ARCS Scientific Congresses 2010
27-28 May 2010 (Sydney) AND
13-14 September 2010 (Canberra)

CALL FOR ABSTRACTS GUIDELINES 

In 2010 there will be two ARCS Scientific Congresses as follows:

  • The ASC Autumn Meeting to be held in Sydney on 27th and 28th May 2010
    This meeting will focus on the development of therapeutic goods in Australia and the Asia Pacific region. You are invited to submit sessions of relevance to scientists in industry, research institutions, government and academia involved in R&D, clinical research, audit and compliance, data management and statistics and related disciplines. 
  • The ASC Spring Meeting to be held in Canberra on 13th and 14th September 2010
    This meeting will focus on partnerships with regulators and reimbursement agencies. You are invited to submit sessions of relevance to those involved with peri-and post-marketing activities for therapeutic goods (prescription and OTC medicines, devices and biologics).

General Guidelines

  • All session abstracts must be for a complete session - individual presentation abstracts will not be considered. See below for types of sessions.
  • The author of the selected abstract will be responsible for recruiting additional speakers from relevant and diverse sources. All speaker details will be required by18th December 2009.
  • All sessions will be assigned a Chairperson from the relevant Education Subcommittee or area of interest. 
  • All speakers are offered complimentary registration for one day of the Congress and reimbursement of domestic travel costs, in accordance with ARCS’ Policy. 
  • All sessions must adhere to ARCS’ Policy prohibiting explicit promotion of products or services by Session speakers or chairs.
  • Abstracts are particularly welcomed which have a mix of speakers from a range of disciplines.
  • Contributors are encouraged to develop abstracts which are thought provoking and include sharing of actual case studies to promote information exchange. Abstracts should reflect contemporary issues and may be controversial and/or cutting edge.
  • Abstracts must be submitted via the Online Formprovided and received at the ARCS Business Office by close of business 20th November 2009.
  • Emails with questions about Congress may be sent to asc@arcs.com.au
  • Abstracts will be selected on the basis of content, originality, relevance to ARCS’ membership and fit with these general guidelines.

The following information will be requested at the time of submission:

  • Name and contact information for author (email address and phone number)
  • Session title
  • Primary interest area and associated interest areas (to encourage co-operative development)
  • Which Congress you are submitting to (see top of this document)
  • Target audience and level of experience
  • Type of session:
    – Plenary – all attendees; 1.5 – 2hr
    – Concurrent; Seminar style; 1.5 hr
    – Concurrent; Workshop style; 1.5 – 2.0hr
    – Concurrent; Workshop style; 4 hours, including a break.
    – Concurrent; Consultation/Forum; 1.5hr
  • Learning objectives (300 words)
  • Abstract summary (300 words)

Speaker Pool

ARCS workshops, symposia and seminars involve hundreds of speakers every year. If you are interested in becoming part of our speaker pool, please click here to register.

Abstracts are sought under the following general areas of interest:

Asia Pacific Development

Abstracts relating to the development of clinical research and the management of regulatory challenges in the Asia Pacific region, including China, Japan and India are welcome. Topics may include challenges associated with conduct of clinical trials, safety reporting, logistics, ethical and regulatory approval, cultural differences impacting clinical research as well as the evolving regulatory environment in the region.

Biotechnology and Preclinical/Early Phase Research (to be managed by Regulatory ESC)

Abstracts related to discovery and early development of novel products and novel delivery technologies in Australia. The sessions may also cover the evaluation of pre-clinical and pharmacokinetic data, the use of biomarkers for efficacy and toxicity and their impact on the initiation of human clinical trials. Discussions may also include enabling translational research from academia and identifying key elements of due diligence exercises for novel products or technologies to expand product pipelines. Management of intellectual property in early phase research would also be welcome.

Business Skills

Sessions covering topics related to increasing efficiency and skills in the many areas of business practice such as presentation skills, effective use of technology, budget management, personnel management and leadership are welcomed. These sessions must be relevant to the anticipated audience of mainly scientists and medical professionals working in the development of therapeutic goods.

Clinical Data Management and Biostatistics

Abstracts in this area should focus on the most current and forward-thinking topics as they relate to the clinical data management function and its future role in the industry. Globalisation of data management, novel approaches, interactions with other functions or topics related to broadening the responsibilities of data management will be welcome. Topics in statistics may include innovative or novel clinical trial designs, sample size considerations, modelling and trial simulation, statistical monitoring/interim analysis of safety and efficacy, statistical methods for analyzing data. Sessions may also cover effective, efficient and quality methodologies for computerized system validation, effective auditing of vendor or investigator computerized systems for compliance, quality and integrity.

