Event date: 11–12 October & 18–20 October 2021
Better regulatory, clinical and access skills for entrepreneurs, academics, and clinicians
A 5-day program for Australian MTP start-ups and SMEs developing medicines.
This program will provide practical education on incorporating regulatory and reimbursement needs for both domestic and international markets into the development plans to facilitate potential earlier market access of medical devices. The program provides access to a faculty of skilled and experienced trainers and practitioners.
The bootcamps are offered as in person events. Registration fee is $500 (excl GST). Some preparatory course work may be required.
This course prepares you to understand the factors that impact design of clinical trials and evidence generation plans to meet the requirements of regulators and payors requirements. It is for people developing products which are therapeutic goods.
Day 1 (11/10/21): Drug development: From bench to bedside
It is critical to start development with the end in mind. The Target Product Profile (TPP) is the intended profile of a pharmaceutical/biotechnology product or technology, developed based on cross-functional discussions. Once the TPP is finalised, the drug development plan is developed which includes the clinical research strategy (including critical information regarding design, study endpoints, study design). It also forms the basis of the regulatory documentation package.
Day 2 (12/10/21): The Regulatory Landscape
Market authorisation (and reimbursement) requirements in each country drive the quality, safety and efficacy evidence that must be generated as well as overall regulatory strategy. It is critical to understand the benefit:risk balance of your product under development so that critical go:no go decisions can be made at each transition stage in the development process. The global regulatory strategy is increasingly determined by new harmonisation initiatives between national regulatory authorities and understanding these initiatives can speed up access to a number of global markets.
Day 3 (18/10/21): Health Technology Assessment (HTA) considerations
Health technology assessment (HTA) used by developed countries differs in the type of clinical data needed and goes beyond the requirements for market authorisation, thus creating an additional evidence gap between the regulatory and the reimbursement submission. Increasingly, HTA requirements are incorporated into trial design in order to prepare for market access. This session will provide an introduction to HTA approaches and the evolving international landscape, focusing on what this means practically for course participants designing trials at their stage of product development.
Day 4 (19/10/21): Clinical development planning and implementation
As the TPP evolves, clinical development is planned to meet the specified criteria. This session will be a very practical, hands-on session with a particular focus on clinical trial standards, processes and conduct.
Day 5 (20/10/21): Trial design fundaments & pulling it all together
This session will be a very practical, hands-on session with a particular focus on the application of statistical concepts.