Home>Events>Merck Seminar, Singapore, 18th September 2018

The Future of Biosafety Testing in Asia

Merck Seminar, Singapore, 18th September 2018

MilliporeSigma Vibrant M

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.

Agenda

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 – 12.20Helping 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 – 12.45Roundtable Discussion
 
12.45 – 12.55Closing Remarks
 
13.00Lunch
 
14.30 – 15.00Registration
 
15.00 – 18.00Opening Ceremony
 (Seminar attendees and invited guests)
 
Our Industry Thought Leaders
Martin Wisher

Martin Wisher, Ph.D.

Global Head of Regulatory Affairs, BioReliance
Merck, KGaA, Darmstadt, Germany

With more than 30 years of experience in biologics quality control, assay and process validation, Dr. Wisher is well regarded in the biopharmaceutical, vaccine, gene and cell therapy industries. He has written numerous quality and regulatory articles and conducted biologics safety testing workshops and seminars around the world.

Dr. Wisher is currently Vice-Chairman of the Animal Cell Technology Industrial Platform (ACTIP) and has been a Chairman of the PDA Virus Spike Quality working group and a member of WHO and PDA working groups. He has held regulatory leadership positions in BioReliance®, recently acquired by Merck KGaA, Darmstadt, Germany, since 1990. He obtained his PhD in membrane biochemistry from the National Institute for Medical Research in London and subsequent further research on membrane receptors, monoclonal antibodies, and recombinant vaccines.

Michael Payne

Michael Payne

Michael Payne is the senior technical management biosafety consultant in Asia.

He has worked in the pharmaceutical and biopharmaceutical industries for more than 30 years including 10 years in the U.S. as the head of global technical training. Michael is responsible for supporting compliance and best.

Venue Information

Merck
2 Science Park Drive
Ascent Building, Tower B, Level 04
Singapore 118222