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Rules of procedure

§ 1 General concept
1. In order to work successfully in the spirit of these Statutes, all activities of the
Association must be in line with a uniform organisational and strategic concept.
To design such concept, the Executive Committee shall develop short-, medium-, and long-term proposals and present them to the Extended Board for deliberation.
2. The concept shall be reviewed and, if necessary, modified and further developed
at least at annual intervals. The corresponding agenda may only be discussed
under the direction of the President of the Executive Committee. All Board
members, particularly those with management responsibility, must assure the
conformity of their action with the agreed strategy. All Board members shall be
called upon to provide the President of the Executive Committee suggestions for
future strategies.

§ 2 Executive Committee
1. The Executive Committee shall put forward to the Membership Assembly or to
the Members per e-mail/post those of Executive Committee's members who are
standing for election. The Membership Assembly and the Members shall not be
bound by the nominations. Candidates may moreover be nominated by at least
15 Members.
2. The Executive Committee shall meet at least once per year.
3. The invitations shall be declared by the President with the agenda, observing a
notice period of two weeks. The date for the annual meetings to take place in
preparation for the Membership Assembly are to be scheduled long in advance.
"European Working Society for Pharmaceutical Biotechnology, a Registered
Association"
4. The President shall be obligated to invite Members, if requested by the majority
of the Executive Committee or half the Extended Board.
5. A quorum of the Executive Committee shall be constituted when at least three of
its members are present. Should such a presence not be achieved, resolutions
are to be brought about by writing.
6. The President may invite persons pertaining to the Executive Committee to
meetings if their attendance is necessary for deliberation on an agenda item.
7. Minutes must be kept of the resolutions of the Executive Committee; such
minutes must be signed by the President and the Secretary and preserved.
8. The work in the Executive Committee shall be rendered on an honorary basis.
The costs of travel to the meetings of the Board and the events of EAPB shall
normally not be reimbursed. The Executive Committee may decide on
exceptions upon request.
9. When elected by the General Assembly or by the members per e-mail/post, the
Executive Committee elects the officers of the Association: President, First Vice
President, Second Vice President, Scientific Secretary, and Treasurer.
As a transitional arrangement for the first upcoming election after the foundation of
the society, 3 members of the Executive Committee will be elected for 4 years, 2
members for 2 years (i. e. the 2 persons who will be elected by the Executive
Committee as President and Scientific Secretary will have only an election period of
2 years). Then at the next election in 2005 the 2 members with expired office time
will be elected for a 4 year period and thereafter 3 or 2 of the members of the
Executive Committee will be up for election every 2 years.

§ 3 President
1. The President of the Executive Committee shall represent the Association in
relation to third parties and shall co-ordinate the activities internally. The
President shall be responsible for the ongoing business within the framework of
the Statutes and these Rules of Procedure.
2. The President shall also chair the meetings of the Extended Board.
3. The President shall bear direct responsibility for the employees of the
Association. The Executive Committee shall resolve on contracts with relevancy
in labour law and other measures.
4. EAPB is an associated section of the European Federation of Biotechnology
(EFB), the President of EAPB is an ex officio member of the Executive Board of
EFB representing EAPB as the official associated section "Pharma Medical
Biotechnology" of EFB. In this function the title of the EAPB President is
"Chairman" of the EFB section.

§ 4 First and Second Vice President
In co-operation with the President, the First Vice President shall prepare the
scientific conferences of the Association and shall be responsible together with the
President for the publication of the Association journal. In the absence of the First
Vice President, the Second Vice President shall assume the former's duties.

§ 5 Scientific Secretary
The activities of the Scientific Secretary shall encompass the organisation of
workshops, annual scientific congresses and other events. The Scientific Secretary
shall also be responsible for the public relations work of the Association, e.g.
Association advertising, public comments, etc.

