Track Update Track #: 1 Clinical Trials Track
Author : faustina-dinatale | Published Date : 2025-06-20
Description: Track Update Track 1 Clinical Trials Track Learning Objectives Identify current issues and challenges in clinical trial management and execution Reduce clinical trial costs by using innovate practices and technologies Ensure ethical
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Transcript:Track Update Track #: 1 Clinical Trials Track:
Track Update Track #: 1 Clinical Trials Track Learning Objectives: Identify current issues and challenges in clinical trial management and execution Reduce clinical trial costs by using innovate practices and technologies Ensure ethical treatment of clinical trial participants globally Targeted Audience Clinical operation staff Investigator site personnel CROs Budget managers Track Learning Objective and Targeted Audience Drug Information Association www.diahome.org 2 Development of cost effective site budgets Patient enrollment including use of social media Protocol design optimization Approaches to risk based monitoring Supply chain management Ethical consideration in clinical studies Special populations Global study execution (emerging markets) Disruptive innovation to clinical study execution (Pfizer study) What is the focus and flow of this track for 2012? Drug Information Association www.diahome.org 3 28 total Sessions 3 workshops (Metrics, Risk-based monitoring and Investigator site management) 10 symposia 11 sessions 4 forums 1 poster Provide additional details of planned content Drug Information Association www.diahome.org 4 TMF (Track 7) Protocol Design (Track 2) Impact of outsourcing in clinical trial execution (governance, quality) FDA site inspections (Track 11) Possible topics for collaboration with other Tracks Drug Information Association www.diahome.org 5 Managing clinical studies during mergers and acquisitions Partnership (CRO/Sponsor) governance impact on study execution/project teams Where are the gaps? If any? Drug Information Association www.diahome.org 6 Study subjects Patient advocacy group Other industries Potential speakers to invite Drug Information Association www.diahome.org 7 Track Update Track 2: Project/Portfolio Management and Strategic Planning Track Learning Objective and Targeted Audience Project Management Discuss product development/project management practices and budget/forecasting/financing practices used in the industry Identify PM practices, systems, and current trends used in global product development Portfolio Management Identify product development portfolio management practices and portfolio assess strategy decision making methods and tools Discuss portfolio asset strategy decision making, management, portfolio/product prioritization and optimization practices Strategic Planning Describe quality design of clinical trials, complexity of study development, and building quality risk management in clinical trials Identify project and portfolio management practices for strategic planning Targeted audience: Project Managers, Project Leaders, Portfolio Managers Clinical Development Leaders Finance Drug Information Association www.diahome.org 9 What is the focus and flow of this track for 2012? Stay with hot topics for protocol and project-level topics: PM skills and techniques Protocol design topics Bring more focus to program- and portfolio-level topics: Program-level strategic planning Portfolio Management topics Drug Information Association www.diahome.org 10 Provide additional details of planned content Drug Information Association www.diahome.org 11
