ISPE BELGIUM AFFILIATE VZW, AFGEKORT : ISPE BELGIUM

Dénomination : ISPE BELGIUM AFFILIATE VZW, AFGEKORT : ISPE BELGIUM

Forme juridique : Association sans but lucratif

N° entreprise : 563.884.061

Publication

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behouden aan het Belgisch

Staatsblad

Bijlagen bij het Belgisch Staatsblad - 14/10/2014 - Annexes du Moniteur belge

Allen van Belgische nationaliteit

Artikel 1:

De vereniging zonder winstoogmerk draagt de naam ISPE Belgium Affiliate en heeft haar maatschappelijke

zetel te 2880 Bornem, Breevenstraat 54

De vereniging ressorteert onder het gerechtelijk arrondissement Mechelen

De vereniging is een filiaal van ISPE Inc, ingeschreven in Tampa-Florida-Verenigde Staten, hierna genoemd

ISPE Inc en waarvan de statuten ( bylaws) daterend november 2012 hierna worden bijgevoegd.

Artikel 2:

De vereniging heeft tot doel:

� de verzorging van de voortgezette opleiding van technici en vaklui in de farmaceutische industrie en de

Verklaren op datum van 21 augustus 2014 tussen hen een vereniging zonder winstoogmerk (vzw) te willen oprichten overeenkomstig de bepalingen van de wet van zevenentwintig juni negentienhonderd eenentwintig en waarvan de statuten als volgt werden samengesteld :

TITEL I Benaming, doel en zetel

De heer DE CLERCQ Jozef, geboren te Hingene op 15 februari 1953 en wonende te 2880 Bornem,

Breevenstraat 54

De heer BALERIAUX Patrick, geboren te Charleroi op 20 maart 1961 en wonende te 6120 Ham-sur-Heure-

Nalinnes, rue du Louvroy 2

De heer HUYBRIGHS Jan, geboren te Mol op 7 mei 1960 en wonende te 9190 Stekene, Voorhout 107

De heer FOLLEBOUCKT Jean-Jacques, geboren te Brugge op 8 april 1953 en wonende te 1030 Brussel, de

Jamblinne de Meuxplein 38

De heer FOLIE Geoffroy, geboren te Nijvel op 4 april 1968 en wonende te 1380 Lasne, rue Mathy 8

STATUTEN

Ondergetekenden,

Ondernemingsnr :

Benaming

(voluit) : ISPE Belgium Affiliate vzw

Onderwerp akte : Oprichting

(afgekort) : ISPE Belgium

Rechtsvorm : Vereniging zonder winstoogmerk

Zetel : Breevenstraat(BOR) 54

*14309340*

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2880

Belgi�

0563884061

In de bijlagen bij het Belgisch Staatsblad bekend te maken kopie na neerlegging ter griffie van de akte

Bornem

Griffie

Neergelegd

10-10-2014

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Voorbehouden aan het Belgisch Staatsblad

ermee verwante nijverheidstakken, vooral op het gebied van naleving van de voorschriften.

� het handelen als een forum voor de uitwisseling van idee�n en meest recente informatie betreffende de door de overheid opgelegde voorschriften.

� de bevordering en promotie van de belangen van de aangesloten leden op gebied van farmaceutische

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nijverheidsexpertise

� de uitbouw van de farmaceutische professional als beroep en de beklemtoning en promotie van de

verdienstelijke rol van dit beroep.

� De bevordering en de aanmoediging van opbouwende relaties onder zijn leden en met de ermee verband

houdende beroepen.

Zij mag daartoe alle nodige roerende en onroerende goederen in huur of gebruik nemen, verwerven, bezitten,

verhuren en vervreemden. Zij mag alle activiteiten organiseren en uitoefenen die het doel dienen.

TITEL II - Leden, aanvaarding, uittredingen

Artikel 3:

Het aantal leden is onbeperkt maar moet minstens 3 bedragen.

Bijlagen bij het Belgisch Staatsblad - 14/10/2014 - Annexes du Moniteur belge

Artikel 5:

Elk effectief lid van de vereniging is vrij uit te treden door het indienen van zijn ontslag door aanduiding op het

jaarlijks hernieuwingsformulier.

Het lidmaatschap eindigt van rechtswege indien het lidmaatschap van ISPE Inc be�indigd is.

De uitsluiting van een effectief lid kan slechts door de algemene vergadering worden uitgesproken met een

meerderheid van twee derde van de stemmen van de aanwezige of vertegenwoordigde leden.

Artikel 4:

Om effectief lid te zijn van de vereniging moet men:

a) lid zijn van ISPE Inc en in Belgie verblijven of er werken

b) niet expliciet aangeven geen lid te willen zijn van ISPE Belgium Affiliate. De effectieve leden zijn geen lidmaatschapsbijdrage verschuldigd aan ISPE Belgium Affiliate

Artikel 6:

Een effectief lid dat ontslag neemt of dat wordt uitgesloten, alsook de erfgenamen van een overleden lid, hebben

geen aanspraak op het bezit van de vereniging.

Artikel 7:

De vereniging kan toegetreden leden, sponsors of ereleden aanwerven. Deze worden niet aanzien als effectieve

leden van de vereniging.

TITEL III Algemene vergadering

Artikel 8:

De algemene vergadering bestaat uit al de effectieve leden van de vereniging.

De toegetreden leden, sponsors en de ereleden maken geen deel uit van de algemene vergadering.

Een besluit van de algemene vergadering is vereist voor de aangelegenheden die door de wet of door deze

statuten bepaald zijn.

De algemene vergadering benoemt indien nodig, de bedrijfsrevisor voor een periode van 3 jaar, die hernieuwbaar

is.

Ieder lid heeft ��n stem.

Artikel 9:

Er zal jaarlijks voor 30 juni op een locatie bepaald door de raad van bestuur, een algemene vergadering

gehouden worden op dag en uur te bepalen door de raad van bestuur. Alle leden moeten ertoe uitgenodigd

worden.

Buitengewone algemene vergaderingen zullen bijeengeroepen worden door de raad van bestuur, telkenmale dat

deze het nuttig zal oordelen voor de belangen van de vereniging.

