ORGANIZATION
ORGANIZATION CHART
AFA is functionally structured based on the following chart:
The organization and division of responsibilities are established in the charter of the Association. According to the charter, the Assembly is the Association governing body, and therefore the highest decision–making part. The Board of Directors manages the Association based on what is approved by the Assembly. The Executive Management of the Association follows the guidelines from the Board of Directors, managing the activities performed by AFA.
The organization of audits is regulated by the
Intercompany Protocol. This document constitutes the AFA regulations to develop joint programmes for the validation of suppliers and manufactures, which is one of the key activities to guarantee that the audit activities are performed with the quality, rigor and excellence required by the associates and following the Health Authorities guidelines.
The
Intercompany Protocol regulates among others the following aspects:
• Collaboration Scope
• Confidential Disclosure Agreements (CDAs) between affiliates, auditors and auditees
• Auditors profile
• Absence of conflict of interest
• Audit planning
• Acceptance criteria
• Evaluation of criticality of supply
• Audits Methodology
• Audit Reports
• Audit follow-up
• Supplier / Manufacturer Final Evaluation
GENERAL ASSEMBLY
The Assembly is the highest decision-making body of the sovereign Association and is comprised by representatives of the affiliated companies.
In order to become an
affiliate member, the company must be a
Marketing Authorization Holder (MAH) or Manufacturing Authorization Holder of Pharmaceutical, Veterinary, cosmetic or similar products. Besides, the Association charter and the Intercompany Protocol must be approved and the membership fee paid.
The General Assembly is the governing body of the Association. It has the following responsibilities, among others:
Electing the members of the governing body and managing the AFA activities..
Approval of the annual budget and the annual accounts liquidation.
Join others associations.
Agree on members’ disenrollment.
The Assembly meets in ordinary session at least once a year.
All agreements are taken by simple majority and the election of the Board of Directors is performed by relative majority.
In the present mandate the Board of Directors is composed by: Dr. Octavi Colomina (President), Dr. Eduard Cayón (Vice-President and Treasurer), Mr. José Maria Giménez Alcover (Secretary).
BOARD OF DIRECTORS
The AFA Board of Directors, governs, manages and represents the Association, having the following responsibilities, among others:
Representing, leading and managing the Association
Executing and complying with the decisions taken by the General Assembly
Convening General Assembly meetings
Establishing working groups
It is composed by:
President: Dr. Octavi Colomina
Ph.D. in Chemical Engineering and BSc. in Chemistry.
More than 28 years of professional experience in the fields of Biochemical Research, Petrochemical & Fine Chemical Industry, Software Development and Project Management for Computer System implementation within the Pharmaceutical and Chemical industry fields. Since 1994, he works as a Pharmaceutical industry Consultant in Spain and several European countries being involved in technical projects and regulatory compliance for the Chemical, Pharmaceutical, Veterinary and Cosmetic industries.
Vice-President and Treasurer: Dr. Eduard Cayón
Ph.D. in Chemical Science. More than 20 year professional experience developed in Chemical Research, Pharmaceutical Analytical Development, Pharmaceutical and Food Quality Control, Validation, Auditing and Quality Assurance for the Pharmaceutical industry. Since 1999, he works as a Pharmaceutical industry Consultant in Spain and several European countries being involved in technical projects and regulatory compliance for the Pharmaceutical, Chemical and Cosmetic industries. He has performed more that 120 audits to Pharmaceutical industry suppliers.
Secretary: Sr. José María Giménez-Alcover
BSc. in Law by the Universidad Central de Barcelona. Law firm owner. Member # 11.916 from the Ilustre Colegio de Abogados de Barcelona. Specialized in Civil, commercial, Insolvency, Family and Procedural Law. He worked as a Professor of International Law at the Universidad Internacional de Catalunya and as lawyer for the Real Canal de la Infanta. He is one of the founders of AFA and is a member of the Grupo Jurídico Gispert where he manages the Payment Procedure, Enforcement orders, Mortgage Prosecution Department
EXECUTIVE MANAGEMENT
The Executive management follows the guidelines from the Board of Directors in the management and administration of AFA.
The Executive Management position is hold by Dr. Eduard Cayón, a member of the Board of Directors (Vice-President and Treasurer).