A new Regulatory Roadshow has been designed to help SMEs and early-stage companies understand the 101 regulation when commercialising technologies. The event will help medtech SMEs further their understanding of regulatory pathways, key requirements, and when to start planning.
AusBiotech and its AusMedtech Regulatory Affairs Panel is delivering a lunchtime ‘Regulatory Roadshow’ in Sydney on 3 December, together with Host Partner Dentons and including participation by the TGA.
The lunchtime seminar is the first of a series of events to be held across Australia during 2020. This pilot will focus on medtech regulation, with the programme of events expanding to include biotherapeutics later in 2020. This series is part of a broader set of work AusBiotech is undertaking to support SMEs and early-stage companies.
An understanding of regulatory pathways is critical to successful commercialisation and is recognised as complex.
The workshop will include chances to hear case studies from companies with significant experience, including Brandwood-CKC, Medtronic, Nanosonics and J&J Medical. The TGA will also present on:
- Regulatory frameworks and processes 101 (pre to post market)
- Tips for expediting regulatory approvals
- Most common mistakes (e.g. relating to conformity assessments)
- Emerging technologies
- International regulatory harmonisation: implications of the EU regulation changes
- Opportunities for Q&A with the TGA and AusBiotech’s Regulatory Affairs Expert Panel
This event is free for members and $120 for non-members. Register now.