ASA Biopharm Safety Working Group (SWG)
Vision
To establish the Safety Working Group (SWG) as a leading force in advancing interdisciplinary safety sciences, fostering innovation, collaboration, and education to improve drug safety and benefit-risk assessments globally.
Mission
To foster collaboration among academia, industry, and regulatory bodies, integrating expertise from statistics, epidemiology, and clinical science to advance innovation with respect to safety methodology, planning, signal detection and profiling, risk management, and benefit-risk evaluation throughout the drug development lifecycle. Education and tool development are core to our mission to help facilitate informed decision-making and impactful outcomes.
Governing Principles
- Encourage active partnerships between statisticians, epidemiologists, clinicians, and other experts across academia, industry, and regulatory sectors.
- Develop and promote novel methodologies and practical solutions that address real-world challenges in safety evaluation, with a focus on translating concepts into implementable tools and workflows that are feasible, and relevant to regulatory and industry practices.
- Provide accessible educational resources and training to ensure stakeholders understand and apply safety sciences effectively.
- Regularly assess and refine task forces and initiatives to align with evolving scientific, regulatory, and industry needs, ensuring long-term relevance and effectiveness.
- Uphold the highest standards of scientific integrity, ensuring that all work serves the public good to inform benefit-risk evaluation and support decision making throughout the drug development lifecycle.
Workstreams
The SWG consists of three workstreams (WS), which are general scope and relatively long-term.
Each workstream includes several task forces (TF), which are deliverable-based and time-bounded.
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