INTERNAL REGULATIONS OF SEFH’S ORPHAR WORKGROUP
1. STRUCTURE
- A coordinator
- A secretary
- A steering committee (maximum 8 members)
- A representative from SEFH’s Governance Board
- A trainee (at the discretion of the Steering Committee, a trainee may be appointed following a public call for candidates through SEFH’s website)
- A resident (only if there are candidates available)
- Associate members supporting the workgroup’s activities (optional)
The workgroup will be led by a coordinator, who must be a SEFH member appointed following an election by the members. The workgroup’s secretary, like the coordinator, will be appointed by consensus between the members. The task of the steering committee will be that of getting as many hospital pharmacy departments as possible to contribute as much information as possible so that the workgroup is in an optimal position to serve SEFH members. The steering committee will be made up by a maximum of 8 members, apart from the coordinator and the secretary. The remaining components will also be SEFH members working in the area of orphan drugs. SEFH’s Governance Board may also invite experts in the area of orphan drugs to join the workgroup. SEFH’s representative will participate in the workgroup’s meetings to facilitate communication between the workgroup and the Governance Board.
2. DUTIES
2.1. The coordinator
- Manage the workgroup’s activities.
- Coordinate the workgroup’s activities with those of other SEFH workgroups.
- Liaise with SEFH’s Governance Board and SEFH’s workgroup coordinator.
- Establish the goals to be achieved, the tasks to be performed and the workplan to be followed, by consensus with the other workgroup members
- Prepare, together with the secretary, an annual report of the workgroup’s activities, which must be sent to SEFH’s Technical Secretariat.
- Advise SEFH on all matters related to orphan drugs.
- Coordinate the workgroup’s participation in SEFH’s annual congresses.
- Supervise the maintenance of the workgroup’s website and twitter account.
The coordinator may delegate some of their functions in other workgroup members, as appropriate.
2.2. The secretary
- Liaise with SEFH’s workgroup coordinator and Technical Secretariat.
- Prepare the minutes of all workgroup meetings and send a copy thereof to SEFH’s Technical Secretariat.
- Assist the workgroup’s coordinator in preparing an annual report of the workgroup’s activities.
- Supervise the maintenance of the workgroup’s website and twitter account.
The Secretary may delegate some of their functions in other workgroup members, as appropriate.
2.3. The steering committee
- Attend the workgroup’s meetings. Unjustified absence from three consecutive meetings may entail a member’s exclusion from the workgroup. In such cases, the coordinator or the secretary must discuss the matter with the rest of members.
- Actively collaborate with the coordinator and the secretary in establishing the workgroup’s annual goals, implementing the workgroup’s projects, and make contributions toward the advancement of the management of orphan drugs.
- Assist the scientific committee of SEFH’s national congresses in reviewing the abstracts of articles dealing rare diseases or orphan drugs.
- Assist SEFH in reviewing the therapeutic positioning reports on orphan drugs it receives.
- Participate in the activities carried out during SEFH’s annual congresses.
2.4. Trainee
- Maintenance of the workgroup’s website and twitter account.
- Manage their own projects.
- Perform such tasks as may be entrusted to them by the coordinator or the secretary.
3. PARTICIPACIÓN DE LOS SOCIOS
The workgroup is open to any SEFH member interested in joining it. Registrations may be made from the SEFH website’s members only area or through the workgroup’s website. Admissions shall be decided by the workgroup’s steering committee and subject to such requirements as being a SEFH member and being in some way involved in the management of rare diseases and orphan drugs.
The workgroup shall use its website as its main communication channel. The steering committee shall post on the website the minutes of the workgroup meetings as well as the details of the trailing activities organized and any other information considered relevant to the workgroup members. Members may use the e-mail address This email address is being protected from spambots. You need JavaScript enabled to view it. to send in their comments and suggestions, as well as any information they may deem relevant for the workgroup members.
Members wishing to leave the workgroup must send an e-mail to that effect to the coordinator or the secretary.
4. FUNCTIONING RULES
Workgroup regulations
The workgroup regulations and any amendments thereof must be adopted by consensus. Proposals must be supported by at least 50% of possible votes.
Meetings
Workgroup meetings will be held at SEFH’s headquarters. They shall be attended by the coordinator, the secretary and the other members of the steering committee, as well as the trainee and the residents’ representative, if any. SEFH’s Governance Board representative will also be invited to attend.
A minimum of one in-person meeting shall be held every year.
The coordinator/secretary will call the meeting by e-mail, attaching the meeting’s agenda. Any member can request for an item to be added to the agenda.
The agreements adopted at the workgroup meetings shall be adopted by simple majority. At least 50% of possible votes must be cast for a motion to carry.
The secretary shall take the minutes of every meeting and send them to SEFH’s Technical Secretariat.
Annual workplan
A workplan shall be prepared every year, which will cover the following points:
- Annual goals
- Pending matters
- Projects to be developed and work calendar
- Meetings to be held
5. MEMBERSHIP RENEWAL
Renewals will take place during the first quarter of every year.
The workgroup coordinator and secretary shall be elected every two years for a maximum term of four years (two elections). Both will be elected by the steering committee.
To encourage active participation of the widest possible range of members, twenty percent of the steering committee’s membership shall be renewed every 2 years, unless otherwise agreed by the majority. Steering committee membership elections will be informed through SEFH’s mailing list in order that both workgroup members and other SEFH members may present a candidacy.
The steering committee, including its outgoing members, shall choose the new members by consensus or simple majority, based on certain criteria, such as their membership in the workgroup, their degree of involvement with rare diseases, their motivation, etc.
Workgroup grants will be awarded for one years, although their length may be extended to two years. To apply for a grant, candidates must submit a report including all the activities they have performed. Grants will be open to all SEFH members and shall be publicized through SEFH’s website and mailing list.
6. FINANCIACIÓN
The workgroup shall be founded by a fixed allowance granted by SEFH to defray the expenses required for the operation of its workgroups. In order to access such funds, the workgroup must every year submit to SEFH’s Governance Board a report of its activities of the previous year and a workplan for the next two years.
The workgroup shall strive to obtain additional funds to those mentioned above in order to embark on more ambitious projects. Such funds may be obtained either from the competitive grants periodically awarded by SEFH or by applying for other kinds of subsidies, grants or awards to fund specific projects.
On exceptional occasions, pharmaceutical companies interested in collaborating with the development of projects undertaken by the pharmaceutical compounding workgroup may be approached for support.
7. DISOLUCIÓN DEL GRUPO
Dissolution of the workgroup may be decided for any of the following reasons:
- The goals pursued by the group have been achieved/the tasks envisaged have been completed.
- The workgroup has not conducted any activities for two consecutive years.
- The initially proposed goals have ceased to be relevant.
- The workgroup has infringed SEFH’s workgroup operational regulations
Dissolution of the workgroup may be requested in writing by the coordinator or any member of SEFH’s Governance Board, stating the reasons for the request.