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BioForum: Regulatory Essentials for Medtech Manufacturing
May 30, 2023 @ 7:30 am - 10:00 am AEST
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For a more in-depth look at this topic, take a deep-dive into medtech manufacturing with our masterclass program Concept to Creation: The Roadmap to Medtech Manufacturing. The program includes this BioForum along with a full-day workshop and one-on-one advisory session.
About the BioForum
To bring safe, compliant medical devices to market, understanding regulatory requirements for product design and manufacture is crucial.Through a local and global lens, this BioForum will provide an overview of regulatory essentials for legal manufacturers and medtech enterprises, examining key compliance considerations and why traceability and maintaining evidence is so important.Leading manufacturer, Invetech will further examine the regulatory environment for onshore device manufacturing and highlight requirements as an operating ISO 13485 facility.Sharing the journey of MeMed (Israel), Dr Oren Zarchin will share his insights and lessons learnt working with the FDA, challenges faced for novel device development, manufacture and clinical studies, and meeting compliance for US market access.Don’t miss this opportunity to learn from leading industry experts to optimise your manufacturing pipeline.
The BioForum is a stand-alone event as well as Part A of the masterclass program. Masterclass participants are not required to register separately to attend.
Event details:
Date: Tuesday 30 May 2023
Time (AEST):
7:30am: Registration, tea & coffee
7:30am – 8:30am: Networking breakfast (in person only)
8:30am – 9:30am: Presentations (live streamed)
9:30am – 10:00am: Panel and Q&A (live streamed)
Venue: ACMI, Swinburne Studio, Federation Square, Melbourne VIC 3000
Format: Hybrid – in-person and online.
Host: Jeff Malone, CEO, BioMelbourne Network
Registration (BioForum only):
In-person: Members $85; Non-Members $175
Online: Members $25; Non-Members $45
Cancellation policy for BioForum:
In person registration
- Full refund given up to 7 days prior to the event
- No refunds within 7 days of the event
Online registration
- Full refund given up to 3 days prior to the event
- No refunds within 3 days of the event
Unsure if your organisation is a member? Check our member directory
Kindly sponsored by the State Government of Victoria
Dr Esther Apos, Director, CMS SciDoc
Dr Esther Apos completed her Ph.D in Biochemistry in 1992 through the Faculty of Veterinary Science at the University of Melbourne.
Over the past twenty years, she has worked in academic and commercial research, pharmaceutical and medical device product development, clinical trials, and regulatory compliance and affairs.
Dr Apos has worked with numerous biotech, medical device and cosmetic companies, developing their product documentation and dossier registration.
Industry Experience
- Pharma
- Biotech Start Ups
- MedTech Start Ups
- Clinical Registries
- Medical Devices
Extensive Experience in:
- Data management
- Data Analysis
- Project Management
- Clinical Evaluation Reports
- Medical and Technical Writing
- Clinical and Scientific Research
- Medical Device Quality Management Systems
Over the past twenty years, she has worked in academic and commercial research, pharmaceutical and medical device product development, clinical trials, and regulatory compliance and affairs.
Dr Apos has worked with numerous biotech, medical device and cosmetic companies, developing their product documentation and dossier registration.
Industry Experience
- Pharma
- Biotech Start Ups
- MedTech Start Ups
- Clinical Registries
- Medical Devices
Extensive Experience in:
- Data management
- Data Analysis
- Project Management
- Clinical Evaluation Reports
- Medical and Technical Writing
- Clinical and Scientific Research
- Medical Device Quality Management Systems
Jamila Bird, Program, Manager Invetech
Jamila is a passionate leader, problem solver and champion of continuous improvement.
She has delivered significant business value by leading the:
- Implementation of a new ERP (SAP)
- Development of a Covid PCR diagnostic instrument from alpha prototype to pilot production build within 10 months
- FPY improvement of a recently launched product from 45% to 90%
Jamila has facilitated over 30 continuous improvement events using a variety of business tools.
She has delivered significant business value by leading the:
- Implementation of a new ERP (SAP)
- Development of a Covid PCR diagnostic instrument from alpha prototype to pilot production build within 10 months
- FPY improvement of a recently launched product from 45% to 90%
Jamila has facilitated over 30 continuous improvement events using a variety of business tools.
