notification to the Therapeutic Goods Administrations (TGA) means that from submission to FPFD it will only take on average 6 weeks. Coupled with the attractive R&D tax incentive program offered by the Australian Government, this swift pathway to study data can then be used to support an IND or IMPD application allowing companies to speed up their drug development process. Join PCI Clinical Services and their partners for this educational webinar to learn more and understand:
- The specific considerations required for Phase I trial design in Australia
- Australia’s R&D tax incentive program and eligibility when conducting your trials in Australia
- The specific requirements for importing, manufacturing, compounding and labelling your product for Australian clinical studies
Cameron Johnson, Chief Executive Officer and Managing Director, Nucleus Network Ltd
Cameron Johnson joined Nucleus Network in August 2013 as the Chief Operating Officer, before moving into the position of Managing Director. Prior to joining Nucleus Network, Cameron held the position of Chief Executive Officer at a Phase 1 Clinical Trials Organisation and was also the inaugural CEO of the company. Cameron has worked in early phase clinical trials organisations across Australia and Europe since 2001.
Craig Rogers, SVP of Asia Pacific, PCI Clinical Services
Craig has over 20 years of experience working within the pharmaceutical industry. This included roles in Regulatory Affairs at big pharma and local biotech; Scientific Affairs at IDT; and General Manager at both CMAX and Nucleus Network Phase I clinical units. In 2008, Craig established PPP, based on his gap analysis of the services available in the local market, to support clinical trial manufacturing and logistics. Craig is a registered pharmacist, toxicologist and lawyer.
Simone Quin, Partner, Prime Accounting and Business Advisory Services
Simone has over 20 years of experience in the business management of science and research, including positions within universities, government, collaborative research centres and in consulting. Simone has a Bachelor of Commerce degree from the University of Melbourne and a Graduate Certificate in Science and Technology Commercialisation from Adelaide University; a Graduate Diploma in Applied Corporate Governance and is a member of the Institute of Chartered Accountants.
Who Should Attend?
Senior professionals from Pharmaceutical, Biotechnology and Medical Device manufacturers involved in:
- Clinical supply chain/distribution/procurement
- Clinical packaging/labelling
- Clinical operations
- Quality assurance
- Regulatory affairs
What You Will Learn
Join PCI Clinical Services and their partners for this educational webinar to learn more and understand:
1. The specific considerations required for Phase I trial design in Australia
2. Australia’s R&D tax incentive program and eligibility when conducting your trials in Australia
3. The specific requirements for importing, manufacturing, compounding and labelling your product for Australian clinical studies
PCI Clinical Services
PCI Clinical Services – Excellence in Global Clinical Supply Chain Solutions – As a respected industry leader and trusted partner we provide a comprehensive range of outsourced pharmaceutical services that stretches all the way from early stage development to long-term commercial supply. This reputation is based on best-in-class technologies, cutting-edge research, an exceptional team of outstanding people and a consistent record of meeting the highest regulatory and quality standards. Equally important is our commitment to an exceptional customer experience and we share our customers’ passion for supplying lifesaving medicines to patients around the world. We’re committed to meeting their evolving needs by leveraging our experience and expertise to develop the best possible solutions to their drug development challenges.