Clinical Research

Abstracts are welcome from both industry and investigator groups and should address topics related to clinical trial methodology and implementation, including clinical plan and protocol development, new technologies for e-trials and tactics/processes/tools for efficient execution of clinical trials. The operations, conduct and management of clinical trials at investigative sites, e.g., subject recruitment, retention, and management, budget negotiation and management; HREC requirements; training and education for staff; the use of metrics to manage studies and personnel; and other topics of interest in clinical research.

Clinical Quality Compliance

The topics/issues related to the good clinical practices aspects of both global and local clinical trials, including internal QA programs and audit outcomes, regulatory inspections and discussion of the latest issues in the clinical trial process. Issues such as informed consent and ethics committee procedures, compliance and oversight of clinical trials, use of electronic systems in clinical trials, including validation and audit of these systems, detection and prevention of fraud and misconduct in clinical trials and auditing practices and techniques.

Clinical Supplies and Logistics (Clinical Research, Clinical Quality Compliance ESCs)

Abstracts should address quality initiatives and processes or leading edge technologies used to improve the efficiency and logistics of the clinical supply chain to sites locally and globally. The use of technology to streamline systems of supply and procedures to minimize the traditional overage of supplies needed to conduct clinical trials are of interest. Other topics of interest include the identification, assessment and management of clinical laboratories, both locally and globally, interpretation of trial specific laboratory data and optimal handling of biological samples.

Health Economics and Outcomes Research

This interest area focuses on current issues related to the generation, analysis, and utilization of evidence to assess the impact of medical products on health outcomes. Sessions may focus on issues related to obtaining, measuring, and evaluating evidence, pharmacoeconomics and costeffectiveness, health services research, and pharmacoepidemiology (non-safety related). Data, methods, and case examples may come from a variety of sources and settings, including but not limited to clinical trials, observational or claims databases, surveys, and registries.

Medical Devices

Topics unique to the clinical development, regulatory approval and reimbursement of medical devices are of increasing interest to our members. Abstracts relating to these matters are welcomed and will be managed by the Medical Devices ESC. Abstracts which cover more general topics in the context of Medical Devices may also be submitted, and will be jointly managed with the relevant ESC e.g. Health Economics.

Medical Information

Session abstracts should address topics related to the practice and provision of drug or medical information for internal or external customers including healthcare professional and consumers. Examples of appropriate topics include, but are not limited to, the provision of approved and non-approved information, systems for managing and tracking responses, literature evaluation, innovative technologies, legal and regulatory issues of medical communications and the advertising and promotion of pharmaceuticals.

Medical Writing

The focus in this area should be on updating skills and keeping abreast of changes in the local and global environment as they relate to the preparation and publication of documents required throughout the therapeutics development cycle. Topics may include progress in the electronic environment (including templates and guidelines for electronic submissions) and medical writing in cross-functional teams. Abstracts relating to the challenge of managing documents in the global, electronic environment, and document archiving will be welcome.

Pharmacovigilance

Issues affecting the collection, management, assessment, regulatory reporting (expedited, periodic, special), use, and communication of patient safety data (signs, symptoms, diagnoses, laboratory data) during development and post-approval in Australia and internationally. May relate to new regulatory requirements, new technologies for reporting, coding and tracking events, signal detection, compliance and auditing and risk management.

Project and Workplace Management

Abstracts should address topics and issues related to e.g., planning, scheduling, execution, resource management and risk management within project teams. Also team development, leadership, negotiation and conflict resolution. Topics related to different models for outsourcing of activities in connection with the drug development process are welcome. Presenters are encouraged to include the use of case studies of successes with any of the above topics.

Regulatory Affairs

Session topics may relate to prescription and non-prescription products, including biologicals and new therapies demanding different approaches. They should address changes in the regulatory environment in Australia, as well as issues related to globalization and harmonization. Sessions which involve interaction with the regulatory authority are always welcome. Abstracts may address the practical, everyday issues for regulatory professionals, regulatory process and mechanisms or special regulatory challenges of today or tomorrow. Topics may relate to challenges from all sections of a dossier – Quality, GMP, Preclinical or Clinical, or associated with electronic submission formats, management of global submissions and opportunities for harmonization.