Gerald Kent, Vice President, Cell Therapies and Diagnostics Invetech
Gerald has more than 25 years of global experience in end-to-end research and development projects in a technical, strategic and portfolio management capacity in the automotive sector and in the biomedical design and engineering sectors. Prior to joining Invetech, he spent more than 12 years in R&D with the Toyota Technical Centre in Australia. Over the course of his career, Gerald has led numerous successful development programs to deliver winning products to market.
As Vice President, Diagnostics & Cell Therapy, Gerald is actively driving Invetech’s business to continue ensuring positive outcomes for clients, fostering innovation and improved product design.
Gerald has a double Bachelor’s degree in Engineering (Mechanical and Computer Science) from Monash University and an MBA from the Australian Institute of Business.
As Vice President, Diagnostics & Cell Therapy, Gerald is actively driving Invetech’s business to continue ensuring positive outcomes for clients, fostering innovation and improved product design.
Gerald has a double Bachelor’s degree in Engineering (Mechanical and Computer Science) from Monash University and an MBA from the Australian Institute of Business.
George Loizou, Director, CMS SciDoc
George Loizou has worked in the pharmaceutical, complimentary medicine, cosmetic, medical device and IVD areas for the past 20 years.
George has extensive experience in product development and quality management systems for all medical device and IVD classes, software as a medical device (SaMD) and the respective technical file dossiers (CE, TGA, FDA). He is also a medical device certified lead auditor for Global European Notified Bodies auditing MDD/MDR, MDSAP and ISO 13485.
Industry Experience:
- Pharma
- Listed & registered medicines
- Cosmetics
- Medical devices (active, non-active, drug/device combinations)
- IVDs
Extensive experience in:
- Product development
- Quality management systems for all medical device and IVD classes,
- Software as a medical device (SaMD)
- Technical file dossiers (CE, TGA, FDA).
George has extensive experience in product development and quality management systems for all medical device and IVD classes, software as a medical device (SaMD) and the respective technical file dossiers (CE, TGA, FDA). He is also a medical device certified lead auditor for Global European Notified Bodies auditing MDD/MDR, MDSAP and ISO 13485.
Industry Experience:
- Pharma
- Listed & registered medicines
- Cosmetics
- Medical devices (active, non-active, drug/device combinations)
- IVDs
Extensive experience in:
- Product development
- Quality management systems for all medical device and IVD classes,
- Software as a medical device (SaMD)
- Technical file dossiers (CE, TGA, FDA).
Dr Oren Zarchin, Vice President, Research & Development MeMed (Israel)
Oren is a highly experienced leader of Product Development in global corporations, with more than 20 years of business and academic experience in the medical and semiconductors industries. Oren is currently the Vice President of Research & Development at MeMed, a medical technology company.
In his previous role, Oren served as Vice President, Product Development and executive management at Mazor Robotics LTD. Following Mazor's acquisition by Medtronic PLC, he served as Vice President, Product Development at Medtronic, leading Research & Development and Product Management.
Prior to Medtronic, Oren held various leadership positions at Philips Healthcare where he led multi-disciplinary Research & Development teams and product platforms in the US and Israel.
Oren has a Ph.D. in Physics from the Weizmann Institute of Science, M.Sc. (summa cum laude) in Physics and B.Sc. (cum laude) in Computer Science and Physics from Tel-Aviv University. He holds 15 patents and is the co-author on multiple publications.
In his previous role, Oren served as Vice President, Product Development and executive management at Mazor Robotics LTD. Following Mazor's acquisition by Medtronic PLC, he served as Vice President, Product Development at Medtronic, leading Research & Development and Product Management.
Prior to Medtronic, Oren held various leadership positions at Philips Healthcare where he led multi-disciplinary Research & Development teams and product platforms in the US and Israel.
Oren has a Ph.D. in Physics from the Weizmann Institute of Science, M.Sc. (summa cum laude) in Physics and B.Sc. (cum laude) in Computer Science and Physics from Tel-Aviv University. He holds 15 patents and is the co-author on multiple publications.
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