Overwhelmed by the intricacies of obtaining regulatory approval for your medical device?

Bringing medical devices to market requires a thorough understanding of regulatory landscapes, both domestically and internationally. To guide you on this journey, our next Jumar Masterclass features industry experts who will unravel the complexities, provide practical insights, share proven strategies, and answer any questions you may have.

The speakers:

David Batka PhD — Senior Consultant Adjutor Healthcare

David has extensive regulatory affairs experience with medical devices in the Asian-Pacific region. David holds a Chemistry PhD from University of Debrecen, Hungary with close to 10 years of regulatory affairs experience while working for small and large, international pharmaceutical companies in Europe and Australia. With a technical and manufacturing expert background, David has utilised his skills facilitating the registration of a wide range of devices including IVDs. He has industry experience on the full range of device risk classifications. David has successfully managed several new TGA conformity assessment applications and new device registrations and is experienced in the post-market vigilance activities.

A/Prof Christiane Theda PhD — Co-Founder, Director, and Chief Medical Officer of Navi Medical Technologies

Educated in Germany (Cologne) and the USA (Johns Hopkins), Christiane is a specialist in Newborn Medicine and Medical Genetics. In addition to her medical degree, Christiane holds a doctorate in Physiological Chemistry (Cologne) and an MBA from Johns Hopkins. After years on faculty at John Hopkins, she relocated to Melbourne in 2009 where she is a neonatal specialist at the Royal Women’s Hospital and a neonatal transport specialist at the Royal Children’s Hospital. She holds honorary appointments at the University of Melbourne and the Murdoch Children’s Research Institute. Associated with several start-up companies, Christiane is involved in projects to develop new medical devices for neonatal and paediatric care; including an FDA submission and regulatory trial in 2024.

Key Areas We'll Explore:

1. Overseas-insight into United States, Europe and the emerging Asian Market.

2. Finding the right regulatory partner for your organisation.

3. Do's and don'ts of working with a regulatory expert.

4. What makes a long term, successful and efficient relationship.

5. Aligning regulatory strategy with clinical trials design and implementation.

6. Aligning regulatory strategy and market entry strategy.

7. When to seek support from a regulatory specialist.

The masterclass will be followed by an optional tour of Jumar Bioincubator. Let us know in the registration form if you're interested in participating.

About

Set to open it's doors in late 2023, Jumar Bioincubator will act as a first home for biotech startups, providing affordable lab and office space, practical support, and community activities to unlock the potential in early scientific discoveries.

Jumar Bioincubator was established by CSL, WEHI and the University of Melbourne. Together, with backing from innovation investor Breakthrough Victoria and operator Cicada Innovations, the mission is to connect early-stage and scaling biotech ventures with the support they need to progress discoveries towards real-world treatments and therapies and build a critical mass of scientists with the knowledge and confidence to run successful biomedical ventures.