A12. Medsafe updates
Tracks
Prescription Medicine Regulation
Wednesday, June 12, 2024 |
1:30 PM - 2:30 PM |
Pyrmont Theatre |
Chair & Speakers
Deborah Cooper
Chief Operating Officer
Adjutor
Chair: Medsafe Updates
Abstract
This session will provide an update on the Therapeutic Products Act repeal and what the next steps are, the work Medsafe is doing with Government to address its priorities and streamlines its proceses, and cover some hot topics such as innovation, international collaboration, IT upgrades and medicine shortages.
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.
Chris James
Group Manager
Medsafe
Medsafe updates
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.