Speakers’ Corner

ARCS Scientific Congress (ASC)
6 – 7 June 2012
Sydney Convention Centre, Darling Harbour

 CALL FOR ABSTRACTS

In 2012, we return to Darling Harbour for our biggest Congress of the year.

General Guidelines

 The Sydney ARCS Scientific Congress (ASC) Committee encourages the submission of abstracts which are thought provoking and include the sharing of actual case studies to promote information exchange.  Abstracts should reflect contemporary issues and may be controversial and/or cutting edge.

All sessions must adhere to ARCS’ Policy prohibiting explicit promotion of products or services by session speakers or chairs (available from the ARCS Business Office).

• Proposed sessions should have a mix of speakers from a range of organisations and disciplines to provide a range of views on the proposed topic
• Proposed abstracts must be for one of the following:
• A complete 90 minute concurrent information sharing session, or
• A complete 3 hour concurrent workshop session, or
• A 30 minute speaking slot (including Q+A)
• Authors of concurrent information sharing/workshop sessions will be responsible for recruiting additional speakers (a maximum of three speakers for any 90 minute session)
• Chairpersons who contribute significantly to the development of sessions by fulfilling their responsibilities as outlined in the 2012 ASC chairperson toolkit, will be offered:
• An ARCS training voucher to the value of $1000 for themselves or a team member or
• complimentary registration (free of charge), for one or two days of the Congress for themselves or a team member
• All speakers will be offered complimentary registration for the day they are speaking and reimbursement of domestic travel costs, in accordance with ARCS’ Policy. Speakers will also be offered a substantial discount if they nominate to attend the additional day
• Authors who submit topic ideas for a speaking slot (and who are accepted by the Congress Committee) will be scheduled into an appropriate session with other related topics

 

The ARCS Business Office will be the final arbiter of topics, appropriate speakers and complimentary registrations.

• Abstracts must be submitted via the Online Form provided and received at the ARCS Business Office by close of business 30th November 2011
• All speakers need to be identified by the 12th December 2011
• Questions about the Congress should be sent to asc@arcs.com.au
• Abstracts will be included into the program by the Sydney ASC Congress Committee on the basis of content, originality, relevance to the ARCS membership and fit within the general program and these general guidelines
• Abstract authors will be notified in early December regarding the status of their submission

 

The following information is required by the 30^th November:

• Name and contact information of the author(s) (email address and phone number)
• Session title:
• Primary interest area and associated interest areas (to encourage co-operative development):
• Type of abstract:
• Learning objectives (300 words):
• Abstract summary (300 words):

 

Before submitting your abstract you will need to register an account. Once registered, you will be e-mailed a password (Ei access key) which will enable you to add a new abstract as well as make changes to an existing abstract. The system will allow you to submit multiple abstracts.

Abstracts are sought under the following general areas of interest:

Asia Pacific Development

Abstracts relating to challenges facing those working in research and development in the Asia Pacific region, includingChina,JapanandIndiaare welcome. Topics may include challenges associated with conduct of clinical trials, safety reporting, logistics, ethical and cultural differences impacting clinical research as well as the evolving research environment in the region.

Biotechnology and Preclinical/Early Phase Research

Abstracts related to discovery and early development of novel products and novel delivery technologies inAustralia. 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 as well as challenges of setting up, recruiting and monitoring phase 1 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 hospital, research institution and 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, investigator site selection and monitoring requirements, QoL collection of data and outcomes, new technologies for e-trials (including eRecords, eData and eCRF design), along with tactics/processes/tools for efficient execution of clinical trials. Abstracts on the operations, conduct and management of clinical trials e.g., subject recruitment, retention, and management, budget negotiation and management, HREC and governance requirements, training and education for staff, the use of metrics to manage studies and personnel and other topics of interest in clinical research are also welcomed.

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

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.

Medical Devices

Topics relating to the clinical development of medical devices. Abstracts which cover more general topics in the context of Medical Devices may also be submitted. The recently updated EU requirements implicating the orthopedic area would also be welcomed. 

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., customer satisfaction (both internal and external), 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.

Medical Affairs

Abstracts should address topics and issues relating to those working in a medical affairs role including up skilling in therapeutic area knowledge, scientific meeting planning, managing the KOL relationship, creating synergy between marketing and medical affairs, metrics and the medical affairs value proposition, building scientific awareness, initiating and maintaining relationships with healthcare customers, compliance with legal and regulatory guidelines as well as gathering and providing competitive intelligence.  Abstracts which cover more general topics in the context of Medical Affairs may also be submitted.

Health Economics and Outcomes Research

Regulatory Affairs

Abstracts from these disciplines which focus on providing education to those working in research and development would be welcomed while abstracts which focus on technical training or common issues for those working in these areas would be better suited to the ARCS Canberra meeting in September 2012 (call for abstracts to be sent out in early 2012).