Dear Colleague,

IITaV invites you and your Partner for an interesting talk on “Regulation of Therapeutic Goods in Australia” with special emphasis on Vaccines and Medical Devices, by Dr. Mandvi Bharadwaj,  on Thursday, 20th February 2020 at Swinburne University of Technology.

The Therapeutic Goods Administration (TGA) is Australia’s regulatory authority for therapeutic goods including prescription medicines, vaccines, complementary and over-the-counter medicines, medical devices, cell and tissue products, blood and blood products. These products are regulated by the TGA in accordance with the provisions of the Therapeutic Goods Act 1989 (the Act). The Act requires that therapeutic products imported into, supplied in, or exported from Australia are included in the Australian Register of Therapeutic Goods (ARTG). The TGA uses a risk-based regulatory process based on the evidence of risk compared to the benefits of the therapeutic good. The regulatory process is based on a two-pronged approach, including premarket assessment and post-market- monitoring and compliance. The presentation will give an overview of the regulatory process with a special focus on medical devices and vaccines.

Details:
Time:   5.30pm for a 6pm Start on Thursday, 20th February 2020.
Venue:  Room AGSE108, Ground Floor, Australian Graduate School of Entrepreneurship (AGSE) Building, Swinburne University of Technology, 50 Wakefield Street, Hawthorn 
Registration: https://www.trybooking.com/BICWU
Contact: Meenakshi Arora (040 191 4420) or Sarbjit Giddey (042 234 1379)

Brief Bio:

Mandvi Bharadwaj is the Director of Biomedicines and Influenza Vaccines Section at the Therapeutic Goods Administration (TGA), Department of Health Australia and holds an honorary position as an Associate Professor at the Faculty of Medicine, University of Melbourne. Mandvi has an Honours, Masters and PhD degree in life sciences complemented by a Masters in Health and Medical Law from the University of Melbourne. Mandvi has over 25 years of experience in scientific research and teaching, gained at the University of Melbourne, Queensland Institute of Medical Research, Westmead Hospital, All India Institute of Medical Sciences and King George’s Medical College and over 8 years of regulatory experience at the TGA. Currently, Mandvi also acts as one of nine advisors within the World Health Organisation advisory group that issues annual recommendations on the composition of the influenza vaccines used worldwide.

Look forward to see you at the event.

IITaV Management Committee