De bijeenroeping van een algemene vergadering door de raad van bestuur is verplichtend binnen de maand na

een schriftelijke en met redenen omklede aanvraag van minstens een derde van de leden aan de voorzitter van

de raad van bestuur..

De bijeenroeping geschiedt tenminste 8 dagen v��r de vergadering bij gewone brief of per email voor de gewone

zowel als voor de buitengewone vergadering.

De algemene vergadering is geldig samengesteld indien minstens de helft van de leden aanwezig of

vertegenwoordigd zijn bij volmacht en haar beslissingen worden genomen bij eenvoudige meerderheid van de

uitgebrachte stemmen, tenzij door de wet anders is bepaald. Bij gelijkheid van stemmen is de stem van de

voorzitter van de vergadering beslissend.

Indien een algemene vergadering niet geldig kan vergaderen omdat het vereiste quorum van de leden niet

aanwezig of vertegenwoordigd is, kan een nieuwe algemene vergadering bijeengeroepen door de voorzitter van

de raad van bestuur tenminste 8 dagen vooraf de vergadering, geldig vergaderen over dezelfde agenda,

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ongeacht het aantal aanwezigen

Artikel 10:

De algemene vergadering wordt voorgezeten door de voorzitter van de raad van bestuur. Indien de voorzitter verhinderd is, kan hij het voorzitterschap mandateren aan een ander lid van de raad van bestuur, zoniet neemt het oudste aanwezige lid van de raad van bestuur het voorzitterschap van de algemene vergadering waar. Ieder lid van de vereniging mag zich laten vertegenwoordigen op de algemene vergadering door een volmachtdrager voorzien van een geschreven machtiging, voor zover de gevolmachtigde zelf lid is van de vereniging.

Een gevolmachtigde kan slechts ��n lid van de vereniging vertegenwoordigen.

Artikel 11:

De notulen van de algemene vergadering worden opgenomen in een register en ondertekend door de voorzitter en de secretaris.

Het register wordt opgemaakt door de secretaris van de raad van bestuur van de vereniging en bewaard op de sociale zetel van de vereniging..

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TITEL IV - Bestuur

Artikel 12:

De vereniging wordt bestuurd door een raad van bestuur benoemd door de algemene vergadering voor

onbepaalde duur.

Elke bestuurder dient het document Volonteer Code of Conduct en de eventuele toekomstige bijstellingen

ervan te ondertekenen. Niet ondertekening van dit document houdt van rechtswege ontslag in als lid van de raad

van bestuur. Dit document wordt door de vereniging ISPE Inc overgemaakt aan de vereniging.

De modaliteiten voor de verkiezing van de bestuursmandaten wordt geregeld door een huishoudelijk reglement,

genaamd: ISPE Belgium Affiliate Guidelines versie 2.0 dd 14 mei 2014 hierbijgevoegd.

Het mandaat van bestuurder eindigt van rechtswege bij de be�indiging van het lidmaatschap van de vereniging.

Artikel 13:

De raad van bestuur vergadert op uitnodiging van de secretaris, waarbij de uitnodigingsbrief of email de plaats en

het tijdstip vermeldt. De uitnodigingsbrief of -email vermeldt tevens de dagorde. De bijeenroeping van de raad

van bestuur wordt verplichtend wanneer minstens ��n derde van zijn leden het aanvraagt.

Artikel 14:

De raad van bestuur treedt op als college. De beslissingen worden genomen bij eenvoudige meerderheid van

stemmen. Bij gelijkheid van stemmen is de stem van de voorzitter van de vergadering beslissend. Indien er, in

geval van geheime stemming, gelijkheid van stemmen is, wordt het voorstel verworpen.

De raad van bestuur kan slechts geldig beraadslagen indien minstens de helft van de leden aanwezig is, de

schriftelijke verontschuldigingen niet meegerekend.

Wordt deze voorwaarde niet vervuld, dan wordt een nieuwe vergadering belegd met dezelfde dagorde minstens

8 dagen vooraf de vergadering.. Op deze vergadering zijn de beslissingen geldig ongeacht het aantal aanwezige

leden.

Artikel 15:

De raad van bestuur heeft de meest uitgebreide machten inzake bestuur. Alles wat niet uitdrukkelijk

voorbehouden wordt aan de algemene vergadering, hetzij door de statuten, hetzij door de wet, behoort tot de

bevoegdheid van de raad van bestuur.

Artikel 16:

De raad van bestuur kan dagelijkse bestuursopdrachten mandateren aan een dagelijks bestuur of aan een van

de leden ervan..

Voor alle handelingen die vallen buiten deze dagelijkse bestuursopdrachten zoals het verwerven, vervreemden of

in pand geven van onroerende goederen, aangaan van leningen, eisen en verdedigen voor de rechtbank, enz, is

de gezamenlijke handtekening van de voorzitter en van een lid van het dagelijks bestuur vereist.

Artikel 17:

De bestuurders nemen geen persoonlijke verplichtingen op zich betreffende de verbintenissen van de vereniging.

Ze zijn alleen verantwoordelijk voor het uitvoeren van hun mandaat.

Artikel 18:

Van elke vergadering van de raad van bestuur worden notulen opgesteld, waarin minstens de besluiten van de

vergadering zijn opgenomen. De notulen worden op de eerstvolgende vergadering formeel goedgekeurd.

De notulen van de raad van bestuur worden opgenomen in een register.

Het register wordt bewaard door de secretaris van de raad van bestuur van de vereniging en ondertekend door

de voorzitter en de secretaris.

TITEL V Dagelijks Bestuur

Artikel 19:

Het dagelijks bestuur van de vereniging aangesteld conform de bepalingen van artikel 16 hierboven bestaat uit

minimum 3 en maximum 5 leden met volgende functies:

voorzitter ��n of twee ondervoorzitter(s) secretaris schatbewaarder

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De leden van het dagelijks bestuur worden verkozen door de algemene vergadering. De leden van het dagelijks bestuur zijn na verloop van elke termijn herkiesbaar.

Om tot lid van het dagelijks bestuur verkozen te worden, dient de kandidaat minstens gedurende de voorafgaande periode 6 maand lid te zijn ven het bestuur van de vereniging.

