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Draft TERMS OF REFERENCE
EXPERT WORKING GROUP (EWG)
on POSITRON EMITTING RADIOPHARACEUTICALS (PERs)
- MANDATE
To provide the Director General and the management team of the Biologics and Genetic Therapies Directorate with informed feedback, recommendations, and advice regarding the PERs regulatory framework. Specifically:
to review the Directorate draft Issue Analysis Summary on the regulatory framework for PERs; to develop an action plan to define and address the issues raised during the review; and to monitor the implementation of recommendations.
In addition, the EWG may be asked to advise on specific questions raised by the Biologics and Genetic Therapies Directorate.
- MEMBERSHIP
The EWG will have two types of members, Core and Corresponding members, selected for their expertise, knowledge and experience in the field. Core Members will be permanent members for the duration of the working group. Corresponding Members will only be invited to attend meetings on a specific topic or group of topics.
The number of Core Members will not exceed eleven people.
The EWG will not be chaired. The meetings will be conducted using a facilitated process.
At the discretion of the EWG, interested parties or concerned members of the public may be invited to make representations to the EWG in writing or in person, or may be granted observer status.
Health Canada staff will not serve as members of the Panel, but will provide Secretariat support and respond to questions and provide information as needed.
- REPORTING STRUCTURE
The EWG reports to the Director General, Biologics and Genetic Therapies Directorate. The Director General will be accountable to the EWG for the provision of feedback in a timely fashion.
- OPERATIONS
The EWG will meet once every 4 months or as needed.
All members of the EWG have equal status during discussion. The Directorate will provide Secretariat support from the Policy and Promotions Division and respond to questions and provide information as required.
Consultants At the discretion of the EWG the services of specialized consultants can be used to provide advice on a particular issue.
Observers Observers may be identified at the discretion of the EWG.
- PROPOSED TENURE/LIFE CYCLE
Expert working groups have a finite term and once the mandate is fulfilled the group will be disbanded. The need for continuing advice will be considered by the Director General. The members will be appointed for the duration of the EWG.
An individual may withdraw from service on the EWG at any time upon written notification to the Director General. Members who are absent from three consecutive meetings will forfeit membership in the EWG. If a replacement member is required the new member will be chosen from the same group.
- SECURITY CLEARANCE AND CONDUCT
All EWG members will be required to undergo a security clearance to the level of "enhanced reliability" and to make full disclosure of real or perceived conflicts of interest according to current Health Canada policy guidelines.
The members will serve on the EWG as knowledgeable individuals in their own right advising Health Canada on optimal PER practices and processes.
EWG members are expected to conduct themselves in an appropriate manner, i.e. the use of their positions cannot be reasonably construed to be for their private gain or that of any other person, company, or organization. They must refrain from any conflict of interest and, indeed, its very appearance. In situations where conflict of interest, or the appearance thereof, arises in the course of the work of the EWG, the individual involved must declare its existence and disqualify himself/herself from participation in the discussion, and/or from further membership on the EWG according to the circumstances or specific situation(s).
Guidance on conflict of interest will be provided to potential members when discussing the appointment. Before appointment, EWG members will be required to submit conflict of interest declarations to disclose to Health Canada any circumstances that may place, or be seen to place, the member in a real, apparent or potential conflict of interest. It will be incumbent upon the member to update his/her disclosure, should his/her personal situation change.
Confidential or protected documents leaving Health Canada must be securely stored at all times, and must be returned to Health Canada. All members are expected to protect and maintain as confidential any trade secret or privileged information divulged during the work of the EWG. Members must not discuss this information with persons not on the EWG, or divulge information obtained from the work of the EWG, including presentations made to it, until such time as this information has been officially released for public distribution.
- COMPENSATION
Nonindustry Members will be compensated for travel expenses according to federal government policy. Honoraria will be paid only if membership on the EWG results in economic hardship. Specific contractual arrangements will be made should additional work be offered or assigned to EWG members.
- MANAGEMENT AND ADMINISTRATION
The specific questions and issues for EWG discussion will be determined by the EWG, with input from Health Canada staff. The agenda will be developed by the EWG and the Health Canada Secretariat. Members will receive an agenda, briefing materials and other documentation in advance of meetings. Notice of the meeting will be provided to members two weeks in advance.
Meetings will be held in the National Capital Region, or by teleconference if the need arises. There will be scheduled meetings every 4 months, with additional meetings if necessary.
In order to remain effective and efficient, the EWG should not ordinarily exceed 11 attending members for any meeting. A quorum shall consist of six Core Members.
Discussion during meetings will be encouraged to be open, frank and free-flowing and all members of the EWG will have equal status during discussion. In cases where the information to be discussed is confidential, discussions will be held in camera. Minutes of meetings will be circulated to members, and will be made available externally at the discretion of the Director General. This record will be kept to the minimum detail required to summarize effectively the proceedings and to accurately reflect the decisions taken. There will be no attribution. The Secretariat will be responsible for the distribution of records of decisions. There will be no other recording of meetings. Since the minutes of the EWG meetings will be disclosable, confidential third party information or confidential information obtained from other governments should be attached as an appendix, and must be clearly identified and marked as confidential.
Decisions of the EWG will be reached by consensus, and will be in the form of recommendations to the Director General, BGTD. Lack of consensus may indicate uncertainty of information. In such cases, a recommendation must be made with respect to further study of the issue and a proposal for resolution.
Health Canada will review the EWG annually to ensure that the EWG continues to meet on-going needs. The Department retains the prerogative to disband the EWG following such review or at any time.
- THIRD PARTY INDEMNIFICATION AND PROVISION OF LEGAL ASSISTANCE
A. Third Party Indemnification
Volunteer members of the EWG who provide advice without compensation other than the reimbursement for their actual expenses will be given third party risk protection similar to that received by departmental employees when faced with comparable risks of third party liability in accordance with the Treasury Board Policy on Volunteers.
B. Legal Assistance
Past and present volunteer members of the EWG who provide advice without compensation other than the reimbursement for their actual expenses will receive legal assistance at public expense where the legal proceeding results from the provision of expert advice to Health Canada by the volunteer EWG member in accordance with the mandate of the EWG and applicable professional standards.
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