Aug 28, 2014RSS Feeds As A Regulatory Intelligence Tool:
Which websites should regulatory professionals be reading, and how should they be reading them?
Sep 07, 2015 - Sep 08, 20157th Science to Market
The annual discussion and partnering conference for experts from academia, biotechnology and pharmaceutical industry for the European Assiociation of Pharma Biotechnology (EAPB)
Dec 18, 2014 - Dec 18, 2014Webinar "Regulatory requirements for a market access of Medicines and Medical Devices – a comparison"
§ 1. Name and registered office of the Association
1. The Association shall bear the name: "Europäische Arbeitsgemeinschaft fuer Pharma Biotechnologie (EAPB) e.V." (European Association for Pharma Biotechnology - Association Européenne de Pharma Biotechnologie). The Association shall be active independently around the world, with a primary focus on the territories of the member states of the European Union, particularly during an initial phase of two years.
2. The Association has its registered office in Berlin and is enrolled in the Register of Associations.
§ 2. Purpose of the Association
1. The purpose of the Association shall be to promote science and research.
2. This purpose shall be realised in particular by:
a) promoting pharmaceutical biotechnology, especially the exchange of knowledge between scientists in universities and in industry as well as scientific co-operation with other scientific companies through information exchange (seminars, symposiums).
b) contributing to the modernisation and updating of the training of scientists active in pharmaceutical biotechnology and thus improving the state of staff training.
c) using the World Wide Web for specific information in pharmaceutical biotechnology, e.g., technology transfers or discussion forums. Access to the Association's home page shall be free of charge.
d) supporting scientific journals through the Association's own editorial contributions for the promotion of pharmaceutical biotechnology. The Association may operate a journal. Such journal shall be published and distributed by an external publishing house. No income shall be earned. Published copies of the journal shall be available to the general public. In addition, the results of third-party research and documentation shall be published in a timely fashion.
e) creating guidelines and recommendations in pharmaceutical biotechnology.
f) co-ordinating the teaching material of training courses and courses of study in the biotechnology sector at a European level through Association events (colloquiums, workshops, laboratory internships) which serve to transmit expert knowledge.
§ 3. Non-profit nature
1. The Association shall exclusively and directly pursue non-profitable purposes in the terms of the Tax Code section entitled, "Tax-favoured purposes". The Association shall be active in a selfless fashion; it shall not foremost pursue its own financial purposes.
2. The funds of the Association may only be used for purposes pursuant to these Articles of Association. The members of the Association may not receive any allocations from the Association's funds. The Association may not favour any person through expenses not related to the purpose of the Association or through disproportionately high compensation.
3. In the event of the dissolution of the Association or the elimination of tax-favoured purposes, the assets of the Association shall accrue to a public-law corporation or to another tax-favoured entity which must use the assets directly and exclusively to promote science and research.
§ 4. Members
1. The following shall be members of the Association:
a) natural persons;
b) corporate members (industrial companies, research institutions and scientific organisations);
c) honorary members who have rendered outstanding services in the interests of the Association.
2. The requirements for membership in the Association shall be:
a) readiness to support the goals and tasks of the Association as described in § 2 hereof;
b) with regard to natural persons, the holding of an academic degree from a university or higher technical college.
§ 5. Acquisition and cessation of membership
1. Membership may only be gained by written application which must be approved by the chairperson.
2. Membership shall cease through:
a) the withdrawal of a member with a notice period of three months effective from the end of any calendar year;
b) an exclusion by the Executive Committee for sufficient cause after the member has been given an opportunity to respond; c) the death of the member.
§ 6. Financing of the Association
1. The Association shall be financed through membership fees, allocations, donations and promotional funds.
2. The annual membership fees shall be determined by the directors. Honorary members shall be released from the obligation to pay membership fees.
§ 7. Bodies of the Association
The following shall be the bodies of the Association:
1. the members in general meeting;
2. the Executive Committee;
3. the Board of Governors.
§ 8. General membership meetings
1. General meetings of members shall be held every two years or whenever the Executive Committee so resolves. The Executive Committee shall be obligated to convoke a meeting if at least 25% of the members file a corresponding motion.
2. General meetings of members shall be convoked by the Executive Committee. Meetings shall be convoked in writing at least two months prior to the established meeting date, specifying the location and items on the agenda.
3. Motions of individual members relating to general membership meetings are to be submitted in writing up to four weeks prior to the general membership meeting.
4. A quorum shall be constituted at each general membership meeting convoked pursuant to these Articles of Association. Modifications of these Articles of Association and the dissolution of the Association may only be carried out by way of a three-fourths majority. Otherwise, resolutions shall be adopted by way of a simple majority. Absent members may have themselves represented by another member based on a written proxy. In the event a general membership meeting cannot be convoked, resolutions may be adopted by circulatory written ballot. The majority relations shall correspond to those in general membership meetings. Motions for resolutions shall be formulated by the Executive Committee.