De leden van het dagelijks bestuur ondertekenen jaarlijks het document The International Society for Pharmaceutical Engineering Inc Belgium Affiliate Charter year xx . Niet ondertekening van dit document houdt van rechtswege ontslag als lid van het dagelijks bestuur in. Dit document wordt jaarlijks voorgelegd aan ISPE Belgium Affiliate door ISPE Inc.

Andere modaliteiten aangaande de werking van het dagelijks bestuur worden geregeld in het huishoudelijk reglement genaamd ISPE Belgium Affiliate Guidelines versie 2.0 dd 14 mei 2014 en hier bijgevoegd.

Bijlagen bij het Belgisch Staatsblad - 14/10/2014 - Annexes du Moniteur belge

TITEL VI - Begroting en rekeningen

Artikel 20:

Ieder jaar, op 31 december, worden de rekeningen van het verlopen dienstjaar afgesloten.

Elk jaar wordt een begroting opgemaakt voor het volgend jaar.

TITEL VII - Ontbinding, vereffening

Artikel 21:

De ontbinding van de vereniging zal beslist worden door de algemene vergadering op de wijze vastgelegd door

de wet.

Artikel 22:

Na ontbinding van de vereniging zal door de algemene vergadering haar bezit toevertrouwd worden aan ISPE Inc

waarvan het maatschappelijk doel het doel van de huidige vereniging benadert.

Artikel 23:

Voor al hetgene dat door deze statuten niet uitdrukkelijk geregeld is, is de wet van 27 juni 1921, gewijzigd bij de

wet van 2 mei 2002 en andere latere wijzigingen regelende de werking van de vzw s , van toepassing.

DE CLERCQ Jozef, BALERIAUX Patrick, FOLIE Geoffrey, HUYBRIGHS Jan, FOLLEBOUCKT Jean-Jacques, waarvan gegevens hogervermeld.

Het aldus aangestelde bestuur, duidt volgende personen aan als lid van het dagelijks bestuur ten voorlopige titel tot de eerstkomende algemene vergadering:

Article I: Organization

Op deze stichtingsvergadering worden volgende personen aangesteld als bestuurder:

Sec. 1. Name. The name of this organization shall be International Society for Pharmaceutical Engineering, Inc. ( ISPE or Society ).

DE CLERCQ Jozef, voorzitter

BALERIAUX Patrick, 1ste ondervoorzitter

FOLIE Geoffrey, 2de ondervoorzitter

HUYBRIGHS Jan, secretaris

FOLLEBOUCKT Jean-Jacques, schatbewaarder

ISPE Bylaws Revised 10 February 2014

Sec. 2. Seal. The corporate seal shall have inscribed thereon the name of the Society, the year of its incorporation, and the state of incorporation.

Sec. 3. Affiliates and Chapters. In order to facilitate more frequent information exchange and networking among members of the industry, the Society shall form national or regional Affiliates and local Chapters. These groups shall be chartered by the Society, said charter to be reviewed annually. Affiliates and Chapters shall draft bylaws to guide their operation, consistent with the bylaws of the Society, said bylaws to be approved by the ISPE Board of Directors. Affiliates and Chapters shall elect their own Board of Directors which is responsible to the ISPE Board of Directors for complying with the provisions of the Charter.

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Article II: Purposes

Sec. 1. Promote Interests. To be the leading technical organization for professionals engaged in producing quality medicines and pharmaceutical devices throughout the lifecycle. All applications for membership are subject to review by the International Board of Directors for qualification based on job functions.

Sec. 2. Education Programs. To promote and support educational programs designed to enhance competence, compliance, professional performance and enable innovation.

Sec. 3. Information and Guidance. To provide information and guidance to regulatory authorities with respect to practices affecting the pharmaceutical, biotechnology, medical device, and diagnostic industries.

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Sec. 1. Industry Members. Any individual engaged in producing quality medicines and pharmaceutical devices throughout the lifecycle is eligible to become an Industry Member. Industry Members are entitled to the full rights of membership including to vote on matters pending before the Society, hold office, and serve as volunteers on behalf of the Society. Membership in one Affiliate/Chapter of the Society is included with each Industry membership. Industry Members have voting rights and may serve on committees and hold any office of the Affiliate/Chapter. Industry memberships are not transferable.

Article III: Membership

There shall be nine classes of membership:

1. Industry Members

2. Regulatory Authority/Government

3. Young Professional Members

4. Student Members

5. Academic Members

6. Emerging Economy

7. Honorary

8. Emeritus

9. Hardship

Sec. 4. Industry Integrator. To foster relationships and provide opportunities for interaction among individual members, industry constituencies including suppliers, government and academia.

Sec. 5. Information. To collect and disseminate information for its members.

Sec. 6. Establish Profession. To enhance the image of pharmaceutical science, engineering, and technology as a profession and promote its importance within the industry.

Sec. 7.Credentialing. To establish and administer credible credential programs to further and promote the interests of members, industry and the public.

Sec. 8. Not-for-Profit. ISPE is an incorporated organization operating on a not-for-profit basis.

Sec. 2. Regulatory Authority/Government Members. Any individual employed full-time by a regulatory authority or government agency is eligible to become a Regulatory Authority/Government Member.

Regulatory Authority/Government Members will have access to all materials included in the Member- restricted section of the ISPE web site. Regulatory Authority/Government Members are entitled to the full rights of membership including to vote on matters pending before the Society, hold office, and serve as volunteers on behalf of the Society. Regulatory Authority/Government memberships are not transferable and will expire upon departure from the regulatory authority or government agency.

Sec. 3. Young Professional Members. Individuals engaged in producing quality medicines and pharmaceutical devices throughout the lifecycle are eligible to become Young Professional Members during the first four years they work in the industry. Young Professional Members are entitled to the full rights of membership including to vote on matters pending before the Society, hold office, and serve as volunteers on behalf of the Society. Membership in one Affiliate/Chapter of the Society is included with each Young Professional membership. Young

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Professional Members have voting rights and may serve on committees and hold any office of the Affiliate/Chapter. Young Professional memberships are not transferable and some benefits may be limited.

