Global Ethical & Regulatory Innovation (GERI)

Initial planning for GERI began in late 2012 with ACRES’ strategic Ally, the Centre for Innovation in Regulatory Science (CIRS) co-leading the Project Steering Committee and a core of collaborating non-profit organizations. The agenda is integrated with other Foundation Initiatives to maximize synergy.

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:

  1. Interactions between regulators and other key stakeholders – in the clinical development phase initially; other lifecycle phases will be addressed later on.
  2. 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.
  3. Support for the global implementation of innovative solutions and high standards aiming for optimal efficiency, including methodologies and systems.

To achieve both innovation and simplification simultaneously, Ethics and Regulatory Innovation Consultations are being convened to map multiple global efforts of regulatory simplification and innovation into a coherent ecology of implementable solutions with ethical review as one point of entry to achieve optimum efficiency in global clinical development. Initial Consultations are planned in the EU in early 2015.

As with the SASI Global Stakeholders Consultations, these will be followed by creation of four implementation-focused working groups. The Innovation Working Groups will be charged with: (1) Mapping of planned and ongoing efforts for enhanced efficiency and innovation; (2) Determination of the need for improvement; and (3) Proposals for innovative approaches, i.e., globe spanning projects to implement increased efficiency.

The four Working groups will focus on:

  • How to meet Ethical and Regulatory needs for the establishment of globally accredited or certified 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.

Appraisal of Working Group results and recommendations for actions and prioritization will include:

  • How to best manage current Regulatory and Ethical requirements, and opportunities for the global implementation of methodologies, systems/tools and processes;
  • How to optimize communication and cooperation among stakeholders; and,
  • How to achieve an optimal future environment for supporting efficient clinical development work, with consideration of overlapping concerns of Ethics, Legal and Regulatory bodies.

Based on these appraisals, a multi-stakeholder panel will prioritize proposals and initiate activities supporting the top priority actions. Implementation of 1-2 Regulatory Simplification/Innovation projects as validated by Consultations is targeted for no later than 4Q 2015.

In preparation for these consultations and to establish effective lines of communication, delegations from ACRES are meeting with national and regional regulatory authorities to inform them and gain support for ACRES vision and mission, including the EMA, PDMA (Japan), FDA, HRA (Singapore).