5. The members in general meeting shall have the following duties:
a) to receive the activity report of the Executive Committee and Board of Governors;
b) to approve the actions of the Executive Committee;
c) to vote on motions of the Executive Committee and members;
d) to elect the Executive Committee;
e) to appoint the independent auditor;
f) to vote on modifications of these Articles of Association;
g) to vote on the dissolution of the Association.
6. Minutes are to be kept of the course of meetings, and are to be signed by the chairperson and the elected minutes-keeper.
§ 9. Rules of procedure
The Executive Committee shall prepare rules of procedure. The rules of procedure may be modified by majority resolution of the members in general meeting.
§ 10. Executive Committee
1. The Association shall be directed and administered by the Executive Committee.
2. The Executive Committee shall consist of the following:
a) the chairperson;
b) two vice chairpersons (1st and 2nd vice chairpersons);
c) the scientific secretary;
d) the treasurer
e) the managing director (not mandatory; if in function: contracted, not elected)
3. Directors in the terms of §26 of the Civil Code shall be the chairperson and the treasurer. Both shall be authorised to sign alone on behalf of the Association and may represent the interests of the Association.
In times, when EAPB has a managing director, this person has to run the operational business of the association and is authorized to sign contracts after consulting and agreement with the president or the treasurer. This agreement has to be documented together with the referring contract.
Two-person integrity between president and treasurer is mandatory only in cases for contracts valid more than 5000,- EUR.
4. The Executive Committee shall manage the ongoing business of the Association. Resolutions shall be adopted by way of a simple majority.
5. The members of the Executive Committee shall be elected by the members in general meeting by way of a simple majority for a term of two years. In the event of a parity of votes, the vote of the acting chairperson shall be decisive. Members may be re-elected.
6. Meetings of the Executive Committee are to be held at least once a year. They may be convoked at any time by the chairperson or by way of a majority resolution of the Executive Committee.
7. A quorum shall only be constituted at Executive Committee meetings provided at least three members are present. Each member shall have one vote. In the event of a parity of votes, the vote of the chairperson shall be decisive.
8. The Executive Committee shall report to the Board of Governors on fundamental issues.
§ 11. Duties of the Executive Committee:
1. The chairperson shall preside over the meetings of the Association and the Executive Committee. He or she shall present at each general membership meeting the annual report, which shall provide information about the state of the Association. The chairperson shall convoke ordinary and extraordinary general membership meetings and the meetings of the Executive Committee and the Board of Governors.
2. The first and second vice chairpersons shall advise the chairperson and represent him or her in meetings in the chairperson's absence.
3. The scientific secretary shall represent the Executive Committee in all international activities of the Association.
4. The treasurer shall be responsible for the accounting of the Association. The treasurer shall provide information regarding the finances of the Association at the meetings and shall present annual accounts at the membership meetings of the Association.
§ 12. Board of Governors
1. The Board of Governors shall advise and support the Executive Committee in the performance of its duties.
2. The Board of Directors shall consist of four (4) persons if the Association has up to 300 members. If the Association has over 300 members, the Board of Directors shall be expanded to eight (8) persons.
3. The Executive Committee shall elect the Board of Governors. Elections for the Board of Governors shall be held, at the latest, one month after the Executive Committee has been elected. Votes shall be cast at a meetings, by post or email.
§ 13. Associate Governors
The Executive Committee may give members special powers of attorney in order to perform extraordinary duties (associate governors). Such duties shall exist, for example, during the organisational phase of the Association or during the holding of general membership meetings or scientific conferences. The term of office of associate governors shall be limited by the Executive Committee.
§ 14. Fiscal year
The fiscal year of the Association shall correspond to the calendar year.
§ 15. Auditing
The members in general meeting shall appoint two (2) independent auditors who do not belong to the Executive Committee. Such independent auditors shall be responsible for auditing the entire accounting of the Association. The auditors must audit the annual accounts at the end of each fiscal year. A written report on the audit is to be prepared and presented to the members in general meeting.
§ 16. Dissolution of the Association
1. The Association may only be dissolved by way of a three-fourths majority of all full members in a general meeting convoked for this purpose. In the event less than three-fourths of all full members are present, a new general membership meeting must be convoked within four weeks, specifying the agenda item "Dissolution of the Association", at which meeting three-fourths of all full members present may resolve to dissolve the Association.
2. Affiliation with another scientific company while simultaneously dissolving the Association shall require the approval of three-fourths of all members of the Association.
§ 17. Invalidity of resolutions
1. In the event any modifications of these Articles of Association are made due to objections of the Registration Court or the Revenue Service prior to the entry of the Association in the Register of Associations or in the event any other appropriate editorial modifications are necessary, the Executive Committee may adopt and/or announce such modifications.
2. In the event any modifications of these Articles of Association are or become invalid or null and void, the remaining provisions of these Articles of Association shall not be affected thereby.
§ 18. Binding force
Solely the German version of these Articles of Association shall be legally binding. The Executive Committee shall be authorised to prepare or have translations of this version prepared in any language it chooses.
Frankfurt am Main, September 30, 2014