Sec. 4. Student Members. Individuals enrolled full-time in pharmaceutical science, technology, engineering, mathematics, or related disciplines at a recognized educational institution may enter the Society as Student Members while they are enrolled and for one year following graduation. Students attending at least half time are eligible if their primary concentration is education, such as a combination of class work and an internship. Student Members shall be entitled to limited benefits in the Society (International, local Affiliates, local Chapters) to include serving as volunteers on behalf of the Society and voting on matters pending before the Society. Student Members may not hold office at the local or International levels. Membership in one Student Chapter of the Society is included with each Student membership. Student Members have voting rights in the Student Chapter and may serve as officers, directors, and volunteers.

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Sec. 5. Academic Members. Any individual employed full-time by an educational institution that agrees to promote educational programs aimed at developing pharmaceutical science, technology, engineering, mathematics, or related disciplines is eligible to become an Academic Member. Academic Members are entitled to the full rights of membership including to vote on matters pending before the Society, hold office, and serve as volunteers on behalf of the Society. Membership in one Affiliate/Chapter of the Society is included with each Academic membership. Academic Members have voting rights and may serve as volunteers on behalf of the Society and hold any office of the Affiliate/Chapter. Academic memberships are not transferable.

Economy Members are entitled to limited Society benefits, including to vote on matters pending before the Society, hold office, and volunteer on behalf of the Society. Emerging Economy memberships are not transferable.

Sec. 8. Emeritus Members. Any individual who has held membership in the Society for five consecutive years, upon full retirement from business and professional activity, shall be eligible for emeritus status with a reduced dues rate. Emeritus Members shall be entitled to limited Society benefits, including to vote on matters pending before the Society, hold office, and volunteer on behalf of the Society. Emeritus memberships are not transferable.

Article IV: Meetings

Sec. 1. Annual Meeting. An annual membership meeting will be held each year. The time and place of the annual membership meeting of this organization shall be determined by the Board of Directors. The Secretary shall cause to be mailed to every member in good standing at his address as it appears in the membership roll book of this organization a notice telling the time and place of such Annual Meeting.

Sec. 2. Special Meetings. Special meetings of this organization may be called by the ISPE Chair when (s)he deems it for the best interest of the organization. Notices of such meetings shall be mailed to all members at their addresses as they appear in the membership roll book at least thirty (30) days before the scheduled date set for such special meeting. Such notice shall state the reasons that such meeting has been called, the business to be transacted at such meeting and by whom called. At the request of two-thirds members of the Board of Directors, the ISPE Chair shall cause a special meeting to be called, but such request must be made in writing at least thirty (30) days before the requested scheduled date. No other business but that specified in the notice may be transacted at such special meeting without the unanimous consent of all present at such meeting.

Sec. 6. Emerging Economy Members. Individuals engaged in producing quality medicines and pharmaceutical devices throughout the lifecycle in countries that the Society shall classify as Emerging Economies are eligible to become Emerging Economy Members of the Society. Membership in one Affiliate/Chapter of the Society is included with each Emerging Economy membership. Emerging

Sec. 7. Honorary Members. The ISPE Chair and President may designate Honorary Members in order to accommodate those who are able to make special contributions to the Society. Honorary Members shall be entitled to limited Society benefits, including to vote on matters pending before the Society, hold office, and serve as a volunteer on behalf of the Society. Honorary memberships are not transferable.

Sec. 9. Hardship Members. Any individual who is an active Member, upon becoming unemployed may request reduced annual dues until employment is found. These individuals shall be entitled to limited Society benefits, including to vote on matters pending before the Society, hold office, and serve as a volunteer on behalf of the Society. Contribution to the Society will be considered along with length of membership.

Sec. 3. Quorum. TEN (10) members present at any meeting of the Society shall constitute a quorum.

Article V: Voting

Sec. 1. Voice Vote. At all meetings of this Society, issues requiring a vote for resolution shall be referred to the eligible voting Members there present for a voice vote determination of the majority position.

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Election of Officers and Directors of the Society shall be an exception in which the voting process will require secret ballot. Unless specified otherwise in these bylaws, results of voting will be determined by a simple majority.

Sec. 2. Other Voting Procedures. At any meeting, the presiding officer may require or a majority of those voting members present may request a vote be by show of hands or by secret ballot.

Sec. 3. Inspectors of Election. The Nominating Committee shall appoint one or more persons to act as Inspector(s) of Election. The Inspector(s) shall at the conclusion of balloting certify in writing to the Chair the results. A copy of the results shall be physically affixed to the minutes of the meeting.

Sec. 4. Inspector Conflict. No inspector of election shall be a candidate for office or shall be personally interested in the question voted upon.

Article VI: International Board of Directors

Sec. 3. Meetings.

Article VII: Officers

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Sec. 1. Board Organization. The Board of Directors shall be composed of not less than three (3) and not more than sixteen (16) members including the Officers of this organization and the Past Chair. The Directors shall be elected prior to and inducted at the Annual Meeting of this organization. The Directors shall serve a term of two (2) years effective upon election, the Officers for one (1) year. A Director may not sit on the Board for longer than four (4) consecutive years unless that individual is elected an Officer. The President shall serve as a non-voting member of the Board of Directors.

a. A simple majority of the members of the Board of Directors shall constitute a quorum. The act of a majority

of the Directors present at a meeting at which a quorum is present shall be the act of the Board of the Directors, unless the act of a greater number is required by law or by these bylaws. Directors may attend a meeting by telephonic or similar equipment by means of which all persons participating can hear each other. Meetings of the Board of Directors shall be held not less than four times per year. Notice for each meeting of the Board of Directors shall be issued not less than thirty (30) days prior to the time appointed for such meeting.

b. Special meetings of the Board of Directors may be called by the Chair or the President, or by the majority of

the voting Directors then in office who may fix any place as the place for holding any special meeting. Notice of any special meeting shall be given at least two (2) days previous thereto by written notice delivered personally or sent by mail, e-mail or facsimile to each Director. The purpose of the special meeting shall be stated in the meeting notice.