§ 6 Treasurer
1. The Treasurer shall be responsible for the fact that the expenses of the
Association basically stay within the framework of the available coverage.
Borrowings shall only be permissible with the approval of the Executive
Committee.
2. The financial plan is to be prepared by the Treasurer for each financial year two
months prior to the start thereof.
3. The financial plan shall consist of the following individual plans:
a) general administration
b) purchases
c) events
d) website
e) journal
The estimates shall be prepared by the Treasurer based on the
recommendations of technically qualified Board members. The Executive
Committee shall bear the responsibility for the overall financial plan.
4. When listing the anticipated revenue, it must be indicated whether
corresponding claims exist or what other quality the anticipated revenue has.
Expenses which are to be covered through still unapproved subsidies are to be
flagged with a restriction notice until the approval is issued.
5. Extraordinary expenses within the framework of the reserves established in the
financial plan shall require the approval of the Treasurer at the request of the
Executive Committee.
6. The Treasurer shall implement the financial plan. A semi-annual status report
shall be prepared, which must contain all due and contingent liabilities. The
Treasurer shall inform the other Board members of any material variations from
the financial plan that are detected.
7. By the decision of the Executive Committee, the Treasurer can also have the
function of an additional Scientific Secretary. In this case this position will be
called "2nd Scientific Secretary & Treasurer", i. e. the society has two Scientific
Secretaries.

§ 7 General Secretary
1. The office of EAPB will be run by a General Secretary. The General Secretary is
in charge of all office duties and works in cooperation with the President.
2. The General Secretary is appointed by the Executive Committee in its first
constitutional meeting after the election. The period of office of the General
Secretary ceases with the period of office of the Executive Committee or
alternatively by a 2/3 majority vote of the members of the Executive Committee.
3. The General Secretary is an additional appointed member of the Executive
Committee having full rights including voting rights, that means the Executive
Committee is extended to 6 members in total.
4. The General Secretary is in charge of EAPB press releases in cooperation with
the President (e. g. EAPB Forum in the journal NewDrugs), periodic mails to the
members of EAPB and a special mail service for the corporate members. He
also provides information material to the Treasurer to be placed on the EAPB
homepage.
5. In addition to the President the General Secretary officially represents the society
EAPB in different matters in case the President is not present (e. g.
representation at meetings or conferences, negotiations with other societies or
representation on the Executive Board of the European Federation of
Biotechnology (EFB)).

§ 8 Special interest groups (SIG)
EAPB can found special interest groups (SIG) to cover certain areas of EAPB
activities. Examples are SIG "Regulatory affairs", "Networking", "European Union"
and "Education". Any member of EAPB can sign in for such a group. The SIG is
being run by an SIG Chairlady/Chairman, there is also a Vice Chairlady/Chairman.
The foundation meeting of an SIG can optionally be organised by the General Office
of EAPB. At the foundation meeting the Chairlady/Chairman and Vice
Chairlady/Chairman are elected by the SIG group members present. The period of
office is 2 years. The writing of the protocols will be organised by the
Chairlady/Chairman. One copy will by archived by the Chairlady/Chairman. A
second copy will be provided to the Central EAPB Office in Berlin to be placed in the
general archive.

§ 9 Extended Board
1. The Extended Board shall be elected by the Executive Committee.
The Extended Board shall consist of four (4) persons if there are up to 300
Members of the Association. If there are more than 300 Members, the Extended
Board shall be extended to 6 (six) persons. Four or 6 members of the Extended
Board shall be nominated to the Executive Committee by the Corporate
Members; such nominations shall normally be accepted by the Executive
Committee. The Corporate Members shall decide on the list of nominees in
election by majority of votes. In the event of a tie, the lot cast by the President
shall decide. Candidates may be nominated by each Corporate Member; the
Executive Committee shall likewise have the right to nominate candidates. The
elections shall transpire parallel to the election of the Executive Committee by
the entire Membership.
2. The Extended Board shall meet as necessary. The Extended Board shall make
decisions by way of a simple majority. At least three members shall participate
in meetings. In the interim, the Extended Board shall reach agreement by
writing.
3. Proposals for the concept of the Association are to be discussed at least once
per year by the Managing and Extended Boards. A draft resolution shall be
necessary to prepare for the deliberation; the Extended Board shall provide
advisory support for the draft.
4. The President or the First or Second Vice President as substitutes shall decide
on the acceptance of new Members. The exclusion of a Member shall be
presented to the Extended Board by the Executive Committee for deliberation.
5. The work in the Extended Board shall be rendered on an honorary basis. The
costs of travel to the meetings of the Board and the events of EAPB shall
normally not be reimbursed. The Executive Committee shall decide on
exceptions upon request.

