Global Ethical & Regulatory Innovation (GERI)
GERI supports ACRES’ objective of developing globally implementable solutions within a systems framework for clinical trials, including regulatory innovation to enhance efficiency while maintaining quality and transparency.
Current challenges include: lack of effective and efficient ethical and regulatory standardization globally; complexity of complying with regulations and guidance; and the challenge of regulatory innovation to keep up with biomedical R&D innovation.
GERI is focusing on three key elements of the ethical and regulatory review and oversight processes:
- Interactions between regulators and other key stakeholders – in the clinical development phase initially; other lifecycle phases will be addressed later on.
- Communication and cooperation among stakeholders to increase trust, promoting cooperative and collaborative communication in a transparent manner among key stakeholders in the development of healthcare products.
- Support for the global implementation of innovative solutions and high standards aiming for optimal efficiency, including methodologies and systems.
Working groups will focus on:
- How to meet Ethical and Regulatory needs for the establishment of globally accredited clinical research sites.
- How to achieve global acceptance – in the areas of Ethics and Regulation – of new methodologies and systems to detect, measure, evaluate, and manage risk and harm in clinical trials.
- How to optimize transparency and increase trust in the communication and cooperation among stakeholders.
- How to make the review and approval processes of Ethics Bodies more efficient and mutually acceptable across countries and regions.
ACRES representatives are meeting with national and regional regulatory authorities, including EMA (Europe), FDA (USA), PMDA (Japan), HRA (Singapore) and MHRA (UK), to inform them, strengthening support for ACRES vision and mission.