Sec. 4. Vacancies. Unscheduled vacancies in the Board of Directors may be filled by a vote of the majority of the remaining members of the Board of Directors for the balance of the unexpired term. Officer vacancies will be filled from among the most qualified Directors, if possible.

Sec. 6. Board Votes. Each Director shall have one vote and voting shall not be done by proxy. Should the ISPE Chair deem a vote of the Board of Directors to be necessary to occur between meetings of the Board, such a vote may be cast by telephone, facsimile, e-mail, or mail. The results of such a vote will be included in the minutes of the next regularly scheduled meeting of the Board.

The primary responsibility of each Officer shall be to manage the affairs, funds, and property of the Society, while advancing ISPE s intent to be the leading technical organization for professionals engaged in producing quality medicines and pharmaceutical devices throughout the lifecycle. The Officers of the organization shall be as follows:

Sec. 2. Function. The Board of Directors shall govern the affairs and business of this organization. Such Board of Directors shall only act in the name of the organization when it shall be convened or assigned by the Chair.

Sec. 5. Removal. A Director may be removed when sufficient cause exists for such removal. The Board of Directors may entertain charges against any Director. Removal must be effected by not less than two- thirds majority of the entire Board of Directors by secret ballot.

1. Chair

2. President

3. Vice Chair

4. Treasurer

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5. Secretary

Sec. 1. Chair. The ISPE Chair shall preside at all Board and membership meetings. (S)he shall present at each Annual Meeting of the organization an annual report of the work of the organization. (S)he shall appoint chairpersons of all committees, temporary or permanent, with the approval of the Executive Committee. (S)he shall assure that all books, reports and certificates as required by law are properly kept or filed. (S)he shall be one of the Officers who may sign the checks and drafts of the organization. (S)he shall have powers as may be reasonably construed as belonging to the Chair of the Board of any organization.

Sec. 2. President. The President shall be authorized to execute the annual business plan approved by the Board of Directors, enter into agreements on behalf of the Society, and manage the daily operations of the Society. The Board of Directors shall hire the President. The Executive Committee shall fix the compensation of the President and conduct an annual performance review. The President shall be responsible for hiring and supervising all members of the International Staff and shall serve as Chief Executive Officer of the Society. (S)he shall be one of the Officers who may sign the checks and drafts of the organization and shall be the official spokesperson for the Society.

Article VIII: Staff

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Sec. 6. Director Compensation. No elected Director shall by reason of his/her office be entitled to receive any salary or compensation. Reasonable expenses incurred by a Director of the Society while conducting business for the Society will be reimbursed. Prior approval from the ISPE Chair or President as specified in the policies of the organization is necessary.

The Board of Directors shall establish total Staff compensation as part of the annual budgeting process and approve personnel policies.

Article IX: Committees and Other Volunteer Groups

The governance committee chairpersons of this organization whose identities are not specified in the Board-approved Governance Structure shall be appointed by the ISPE Chair, with approval by the Executive Committee, and their terms of office shall be for a period of one (1) Society year or until their successors are appointed. The chairpersons of operating committees shall be recommended by the President. Operating Committees, Councils, Teams, Forums, and Communities of Practice may be established as deemed necessary by the President in consultation with ISPE Chair or International Board of Directors.

Sec. 1. Rules for Governing Committees. At least 50 percent of committee members shall constitute a quorum for transaction of committee business. Only members of the Society may be appointed to serve on committees. Committee chairpersons shall ensure that minutes are taken for all committee meetings and distributed to the ISPE Chair.

Sec. 3. Vice Chair. (S)he shall perform the duties of the ISPE Chair in the Chair s absence and shall succeed the ISPE Chair in the event that the Chair is unable to complete his/her tenure of office.

Sec. 4. Treasurer. The Treasurer shall have the responsibility to monitor the collection and disbursement of all monies belonging to the organization and shall be assisted by the Staff of the Society with such monies or securities of the organization. (S)he shall cause to be deposited in an insured financial institution the funds of the Society. (S)he may be one of the Officers who may sign checks or drafts of the organization. (S)he shall render at such stated periods as the Board of Directors shall determine a written account of the finances of the organization and such report shall be physically affixed to the minutes of the Board of Directors of such meeting. (S)he shall prepare for the Board of Directors approval an annual operating budget, said budget to cover the forthcoming Society year.

Sec. 5. Secretary. The Secretary shall keep the minutes and records of the Board of Directors and of the Society. It shall be the duty of the Secretary to file any certificate required by any statute, federal or state. (S)he shall give and serve all notices to members of this organization. (S)he shall be the official custodian of the records and seal of this organization. (S)he may be one of the Officers authorized to sign checks and drafts of the organization. (S)he shall attend to all correspondence of the organization and shall exercise all duties incident to the office of Secretary.

Sec. 2. Nominating Committee. This committee will consist of the Board Officers plus three Past Chairs, one young professional, one Chapter Chair, one Affiliate Chair, the President, and any appropriate additional representatives as determined by the ISPE Chair. The committee shall thoroughly review the active membership in recommending a final slate. The final list of nominees shall be reviewed by the International Board of Directors for final approval prior to being voted on by the full membership. The proposed candidates shall be contacted to determine their interest and have their responsibilities explained.

Sec. 3. Executive Committee. This committee will consist of all elected Officers, the immediate Past Chair, and

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the President, who shall not have a vote. The Committee may exercise the powers of the International Board of Directors when the Board is not in session, reporting to the Board at its succeeding meeting on any action taken.

Article X: Dues

Sec. 1. The dues of this organization shall be payable on the anniversary date of ISPE membership, or as determined by the International Board of Directors. The amount of the dues shall be determined by the Board of Directors. A portion of the membership dues determined annually is allocated for a non- deductible subscription to the Society s Magazine, Pharmaceutical Engineering.

Sec. 2. Annual dues are payable on receipt. Any member who has failed to remit dues payments within 30 days shall be sent a second billing along with notification that membership will automatically be canceled unless remittance is received within 30 days.

Article XI: Amendments

Revision table:

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These bylaws may be altered, amended, or repealed and new bylaws may be adopted by a majority of the Directors present at any regular meeting or at any special meeting, if at least seven days written notice is given of intention to alter, amend, or repeal or to adopt new bylaws at such meeting.

