Sydney Professional Certificate

Commercialisation of Pharmaceuticals and Medical Devices

Graduates of this Professional Certificate will have specialised knowledge in the commercialisation of pharmaceuticals and medical devices.

Graduates will be able to :

  • Explain the processes and path for taking a new therapeutic or medical device from conception through to registration
  • Discuss the importance of market analysis and research and associated business skills and asset management frameworks required for each stage
  • Compare the processes and steps required by the local regulatory environment during discovery, manufacture, clinical trial and registration with the requirements of global regulatory systems
  • Appraise the importance of Target Product Profile (TPP) in setting the clinical and regulatory strategies in the Pharma and MedTech sectors.
  • Explain concepts of opportunity recognition, entering new markets, disruptive innovation, venture capital funding and corporate spin-off in the pharmaceutical and medical technology sectors.

 
 

Unit of study Credit points A: Assumed knowledge P: Prerequisites C: Corequisites N: Prohibition Session

Sydney Professional Certificate in Commercialisation of Pharmaceuticals and Medical Devices

Students must complete:
(a) 12 credit points of 5000-level units of study
PCOL5101
Drugs and Devices: R and D to Registration
6      Semester 1
PCOL5105
Commercialising MedTech and Pharma
6      Semester 2

Sydney Professional Certificate in Commercialisation of Pharmaceuticals and Medical Devices

Students must complete:
(a) 12 credit points of 5000-level units of study
PCOL5101 Drugs and Devices: R and D to Registration

Credit points: 6 Teacher/Coordinator: Dr Hui Xin Ong & Dr Rania Salama Session: Semester 1 Classes: online lectures, podcasts, discussion boards, webinars Assessment: online quizzes (20%), short answer questions (20%) written assignments (30%), presentation (15%); case study (15%) Mode of delivery: Online
This unit of study provides a broad overview of the processes involved in translating a new drug, formulation and/or medical device from a laboratory setting to an approved product. It is targeted at people interested in or already working in the pharmaceutical or medical device industries, and advisors in the regulatory sector. Three core areas are covered: (1) the regulatory organisation, (2) requirements during drug discovery and device conception, manufacture and clinical trials, and (3) post-registration pharmacovigilance and pharmacoeconomics . Students will gain knowledge of the Therapeutic Goods Administration (TGA) and guidelines for the registration and regulation of medical devices and medicines. Students will also learn the importance of international regulations, harmonisation and application to the Australian market. The unit covers R and D; manufacturing and clinical trial requirements; the concepts of good laboratory and manufacturing practices (GMP, GLP) and quality by design (QbD); as well as regulator accepted laboratory methodologies used for submission of product dossiers and medical device documentation. The basics of clinical trial design will be analysed, as well as concepts of pharmacokinetics, dynamics, pharmacoeconomics and clinical endpoints for registration of new products using case studies and online tutorials. Special requirements for the registration and testing of generic medicines will also be part of the unit.
Textbooks
online readings and other learning resources will be provided.
PCOL5105 Commercialising MedTech and Pharma

Credit points: 6 Teacher/Coordinator: Dr Rania Salama and Dr Hui Xin Ong Session: Semester 2 Classes: online lectures, podcasts, discussion boards, webinars, interactive media Assessment: online quizzes (20%), short answer questions/case studies (40%), written assignment(s) (40%) Mode of delivery: Online
This unit provides key business skills and related knowledge essential for the commercialisation of products in the medical device and pharmaceuticals sectors; from start-ups to large Pharma. The unit will provide students with a grounding in finance, human resources, market research and analysis, project management, risk management frameworks, regulatory and clinical strategy, freedom to operate and intellectual property. Students will learn how to develop a business case, based on market analysis, understand the process of capital fund raising and construct a development pathway for manufacturing and marketing of both medical devices and pharmaceutical products.
Textbooks
Online resources, readings and other learning recourses will be provided or accessible via the Library