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1/08/2008
Issue Number: 126
In past Newsletters I have talked to you about the great improvements being made in 2008 in ARCS’ three key platforms for Members: Education Information Networking Whether you are an Observer, a Participant, a Contributor or a Leader of ARCS’ activities, make sure YOU take full advantage of the new opportunities available. The new website is about YOU – YOUR choices and YOUR profile drive what you see, with the key inputs being YOUR Interest Areas and Location.
This research project was set up to provide an independent and robust method of collecting the views of a broad cross section of ARCS members (with a focus on the two biggest areas of clinical research and regulatory affairs) to assist the ARCS Board when charting the direction for the Association with regards to a skills and training recognition process.
Proposed amendments to the National Health Act 1953 were introduced shortly after the May budget. These amendments provide a mechanism for the recovery of fees from pharmaceutical companies applying for the listing of new drugs, or changes to existing listings, on the Pharmaceutical Benefi ts Scheme (“PBS”) or designation of vaccines for the National Immunisation Program (“NIP”). Although the amendments were intended to take effect from 1 July 2008, concerns about the impact of the changes have prompted a Senate inquiry. In this edition, we provide ARCS members with an overview of the proposed amendments and some of the issues that have been raised as a result. In a subsequent edition, we will provide members with a full analysis of the outcome of the inquiry.
ARCS and CDISC (Clinical Data Interchange Standards Consortium) share common goals and aims for medical research. We want to educate our members to understand why we are passionate about standards, we work to share our information among our members, taking our message around the globe and we have key alliances with other organisations working in the medical research space. CDISC is a global, open, multidisciplinary, non-profi t organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata.
The 3rd Pharmaceuticals Industry Council (PIC) Research &Development Taskforce (RDTF) Forum – “Clinical R&D in Australia: Innovation and Global Competitiveness” was held in Sydney on 2-3 April 2008. The Forum was sponsored by the Australian Department of Innovation, Industry, Science and Research (DIISR) and meeting logistics supplied by ARCS Australia Ltd. The PIC is a peak industry body with membership and support from AusBiotech, Generic Medicines Industry Association and Medicines Australia. The goal of the PIC is to ensure the growth and development of Australia’s pharmaceuticals industry. DIISR is also represented on PIC. The full Forum report and all presentations are available on www.pharmacouncil.com.au on the “Resources” tab. The focus of this fi rst report is on the changes introduced during 2007 and the survey of Forum participants concerning Australia’s global competitiveness.
This informative session was organised by the Medical Information ESC and chaired by Robyn Stone from Roche. Four speakers with backgrounds in clinical research and quality, information management and law provided valuable insight into the challenges that face the pharmaceutical industry in managing information.
The main objective was to explore these two unique therapy areas to give a greater insight into whether monitors would like to pursue careers monitoring in specialty areas.