Article XII: Indemnification

Society s expense, insurance on behalf of the Society and on behalf of others to the extent that power to do so has been or may be granted by statute, and give other indemnification to the extent not prohibited by law.

Article XIII: Gender

Whenever used in these bylaws, the singular shall include the plural, the plural shall include the singular, and pronouns shall be read as masculine, feminine or neuter as the context requires.

Article XIV: Procedure

The rules contained in the most recent edition of Robert s Rules of Order shall provide the rules of procedure for the Society where they are not inconsistent with the provisions of the Articles of Incorporation or these bylaws.

Sec. 1. Every Officer, Director, employee of the Society and such others as specified by the International Board of Directors, shall be indemnified by the Society against all expenses and liabilities including counsel fees, reasonably incurred or imposed upon them in connection with any proceeding to which they may be made a party, or in which they may become involved by reason of being or having been an Officer, Director or employee of the Society, or any settlement thereof, whether the person is an Officer, Director or employee at the time such expenses are incurred, except in such cases wherein the Officer, Director or employee is adjudged guilty of willful misfeasance or malfeasance in the performance of duties. The foregoing right of indemnification shall be in

addition to and not exclusive of all rights to which the indemnified may be entitled.

Sec. 2. The International Board of Directors shall have the power to purchase and maintain, at the

ISPE Belgium Affiliate Guidelines

Version Reason for modification Date

0. Initial issue 09/03/2011

1.1 Creation of a Non-Profit Organization 21/02/2013

Following Committee meeting 20/2/2013

1.2 Agreed by the Committee on 20/3/2013 20/03/2013

2.0 Creation of vzw/asbl 14/05/2014

Content:

1. GOALS OF ISPE BELGIUM AFFILIATE.. 2

2. THE COMMITTEE.. 2

2.1. Role of the Committee. 2

2.2. Composition of the Committee. 2

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2.3. Designation of the Committee. 2

2.4. Attendance to the committee meetings. 3

2.5. Decisions of the Committee. 3

3. THE BOARD OF OFFICERS OF THE COMMITTEE.. 3

3.1. Role of the Board.. 3

3.2. Composition of the Board.. 3

3.3. Designation of the Board.. 3

4. THE COMMITTEE MEETINGS. 4

4.1. Schedule. 4

4.2. Agenda.. 4

5. THE SUB-COMMITTEES. 4

5.1. Organization and purpose. 4

5.2. Meetings. 5

5.3. Election Sub-Committee. 5

6. REVIEW OF THE COMMITTEE GUIDELINES. 5

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2. THE COMMITTEE

2.1. Role of the Committee

To organize and implement all necessary activities in order to achieve the goal.

To manage the Non-Profit Organization ISPE Belgium Affiliate vzw/asbl.

2.2. Composition of the Committee

The Committee is the Board of Directors of ISPE Belgium Affiliate vzw/asbl.

The Committee shall be composed of minimum 6 members and maximum 20 members.

The Committee shall be representative of the following main sectors where life sciences professionals are active,

i.e.

1) Pharmas and biotechs;

2) Contract Manufacturers and Contract Research Organizations;

3) Suppliers, equipment manufacturers and service providers for the

pharma industry;

4) Medical devices and clinical laboratories.

The majority and as a fair target no more than 2/3 - of the Committee members should be employed by

companies from the first two sectors.

The Committee Members should preferably represent the different functions from R&D over the global supply chain.

The Committee Members should preferably not be more than 2 from the same company.

Committee Members must be members of ISPE Belgium Affiliate vzw/asbl.

2.3. Designation of the Committee

The Committee Members are elected for an unlimited period of time.

Election will take place every 3 years during the last quarter of the third year for effectiveness on the first January

of the next year. Election will apply for the first time during the last quarter of 2014.

Voters shall be all the members of ISPE Belgium Affiliate vzw/asbl.

Election shall be by secret ballot.

The Chairman shall call for candidates at least two months before election starts.

Candidates for becoming Committee Member must be members of ISPE Belgium Affiliate vzw/asbl.

Candidates for becoming Committee Member shall submit their application by writing to the Chairman at the

latest one month before the election starts.

Shall become Committee Members the candidates who received the highest number of votes, in the limits of the

number of positions to be filled and according to the rules expressed in article 2.2.

In case of resignation of a Committee Member between two elections, the Committee can replace the position

until the next election.

In case a Committee Member changes of position, function or company between two elections, the Committee

Member may remain member of the Committee until the next election even in case some provisions of the

chapter 2.2. are not met anymore.

2.4. Attendance to the committee meetings

Meeting attendance should be equally distributed over the calendar year, with a minimum attendance of 5

Committee Meetings per calendar year.

professional learning, education & benchmarking;

representing ISPE Global at local level (membership growth for the organization);

giving support to Belgian life sciences for continued growth.

1. GOALS OF ISPE BELGIUM AFFILIATE

Be recognized as the standard professional organization for Belgian life sciences, for,

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When a Committee Member does not meet the expected attendance, the Secretary will kindly remind him the rule

2.4.1.

When a Committee Member does not meet the expected attendance during two consecutive calendar years, the

Chairman of the Board will propose him to resign from the Committee.

2.5. Decisions of the Committee

Decisions of the Committee are taken at the majority of the Committee Members present at the meeting, provided

at least half of the Committee Members are effectively present, written apologies deducted.

The vote of the Chairman of the Committee shall make the difference in case of equality.

Committee Members cannot give a proxy.

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4. THE COMMITTEE MEETINGS

4.1. Schedule

Committee Meetings shall be organized at least 8 times a year.

At least one physical Committee Meeting shall take place every two months. Other Committee Meetings may be

by other means (e.g. teleconf).

The Secretary shall communicate the schedule of the Committee Meetings to all Committee Members by e-mail

with at least 4 months notice.

The Secretary shall send a reminder by e-mail to all Committee Members two weeks before the meeting.

Attendance should be confirmed at least 72 hours in advance to both the Secretary and the Meeting Host.

Cancellation should be announced without delay.

4.2. Agenda

Proposed agenda shall be attached to the reminder.

