Clinical Research Project/Program Management 2019

Clinical Research Project/Program Management 2019 is organized by Society of Clinical Research Associates (SOCRA), Inc. and will be held from Mar 28 - 29, 2019 at Wyndham Garden Lake Buena Vista Disney Springs Resort Area, Lake Buena Vista, Florida, United States of America. This CME Conference has been approved for a maximum of 14.25 AMA PRA Category 1 Credit(s)™.

Conference Description :
Goal: Clinical trial project and program management incorporate a broad range of skill sets in order to plan, administer, track, evaluate and report the activities and budgets involved in the healthcare product development process. The goal of this program is to introduce, affirm or enhance the participant’s understanding of the project management endeavor.

Course Objectives :
Through discussion, presentation, and interaction, this program will broaden the participants’ knowledge of the regulatory framework, project management art and science, planning and accounting, and their attitude and aptitude for achieving successful clinical trials.

Learning Objectives :
• Describe project management and basic risk management principles following PMI (Project Management Institute) guidelines (initiation, planning, execution, monitoring, controlling, and closing).
• Discuss the processes and procedures that are necessary to develop an infrastructure that will support the various tasks associated with Project Management in Clinical Research.
• Discuss how to incorporate IRB interaction activities into a project plan, focusing on issues involved in managing multiple investigational sites. Disaster recovery and contingency planning will be discussed.
• Discuss Organizational Dynamics and psychological issues in project management to promote effective team building. Describe conflict resolution strategies; discuss approaches to work effectively with different leadership and personality styles.
• Describe general start up issues including; budget development, cash flow issues and solutions, billing to CMS (Centers for Medicare & Medicaid Services), and contract management.
• Describe contract development topic issues including: intellectual property (IP) rights, publication, indemnification, payment schedule management, clinical trial sponsor interactions and negotiations.
• Describe various international regulatory bodies and their submission processes using the US Code of Federal Regulations (FDA/OHRP) as a baseline.
• Describe Project Management of the IND and IDE, review guidance documents, forms and accountability measures designated for use by industry and academic research sponsors and sponsor investigators.
• Discuss pharmacy issues related to risk management, safety, drug accountability, drug purity, randomization, blinding and unblinding, inventory control drug & device administration, dose calibration and dose escalation schedules.

Additional details will be posted as soon as they are available.