We are delighted to announce the appointment of Dr. Dean Regier as the Chair for the new Regulatory Advisory Council.
For more information on the appointment and the council, please read here
Terms of Reference – Regulatory Advisory Council (RAC)
Purpose
The purpose of the Academy of Translational Medicine (ATM) RAC is to:
• Provide the leadership of the ATM with a deeper understanding of the current and anticipated regulatory landscape and challenges for efficient, timely and effective translation of medical innovations to the clinic;
• Provide guidance to the ATM membership on strategies to navigate roadblocks to successful regulatory approval, based on the current regulatory environment and anticipated changes;
• Propose to ATM leadership innovative approaches and policy recommendations for creating a regulatory landscape that supports more efficient, timely and effective translation of medical innovations to the clinic, both domestically and globally.
Composition
The ATM RAC is made up of ex-officio and appointed members from the UBC Faculty of Medicine and from local and international industry and academic institutions.
The Faculty of Medicine’s commitment to equitable and diverse membership on its committees and advisory councils guides its nomination and selection process.
Ex-officio
• Dean, Faculty of Medicine
• Vice Dean, Research
• Senior Director, Research
• Director, Academy of Translational Medicine
• Operations Director, Academy of Translational Medicine
Appointed
Eight to ten members from local, national, and/or international academic institutions and/or industry appointed based on relevant expertise (see appendix A for current membership), including one representative from the medical device industry to provide expertise on regulatory affairs for medical devices.
In addition, it would be desirable to have one member from BIOTECanada or Innovative Medicines Canada (IMC) to represent the interests of the Canadian bio-innovation and pharmaceutical industry.
In addition, one member representing patient interests. The member should be knowledgeable about the landscape of regulatory patient advocacy.
In addition, one rotating member representing the Industry Liaison Advisory Council (ILAC): membership will rotate every year, and the ILAC representative will be member of both the RAC and the ILAC for the one-year term.
Guests may be invited to join specific meetings or portions of specific meetings at the chair’s discretion.
Appointment Process
Ex-officio members are members by virtue of their administrative appointment.
Appointed members are appointed by the Dean and the ATM Director.
Term
Ex-officio members are members as long as they hold their administrative appointment. Appointed members are members for a one-year term and are eligible for renewal upon mutual agreement between the chair, the FoM Dean, the ATM Director, and the appointee.
Chair
The RAC will be chaired by an internal chair from UBC. The chair will be appointed by the Dean and the Director of ATM. In the event that the chair will be absent for an extended period, they will delegate their responsibilities to another member of the RAC, with the agreement of the Dean and ATM Director.
Meeting Schedule and Administration
• Council meetings are normally 90 minutes, quarterly.
• All members are expected to attend all meetings via videoconference or phone for the foreseeable future. In person meetings may occur in the future, with remote connection options for members not located in Vancouver.
Meeting minutes and action items will be captured by ATM administrative staff and circulated to all members following the meeting. Minutes will be approved by the chair.
Quorum and Decision-Making Process
Meetings will normally be cancelled if fewer than half of members can attend.
This advisory council provides advice based on the input of all members. Members typically reach consensus on that advice, but may convey multiple perspectives if consensus does not emerge.
Lines of Accountability and Communication
Council members are accountable to their host organizations. The Council is accountable to the ATM Director and the Dean.
The Council chair will communicate decisions, recommendations and guidelines to the ATM Executive Council and the Director of the ATM.
Responsibilities
This council will:
• Discuss specific challenges and pertinent topics (1-3 topics per meeting) to develop understanding and advice for the ATM leadership on navigating regulatory roadblocks, e.g. o Identify outdated requirements in regulatory processes;
- Issues related to approval vs. adoption in clinical medicine.
• Develop strategy for – and guide the ATM leadership in – the development an academic program in regulatory affairs & policy setting.
• Guide ATM leadership in creating materials to support ATM members, e.g. o High-level regulatory roadmaps for development of new discoveries;
- List of key questions to consider during development of a new discovery;
- List of potential partners to approach early on.
• Address concerns and recommendations brought forward by the ATM advisory councils (Industry, Education and Data Commons), e.g. o Topics and speakers for education programs to increase the general understanding of regulatory affairs;
- Ethical considerations for use of patient data.
In between meetings, the RAC will provide feedback to ATM leadership and/or other ATM advisory councils as needed and will work closely with the councils and the ATM leadership to draft briefing notes and recommendations for health authorities and policy makers.
Materials to facilitate discussions and advancement will be developed by the RAC with support from ATM leadership and administrative staff.
Approval
This version of these terms of reference have been approved by:
The Director of the ATM on May 20, 2022, and the Chair of the ATM Regulatory Advisory Council on May 26, 2022.