Any Committee Member shall have the opportunity to add a topic to the agenda. This could be done with the

attendance confirmation.

3. THE BOARD OF OFFICERS OF THE COMMITTEE

The Board of Officers of the Committee is here after referenced as The Board .

3.1. Role of the Board

To ensure the day-to-day management of the Non-Profit Organization ISPE Belgium Affiliate vzw/asbl.

3.2. Composition of the Board

The Board shall be made of minimum 3 and maximum 5 Board Officers, in charge of the following positions:

- One Chairman (mandatory)

- One or two Vice-Chairman(s) (optional)

- One Secretary (mandatory)

- One Treasurer (mandatory).

Board Members are Committee Members.

Each Officer will sign on yearly basis the ISPE Membership Bylaws.

3.3. Designation of the Board

The Board Officers are elected for a period of 3 years.

Election will take place every 3 years during the last quarter of the third year for effectiveness on the first quarter

of the next year. Election will apply for the first time during the last quarter of 2014.

Voters shall be all members of ISPE Belgium Affiliate vsw/asbl.

Election shall be by secret ballot.

The number of Vice-Chairman positions shall be fixed by the Committee before the call for candidates.

The Chairman shall call for candidates at least two months before election starts.

Candidates for becoming Board Officers must be Committee Members for at least 6 months.

Candidates for becoming Board Officers shall submit their application for the positions they trust, by writing to the

Chairman at the latest one month before the election starts.

For each position, shall be elected the candidate who received the highest number of votes.

In case of resignation of a Board Officer between two elections, the Committee can replace the position until next

election.

5. THE SUB-COMMITTEES

5.1. Organization and purpose

Sub-committees can be organized following a decision of the Committee to address particular topics.

Sub-committees can be permanent or spot depending on the topics to be addressed.

Sub-committee Members shall be volunteer Committee Members.

Sub-committees may invite external advisors when required.

For each Sub-committee a Coordinator shall be designated amongst and by the Sub-Committee Members.

The Sub-committee Coordinator shall regularly inform the Committee on the progress of the Sub-committee

works.

Dissolution of a sub-committee shall be decided by the Committee.

5.2. Meetings

The Sub-committee Coordinators shall schedule and organize the Sub-committee meetings.

5.3. Election Sub-Committee

The Election Sub-committee shall have the responsibility to organize the election of the Committee Members and

of the Board Officers.

The Election Sub-committee shall be chaired by the Chairman of the Board and composed of minimum 3 and

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maximum 7 Committee Members, the Chairman included.

Counting of the votes shall be the responsibility of the Election Sub-Committee, who will allocate the different

positions in line with the provisions foreseen by the here above chapters 2 and 3.

All exceptions to the rules will be part of arbitration by the Election Sub-Committee.

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6. REVIEW OF THE COMMITTEE GUIDELINES

Committee Guidelines shall be reviewed every year during the first Committee Meeting.

Jef De Clercq Patrick Baleriaux Geoffroy Folie Jan Huybrighs Jean-Jacques

Follebouckt

Chairman Vice-Chairmen Vice-Chairmen Secretary

Treasurer

Volunteer Code of Conduct

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As constituents of a not-for-profit, multidisciplinary, and neutral forum for sharing information that optimizes the process of pharmaceutical manufacturing and life cycle management, Volunteers should reflect the diversity in the global membership. The spirit of this document attempts to uphold ISPE s principles:

Collaboration in the pursuit of our mission.

Ethical behavior that is worthy of trust, respect, and admiration from others internally and externally.

Professionalism characterized by behaviors and communications that are honest, fact- based and politically neutral; courtesy and consideration toward other people; high standards and integrity in all that we do; and constructive problem-solving.

Inclusiveness that allows for active and rewarding participation by Members working throughout the global pharmaceutical supply chain.

Volunteers will at all times abide by and conform to the following Code of Conduct in their capacity as an ISPE Volunteer:

General Expectations

1. Volunteers will contribute to a collegial, inclusive, positive, and respectful work environment for fellow Volunteers, stakeholders, and staff, and they will model the best in professional behavior.

2. Volunteers will know, understand, and support ISPE s mission, core purpose, values, goals, strategies, and annual directives. They will also become familiar with and follow ISPE s policies, procedures, guidelines, and the Volunteer Code of Conduct while acting on behalf of ISPE.

3. Volunteers will not discriminate and will be respectful of ethnic, national, and cultural differences.

4. Volunteers will only use ISPE s marks, insignia, name, logos, and trade dress (collectively, ISPE Marks ) in compliance with guidelines issued by ISPE from time to time.

5. Volunteers will obey all applicable laws and regulations of the relevant government authorities, including all laws and provisions that govern appropriate conduct in the work place while acting on behalf of ISPE.

6. Volunteers will make or recommend decisions in the best interests of ISPE as a whole rather than focusing on any ISPE subpart or advocating options that advance a personal concern.

1. While acting on behalf of ISPE, professional behavior and respectful discourse is required of Volunteers. Disruptive, inappropriate, or harassing behavior toward other Volunteers, stakeholders or staff is unacceptable.

2. Personal boundaries set by others must be observed. Sexual harassment including but not limited to unwelcome sexual advances, requests for sexual favors, and other verbal or physical harassment of a sexual nature will not be tolerated.

3. Only information deemed for public knowledge may be shared or discussed outside ISPE, unless specifically authorized to do so by the President/CEO and/or the Board Chair. No Volunteer will share, copy, reproduce, transmit, divulge or otherwise disclose any confidential information related to the affairs of the Society.

4. Volunteers will uphold strict confidentiality regarding any information discussed at meetings or in the course of any other deliberations and communications. Questions regarding the confidential nature of ISPE information or documents will be directed to the appropriate staff person or Board member.

5. Volunteers may not speak on behalf of ISPE or the Board to external parties, such as the media or other interested parties unless specifically asked to do so by the President/CEO.

6. Volunteers may not speak as subject matter experts on behalf of ISPE internally or externally unless authorized to do so in accordance with ISPE procedures.

