The Future of Biosafety Testing in Asia
BioReliance® Services Singapore Opening - Technical Seminar
18th September 2018 in Singapore
Join us at our new Singapore facility for an insightful seminar and roundtable discussion lead by industry thought leaders, Dr. Martin Wisher and Michael Payne. They will discuss regulatory issues and risk reduction strategies at this inaugural event. Space is limited for this exclusive event, so register today. Free.
|10.40 – 11.30|
Quality Control of Biological Medicinal Products - Developments in regulatory expectations and technical performance affecting companies in Asia
| ||Martin Wisher, Ph.D.|
- The effect recent regulatory changes will have on CMC (chemistry, manufacturing, and control) aspects of biological products.
- Newly introduced technologies, their acceptance, and the impact on the industry to deliver quicker, wider, and more accurate detection of adventitious viruses and process contaminants.
|11.30 – 12.20||Helping Ensure Patient Safety through Risk Reduction, Biosafety Testing and Compliance|
| ||Michael Payne|
- Comprehensive safety testing program and formal risk assessments are critical to biopharmaceutical manufacturing to ensure patient safety
- Global regulatory and industry guidelines provide basic framework and structure to assist in patient safety and risk reduction
- Step wise mapping can assist in a consistent approach to biosafety assessment, mitigation and testing for “end-to-end” patient protection that covers phase 1 - 5 clinical testing, and for starting material generation to final fill process steps
|12.20 – 12.45||Roundtable Discussion|
|12.45 – 12.55||Closing Remarks|
|14.30 – 15.00||Registration|
|15.00 – 18.00||Opening Ceremony|
| ||(Seminar attendees and invited guests)|
Martin Wisher, Ph.D.
2 Science Park Drive
Ascent Building, Tower B, Level 04