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ARCS offers members of NZACRes to join ARCS at a discounted rate

The ARCS Board has moved to better define the membership categories, and Full Membership will be only available to those based in Australia and working primarily in or for the industry in therapeutic development roles. ARCS have established a new Class of membership called Overseas Associates to encourage membership from all the various countries with an interest in the Australian research environment and ARCS services. Their goal is to be able to meet the needs of this group more effectively in the future through e-learning and the development of co-operative agreements with organizations in their country.

To this end ARCS have agreed to allow members of NZACRes to join ARCS at a discounted rate of $95 AUD. As a special Overseas Associate Member of ARCS,NZACRes members will be eligible for all member benefits (member-only areas of the website, information services, discounted attendance at ARCS events etc), including the DIA e-membership. The new ARCS Constitution will apply to applications and renewals and at renewal members will be asked to confirm their status and any change will only be implemented then. Click here to download the application form and apply today!

Australian and New Zealand Melanoma Trials Group (ANZMTG)

ANZMTG is an independent group was established in 1999 and strives:

  • To bring together researchers, clinicians, health care professionals and consumers with an interest in melanoma clinical trials to foster collaboration and the exchange of ideas.
  • To develop and support large-scale, multi-centre melanoma studies of clinical relevance and importance which would be difficult for any single centre to complete.
  • To provide a single point of contact for sponsors and investigators wishing to undertake melanoma trials in Australia and New Zealand.

ANZMTG membership is free and open to all researchers, industry representatives and consumers.

The group is growing at a rapid pace and are about to publish their first newsletter (which will provide a good update of recent activities).

The ANZMTG clinical trial portfolio currently includes 4 active studies and 3 proposed protocols. More study specific information is available on their website: www.anzmtg.org

ANZMTG also encourages new research and is able to facilitate new protocol development. A study synopsis application form will be posted online soon. 

Application forms are available online and also attached please find a membership form.

Australian & New Zealand Clinical Trials & Research Providers Directory to facilitate access to Australian and New Zealand service providers engaged in Pharma, Biotech and Device Development.

The Directory will:

  • provide a reference tool for companies within Australia and New Zealand to access development sites and services
  • facilitate access for international companies to Australia and New Zealand service providers
  • provide a resource to trade development agencies to promote Australian and New Zealand capabilities
  • create greater transparency of Australian and New Zealand development capabilities
  • improve the efficiency of Australian Pharma, Biotech and Device Development.

The Clinical Trials & Research Providers Directory is a joint initiative by the Australia - New Zealand Biotechnology Alliance (ANZBA), Invest Australia and New Zealand Trade & Enterprise. Coordination and compilation of data is being managed by ANZBA.

More information www.biotechalliance.org/clinicaltrials

Consultation Documents:

How should high cost medicines be funded? Public consultation, December 2006
PHARMAC is now seeking public submissions, due by Monday 5 March 2007
http://www.pharmac.govt.nz/highcostmeds.asp

Towards a New Zealand Medicines Strategy Consultation Document - PHARMAC consultation document.
http://www.moh.govt.nz/moh.nsf/pagesmh/5633/$file/towards-newzealand-medicines-strategy-consult.doc

ACART (Advisory Committee on Assisted Reproductive Technology) - Submissions on Human Gamete and Embryo Research.
http://www.newhealth.govt.nz/acart/

NEAC (National Ethics Advisory Committee)Ethical Guidelines for Observational Studies: Observation Research, Audits and Related Activities:
http://www.newhealth.govt.nz/neac/

NZACRes establishes communication channel with Multi-regional Ethics Committee 

In June the NZACRes committee had the great opportunity to meet with members of the Multi-regional Ethics Committee (MEC) and the Northern X and Y committees in Auckland - to discuss some questions on the new multi-regional Ethics process and learn more about the committees` work. It was an open and constructive exchange and NZACRes could establish a channel of communication between the Ethics committee and members of the research community.

The MEC made the following recommendations how researchers can assist the ethical review process:

  • Applications should be complete in all applicable parts attached and declarations signed. Incomplete applications, unclear or missing information can cause delays in the review process.
  • Applications are circulated to MREC members as paper copies. To help the administrative process, applications should be collated when submitted: The subject information sheet, consent form and any other papers to go tho all committee members should be included behind each application copy.  Submissions should be sent in one batch and application should conform to the published guidelines.
  • Subject information sheet and consent form should be clearly written in lay language. 
  • The principle investigator attending the meeting can answer in depth questions about the application.

Furthermore, some areas for training were identified and the NZACRes committee is looking at adequate training sources for researchers  which can help to improve the quality of research applications. This will focus on two key aspects:

  • Provide a well-written and complete application as per guidelines;
  • Design of a sound research project using appropriate methodology.

Following this meeting, a Safety Discussion Group formed to look at possible improvements of the safety reporting process. We were also informed that NEAC (the National Ethics Advisory Committee) is looking at the possibility of expedited review for low-risk observational studies; this is currently worked through by the ministry of Health. A review of the application forms will be carried out, and this will include the feasibility of electronic submissions

The Multi-Regional Ethics Committee informs: Amendments to documents

To facilitate timely review of amended documents by the MREC, the chair asks that the following should be considered by the applicant:

  • When you submit an amended Participant Information Sheet and/or Consent Form, please have the changes be either tracked or highlighted on the documents themselves.  A brief description in your covering letter is helpful, but the Chair is finding that he is spending lengthy amounts of time identifying where the changes have taken place.
  • To facilitate the review process of amendments, please do from now on 
    a) list  the changes on the covering letter and
    b) highlight/track  the changes  in the documents themselves
     
  •  Please ensure that  every piece of correspondence  is submitted with a cover letter which includes both the study title and Ethics Reference number, including the three letters at the beginning (ie CTY/06/06/066). 

    It would be most appreciated by the MREC administrators if you would pass on this information to anyone else you think this is relevant.

The Royal Society of New Zealand maintains a list of all science and technology awards available to New Zealanders. The list is at www.rsnz.org/awards/other.php