7. All contractual agreements are the responsibility of ISPE staff in accordance with established authority and procedures. Volunteers cannot make contractual commitments on behalf of ISPE with the exception of Board officers formally granted such authority by the Board s policies.

8. All ISPE correspondence, regardless of the medium, is a reflection on the Society. E-mail communications

Meetings and Communication

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will follow the same professional standards as verbal communication. E- mails may be considered legal documents and, therefore, caution must be exercised when recording written opinions and statements pertaining to the role of any ISPE Volunteer(s). The use of the blind copy function is strongly discouraged when conducting official ISPE business.

9. Volunteers will be supportive in communicating about ISPE to other Volunteers, Members, and stakeholders.

Inappropriate communication by email or in any public forum about ISPE, its Volunteers, staff, stakeholders, policies, procedures or guidelines is not acceptable. Issues regarding ISPE will be taken up in private with the appropriate ISPE staff member.

10. Participation in committee meetings (in-person and/or teleconferences as determined by each committee) is typically required to fulfill a Volunteer s duties.

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Relationship with Other Volunteers, Stakeholders and Staff

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1. Volunteers may not attempt to exercise individual authority over their respective volunteer groups, nor may they purport to represent the organization or their respective volunteer groups to other ISPE volunteers, stakeholders or staff, except as explicitly set forth in ISPE s Governance Structure.

2. Volunteers will understand the scope of their authority and exercise good judgment in their dealings with other Volunteers, stakeholders, staff, suppliers and the general public. Accordingly, volunteers will respond to all Members and stakeholders in a prompt, responsible, respectful and professional manner, and they will represent their role within ISPE clearly and accurately.

3. Volunteers will not request special/personal favors or confidential/embargoed information from other Volunteers, stakeholders, or staff without prior consultation and agreement of the President/CEO.

4. ISPE events are professional gatherings and therefore appropriate behaviors are expected. Volunteers will adhere to ISPE policies, procedures, guidelines, and the Volunteer Code of Conduct in all interactions with other Volunteers, stakeholders, staff, vendors, and other constituents.

5. Volunteers do not have direct authority over staff and do not have authority to delegate actions to staff without the approval of the appropriate ISPE manager.

Avoiding Conflict of Interest

1. No Volunteer will use any information provided by the Society or acquired as a consequence of the Volunteer s service to the Society in any manner other than in furtherance of his or her volunteer duties. Furthermore, Volunteers will not misuse Society property or resources. They will at all times keep the Society s property secure and will not allow any person access to such property unless authorized by ISPE.

2. Volunteers will not persuade or attempt to persuade any Member, exhibitor, sponsor, supplier, contractor, or any other person/entity with an actual or potential relationship with the Society to terminate, curtail or not enter into that relationship. Further, Volunteers will not take any action that would serve to reduce the monetary or other benefits to ISPE of such relationship(s).

3. Volunteers are expected to act at all times in the best interest of the Society and not for personal or third-party enrichment.

4. When encountering a potential conflict of interest, Volunteers will identify the conflict and report it to the staff member assigned to the committee or project. If an actual conflict of interest is determined to exist, the Volunteer may be asked them to remove him- or herself from all discussions and voting on the matter.

5. Volunteers will not accept gifts, gratuities, free trips, honoraria, personal property, or any other item of value from any person or entity as a direct or indirect inducement to provide special treatment to such donor on matters pertaining to the Society without fully disclosing in advance such items to the staff member assigned to the committee or project.

6. Volunteers will not represent themselves as ambassadors, experts, or project leaders using ISPE s name in such a manner so as to imply or advance personal or company sales, leads or other gain.

Volunteer Commitments

1. Volunteers will carry out volunteer duties in accordance with ISPE procedures and adhere to project timelines to which they have agreed.

2. In the event that a Volunteer realizes that s/he cannot fulfill a commitment, s/he will notify the responsible staff project manager or volunteer leader proactively.

3. Volunteers will recognize and be respectful of the fact that staff project managers have deadlines and may on occasion find it necessary to replace or augment volunteer resources.

4. Volunteers will relinquish project responsibilities promptly when requested if doing so is deemed to be in the best interests of the Society.

Confidential Materials and Work in Progress

Upon termination of service, Volunteers will promptly return to the Society all documents, electronic and hard files, reference materials, and other property not already on file in the ISPE office. Such return will not abrogate him or her from the continuing obligations of confidentiality with respect to the information acquired as a

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consequence of his or her tenure as a Volunteer.

Violations of the Code of Conduct

ISPE staff will resolve any issues with Volunteers in a professional manner.

If issues or violations of the Code of Conduct are persistent or egregious, Volunteers may be required to leave their volunteer position(s) and may be precluded from serving in volunteer roles in the future. Except in cases pertaining to the Board of Directors, the CEO will determine if this action is necessary and will notify the Volunteer. In cases pertaining to the Board of Directors, the Executive Council will determine if this action is necessary and will designate one of its Members to notify the Board Member.

Non-Board Volunteers who have been removed from a volunteer position have 30 days to appeal the decision to the Executive Council of the Board. The Executive Council will review the situation and respond within 30 days of the request for appeal. All decisions of the Executive Council are final.

ISPE reserves the right to pursue additional measures up to and including legal action in extreme cases where the actions of a Volunteer may have compromised ISPE s mission, reputation, business prospects or legal stature.

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Volunteers will annually acknowledge compliance with this Code of Conduct by completing the appropriate consent form(s) as provided by ISPE staff

I have read the ISPE Volunteer Code of Conduct in its entirety and agree to abide by its provisions at all times while I am volunteering for ISPE.

Coordonnées
ISPE BELGIUM AFFILIATE VZW, AFGEKORT : ISPE …

Adresse
BREEVENSTRAAT 54 2880 BORNEM

Code postal : 2880
Localité : BORNEM
Commune : BORNEM
Province : Anvers
Région : Région flamande

ISPE BELGIUM AFFILIATE VZW, AFGEKORT : ISPE BELGIUM

Association sans but lucratif

Publication

Coordonnées ISPE BELGIUM AFFILIATE VZW, AFGEKORT : ISPE …

Coordonnées
ISPE BELGIUM AFFILIATE VZW, AFGEKORT : ISPE …