The papers that have been accepted for the conference have been grouped into more traditional conference sections, in order to help the conference committee assemble an appealing program. Here are the conference sections that have been formed:
- Advanced Programming: Explanations of sophisticated programming techniques, examples of solving specific programming problems, and other innovative, high-level technical presentations geared for an audience of intermediate and advanced industry programmers.
- Applications Development: The development and use of programs, systems, utilities, and productivity tools designed to assist us in doing more in our daily jobs, plus an overview of the code and software development techniques used in the process.
- Data Standards: Discussion of industry data standards such as CDISC SDTM and ADaM, data exchange with partners and vendors, data management, controlled terminology, versioning, data quality, implementation strategies, pilots and case studies for drug, biologic, medical device and diagnostic regulatory submissions.
- Leadership and Career Development: Discussion of issues facing programmers, consultants, executives and front-line supervisors in today's pharmaceutical and biotech industries including career advancement, soft skills, interpersonal interactions, leadership development, mentoring, directing teams, recruiting and retention, consulting and contracting, networking techniques, or other relevant subjects.
- Programming Techniques: Explanations of fundamental programming techniques, tutorials, examples of using programs to solve specific problems, and other technical presentations geared for an audience of beginner and intermediate industry programmers.
- Real World Evidence: Discussions regarding the use of software tools, analytics, and data mining in healthcare research areas that focus on patient-reported outcomes, registries, risk evaluation and mitigation strategies, knowledge and behavior surveys, call center metrics, health claims, and other post-submission assessments and post-marketing sources.
- Reporting and Data Visualization: Material pertaining to techniques for creation of reports and graphs, methods and tools for data visualization, and the practical application of new technology to effectively communicate data and analytical results to key stakeholders, medical personnel, regulatory authorities, and the general public.
- Statistics and Analytics: Topics dealing with implementation of statistical methods and advanced analytics to report results from all phases of clinical trials, public health studies, and healthcare research.
- Strategic Implementation, Business Administration, and Support Resources: Content dealing with business operations such as managing complex clinical trial programs, deploying new technologies, programming metrics, temporary workforce challenges, training methods and programs, and effective use of support resources such as technical support, discussion forums, user groups, and social networking sites.
- Submission Standards: Discussion of global submission industry standards, best practices and implementation strategies for deliverables such as define.xml, SDRG, ADRG and eCTD folder content, the use of metadata repositories and other tools to automate submission documentation, submission experiences, pilots and case studies for drug, biologic, medical device and diagnostic regulatory submissions.
- Hands-On Training: Interactive training on a variety of topics that provides attendees with practical “hands-on” experience using industry software tools in a classroom setting equipped with computers and under the skillful guidance of seasoned experts. Invited Speakers only.