§ 10 Associate Members of the Executive Committee
1. In accordance with the statutes the Executive Committee may furnish Members
with special powers of attorney to perform extraordinary duties (Associate
Members). The term of office of the Associate Members appointed by the
Executive Committee shall cease automatically with the term of office of the
Executive Committee.
2. An Associate Member shall be assigned to the Executive Committee to promote
co-operation with the European Federation of Biotechnology (EFB). At the start of
each term of office, the EFB shall appoint the person for this position; the
appointment shall be confirmed by the Executive Committee.
3. An Associate Member shall be assigned to the Executive Committee to promote
co-operation with the Mid-European Group of Regulatory Affairs Professionals
(MEGRA) and the Pan-European Federation of Regulatory Affairs Societies
(PEFRAS); such Member shall represent both organisations. MEGRA and
PEFRAS shall consult with each other and appoint the person for this position at
the start of each term of office; the appointment shall be confirmed by the
Executive Committee.

§ 11 Dues
1. The Executive Committee shall each year establish the dues in accordance with
the financial needs of the Association.
2. Individual members shall be exempt from the payment of dues.
3. Corporate Members shall pay in accordance with the size of their enterprises.
4. Honorary Members shall be exempt from the payment of dues.
5. Each Member shall be obligated to pay the full membership dues punctually.
The Association office is to be informed of any changes of address.

§ 12 Events
1. The Association shall endeavour to incorporate major scientific developments,
relevant topics for public opinion forming & public perception and political and
regulatory issues in pharmaceutical biotechnology early on in its events
(conferences, workshops, expert meetings etc.) and to make such
developments the topic of events.
2. For this purpose, the Association shall maintain connections and/or cooperation
with other societies and public and scientific institutions in order to
pursue its goals alone or in connection with other organisations.
3. The Executive Committee shall appoint the persons responsible for carrying out
events of the Association.
4. The Membership Assembly shall be conducted if possible in connection with a
scientific congress in Europe (e.g. European Congress on Biotechnology (ECB)
or the World Congress on Pharmaceutics, Biopharmaceuticals and
Biotechnology).

§ 13 Relations to other scientific societies
1. The Association shall co-operate with national scientific societies in Europe in
order to promote pharmaceutical biotechnology in general and to organise
scientific congresses, workshops, and training and advanced training courses.
2. The Association shall seek contact with other scientific societies active on a
European level in order to promote co-operation in the field of pharmaceutical
biotechnology and to harmonise European initiatives in this field.
3. The Association shall maintain contacts to scientific societies whose interests
are likewise in the field of pharmaceutical biotechnology.
4. The Association may become a member in supranational or global
organisations active in the field of pharmaceutical biotechnology.

§ 14 Publicity
1. Each Member of the Association shall be free to express his or her views on
cultural policy and particularly on the activity of the Association. The Association
shall not make any comment in this regard. Opinions expressed in lectures,
discussions, etc. shall be the personal opinions of the speakers.
2. Only the President of the Executive Committee shall be entitled to make public
statements in the name of the Association.

§ 15 Effective date
These Rules of Procedure shall take immediate effect.

Frankfurt am Main, September 30, 2014