THE ROLE OF A SPONSOR WORKSHOP

Training and Workshops

COURSE STRUCTURE

The workshop consists of real-world case scenarios, supported by a series of checklists and flow charts based on the requirements of the Australian legislation and Medical Device Regulations.

Training and Workshops

AIM

To provide competence in understanding the role of a sponsor and ensuring that the TGA sponsor is well prepared.

TOPICS COVERED

  • Demonstrating that the correct procedures are in place with the manufacturer;
  • Types of documents required to demonstrate compliance with the Essential Principles;
  • Making declarations under Section 41FD of the Act;
  • Responding to requests from the TGA issued under Section 41JA and 41 GN of the Act;
  • Notifying the TGA of incidents and performance issues; and
  • Successful lodgment of device applications.

DURATION: HALF DAY