A19. Crossing the Tasman: Insights into navigating the NZ regulatory terrain
Tracks
Prescription Medicine Regulation
Wednesday, June 12, 2024 |
2:45 PM - 3:45 PM |
Parkside 1 |
Chair & Speakers
Deborah Cooper
Chief Operating Officer
Adjutor
Chair: Crossing the Tasman: Insights into navigating the NZ regulatory terrain
Abstract
The New Zealand regulatory environment is currently in a state of flux, with a significant remodel likely to be on the way within the next few years. In light of these uncertainties, this session will delve into important considerations for operating within the current regulatory framework and how to plan your activities in New Zealand. We will cover key considerations from an industry perspective, such as sponsorship set up arrangements, import and GMO requirements, submitting high quality regulatory applications, and NeeS/eCTD formatting decisions. Chris James from Medsafe will also join us to discuss regulatory strategies for New Zealand, and provide us with insight into new application pathways that may soon be on offer.
Biography
Deb is Adjutor’s Chief Operating Officer and a project management expert with a passion for finding pragmatic solutions to complex problems. She has extensive experience in therapeutic product development, regulatory affairs, and commercialisation with significant proportion of her career spent in senior roles in pharmaceutical innovator companies and Australian and international consultancies.
Throughout her career, Deb has established a reputation for coordinating large numbers of projects simultaneously, maintaining a very broad local and international industry network, and gaining extensive experience working in close collaboration with regulators.
At Adjutor, she seamlessly switches between managing operations and delivering a wide range of projects, consistently exceeding clients' expectations and foreseeing issues in projects while finding creative solutions and workarounds. She is respected for understanding complicated concepts quickly and translating them into terms others can understand.
Deb’s thirst for knowledge has driven her to gain several qualifications. Most recently, she completed the AICD Company Directors Course with Order of Merit to build on her experience and continue to promote an innovative culture for sustainable growth.
Madie Clarke
NZ Manager
Adjutor Healthcare Pty Ltd
Crossing the Tasman: Insights into navigating the NZ regulatory terrain
Biography
Based in New Zealand, Madie has spent her career to date leading projects in regulatory affairs, clinical development and medical writing in the pharmaceutical industry. With extensive experience in the regulatory environments of Australia and New Zealand, Madie has worked on a wide range of medicines and medical devices across varying therapeutic areas, including pain, COVID-19, oncology and a number of orphan diseases. Working with partners from around the world, Madie has collaborated on projects at all stages of a product’s lifecycle - from product development, clinical trials and dossier compilation, through to regulatory approval, commercialisation and post-market maintenance.
Having also led projects for the US, Canada, EU and Asia, Madie is adept at utilising knowledge of the global regulatory context to inform and optimise clinical, regulatory and commercial strategies for Australia and New Zealand. Most recently, Madie has been involved in a number of time-sensitive, fast-paced applications for prescription and biological medicines, including provisional and priority pathway applications, and agency work-sharing initiatives such as Project Orbis, in addition to providing strategic input into nonclinical and clinical development for early-stage advanced therapies.
Chris James
Group Manager
Medsafe
Crossing the Tasman: Insights into navigating the NZ regulatory terrain
Biography
Chris is the Group Manager of Medsafe, the medicine and medical device regulator in New Zealand. Chris is also the Group Manager for the Medicinal Cannabis Agency.
Chris is a registered pharmacist and holds post graduate qualifications in public health. In 2006 he joined Medsafe, initially in the pharmaceutical chemistry assessment of new medicines, then moving to the post market pharmacovigilance team.
Chris has experience in risk communication including developing the early warning and alert system to provide information about new and emerging safety issues.
Chris has been Medsafe Group Manager since 2015.