APEC RHSC CoE Pilot Workshop - Biotherapeutics and Biosimilars

  • 29 October, 2018 to 30 October, 2018
  • 9:00am - 6:00pm

REGISTRATION IS CLOSED. THANK YOU FOR YOUR SUPPORT.
Biotherapeutics, or medicinal products manufactured using living cells or tissues, are the trending developments from leading pharmaceuticals in the treatment of conditions related to oncology and immunology among others. The exponential progression in science and medical practices necessitates all involved or interested in this field to keep current with the developments. In particular, the increasing production of biosimilars, or generics of biotherapeutics, demands the attention of regulatory professionals. In the context of the complex scientific knowledge and the evolving understanding of good practices in regulating these products, this APEC Regulatory Harmonisation Steering Committee pilot Workshop, in conjunction with the APEC Harmonisation Centre, aims to provide the necessary foundations in understanding the regulatory controls for these innovations, including aspects of quality, non-clinical and clinical considerations.

Biotherapeutics and Biosimilars Course

  • 29 October, 2018 to 2 November, 2018
  • 9:00am - 6:00pm

REGISTRATION IS CLOSED. THANK YOU FOR YOUR SUPPORT.


The advent of biotherapeutics and biosimilars highlighted the need for regulatory affairs to accommodate the rapidly evolving medical sciences, necessitating timely revisions in policies, processes and the technical knowledge in managing these new innovations and facilitating access to meet medical needs. This four-credit module provides the background to the rise of these biologicals in healthcare, and the defining differences from traditional pharmaceuticals and generics. There is a focus on post-market activities which serve as the main guards for ensuring the safe use of these products. Click here to register for the GMS5104:Biotherapeutics and Biosimilars Course as a participant.

2018 Digital Health Forum

  • 20 November 2018

The NIHA Digital Health Forum will bring together key thought leaders from the medical-technology industry and various government agencies to discuss the current digital healthcare landscape in Asia-Pacific. Providing a neutral platform for healthcare professionals, regulators, industry and innovators, this forum will discuss issues surrounding healthcare innovation within the region. This event will be of interest to professionals from medical-device enterprises, healthcare service sectors, and members from both regulatory and government institutions.