CNS initiated the first national, privately owned, commercial IBC in Australia, successfully accredited by the Australian Office of the Gene Technology Regulatory (OGTR).

Having access to an Institutional Biosafety Committee (IBC) is a prerequisite for an organisation to obtain and maintain accreditation for the conduct of studies using investigational products that are genetically modified organisms (GMOs) in Australia. All necessary license and notification applications require review from an IBC before successful applications can be submitted to the Office of the Gene Technology Regulator (OGTR).  

ABOUT THE IBC

Simone Flight

Dr Simone Flight
Chair

Hiram Chipperfield website

Dr Hiram Chipperfield
Secretary

Caroline Dobbin website

Dr Caroline Dobbin
Microbiologist

Barbara Kienast Headshot

Barbara Kienast
Clinical Operations
Manager

Susanna Mantovani

Dr Susanna Mantovani
Molecular Biologist

Howard Wraight website

Dr Howard Wraight
Medical Doctor

Layne Wright Headshot

Dr Layne Wright
Quality Assurance

 

Suzanne Elliott

Dr Suzanne Elliott
Microbiologist &
Independent Member

Paul Griffin 22Nov17 GIF

Dr Paul Griffin
Medical Doctor/Virologist
& Independent Member

 

 


As an accredited organisation with the OGTR
, CNS' IBC provides GMO classification advice and performs the review and submission of GMO licence applications and notifications to the OGTR. The GMO classification types in Australia include ‘Exempt Dealings’ (GMO products or ‘dealings’ not requiring a GMO licence), Dealings Not Involving Intentional Release (DNIR), Dealings Involving Intentional Release (DIR) licensable GMOs, or Notifiable Low Risk Dealings (NRLDs).

As a full service provider, CNS can act as both the Applicant for the GMO licence and the Sponsor of the clinical trial.  This dual capability allows for the streamlining of Australian sponsorship for clinical trials using GMOs as CNS can be responsible for all monitoring aspects of the study. However, if a company has a legal Australian entity, they can choose to be the applicant and hold the DNIR or DIR license ensuring the conditions of the license are upheld throughout the trial.

CNS will provide ongoing support throughout the evaluation phase of the DNIR or DIR with the OGTR and will respond to questions raised by the OGTR in writing following consultation with our client.

 

To find out how CNS’ fully accredited IBC can assist you, contact us