PART 1

Aim, Scope, Basis and Definitions

Aim

ARTICLE 1 – (1) The purpose of this Regulation is to regulate the procedures and principles regarding the aims, activities, managing bodies and duties of the managing bodies of Erciyes University Drug Research and Application Center.

Scope

ARTICLE 2 – (1) This Regulation covers the provisions regarding the aims, activities, managing bodies and duties of the managing bodies of Erciyes University Drug Research and Application Center.

Basis

ARTICLE 3 - (1) This Regulation has been prepared based on the sub-clause (2) of the clause (d) of the first paragraph of the Article 7 of the Higher Education Law dated 4/11/1981 and numbered 2547.

ARTICLE 4 – (1) Definitions of the following terms in this Regulation;

a) Advisory Board: Advisory Board of the Center,

b) Administrative Services Officer: The person responsible for administrative affairs in the center,

c) Quality Assurance Officer: The person responsible for the documentation of the projects in the center,

d) Center (ERFARMA): Erciyes University Drug Research and Application Center,

e) Sub-Units of the Center: Laboratory sub-units in the center,

f) Units of the Center: The laboratory units of the center,

g) Director: The Director of the Center,

h) Deputy Director: The Deputy Director of the Center,

ı) Rector: Rector of Erciyes University,

j) Vice-Rector: The Vice-Rector assigned to the Advisory Board of the Center,

k) University: Erciyes University,

l) Administrative Board: Administrative Board of the Center

PART 2

Aim and Fields of Activity of the Center

Aim of the Center

ARTICLE 5 – (1) The aim of the center is to coordinate the research and development activities within the University in the field of basic and applied sciences related to the pharmaceuticals and to obtain production-oriented results from these activities, to carry out basic researches required by the pharmaceutical industry for human, veterinary, agricultural and environmental health, and to perform services regarded as necessary regarding the subject within the framework of the legislation.

Fields of activity
ARTICLE 6 –   (1) The Center carries out the following activities in order to achieve its objectives:

a) To carry out scientific researches in all application areas related to drug research and development for human, veterinary, agricultural and environmental health, to develop new techniques, to prepare projects related to the problems of public and private enterprises, to give scientific reports, to help in solving technical problems, and to carry out technical consultancy services on developing new products, technology transfer and quality improvement.

b) To encourage, support and coordinate scientific and technical researches and applications carried out in all application areas related to drug research and development in different units of the university.

c) To encourage the training of academic staff in the field of drug research-development and application at the university, to prepare the necessary environment and opportunities. d) To cooperate with relevant public and private research institutions in the country and abroad, to exchange information and to seek financial resources for high technology projects.

e) To determine the principles of supporting basic and applied research projects related to the fields of activity of the Center, to support and implement research projects that prioritize the needs of our country and region.

f) To contribute to the development of basic and applied sciences related to pharmaceuticals and to carry out researches in order to solve the basic science problems of the pharmaceutical industry, to seek for solutions to the basic and applied research problems that may be encountered in the future in the fields foreseen by the development plans.

g) To enable the research results to find an application area, to announce the research results in the industry, to make application plans when necessary, to determine the necessary equipment, systems and specifications for a new material, product or process to start production.

h) To provide training on the matters within the field of activity of the Center, to send staff abroad in order to improve their experience and knowledge, and to invite or accept staff from abroad for this purpose.

ı) To organize training programs, seminars, conferences, courses, national and international congresses in order to increase the production of knowledge on the matters within the field of activity of the Center and to train qualified manpower at different levels, to issue certificates related to these events when necessary, and to make publications related to activities.

j) To apply the rules of biosafety and bioethics on the matters within the field of activity of the Center.

k) To carry out other activities in accordance with the establishment purpose of the center and the aims and principles of the Higher Education Law.

PART 3

Managing Bodies, Units and Duties of the Center

ARTICLE 7 – (1) The managing bodies of the Center are as follows:

a) Director

b) Administrative Board

c) Advisory Board.

Director

ARTICLE 8 – (1) The Director is assigned by the Rector for a period of three years from among the faculty members working on drug research and development. He/She may be reassigned when his/her term expires, or he/she may be dismissed by the same procedure before his/her term expires.

(2) The duties of the Director are as follows:

a) To take and implement the necessary measures regarding the management and operation of the Center in line with its objectives.

b) To preside over the Administrative Board,

c) To implement the decisions of the Administrative Board.

d) To carry out the administrative affairs of the Center, to prepare the budget proposal and to present the decision of the Administrative Board on the budget to the Rectorate.

e) To regulate and supervise the activities of the units established within the Center.

f) To cooperate with relevant centers and organizations at home and abroad, to carry out joint projects and mutual assistance activities.

g) To prepare the annual activity report and to submit the activity report accepted by the Administrative Board to the Rectorate.

h) To take the necessary initiatives in order to develop the financial resources of the Center and to use them in the most appropriate way.

Deputy Directors

ARTICLE 9 – (1) Two deputy directors are assigned by the Rector, upon the recommendation of the Director, from among the faculty members working on drug research and development. The term of office of the Deputy Directors ends automatically when the term of office of the Director expires or when the Director leaves the office.

(2) The duties of the deputy directors are as follows:

a) To be responsible to the Director for the proper functioning of the units under their control, and to take and implement the necessary measures regarding these units.

b) To assist the Director in the fulfillment of the duties and responsibilities undertaken by the Director. c) To deputize for the Director when necessary. Administrative Board

ARTICLE 10 – (1) The Administrative Board consists of the Director and six members. The members are assigned by the Rector for a period of three years from among the faculty members interested in the fields of activity of the Center and from among the faculty members of the academic units benefiting from the Center. Members whose term expires can be reassigned.

(2) The Administrative Board convenes at least once a month upon the invitation of the Director. An extraordinary meeting can also be held within two days with the written application of the director or at least three members of the Administrative Board stating the agenda. The Administrative Board convenes with the absolute majority of the total number of members and the decisions are taken by the majority of the members attending the meeting. In case of the equality of votes, the majority is deemed to be achieved according to the casting vote of the Director.

(3) Deputy Directors may attend the Administrative Board meetings without the right to vote. Administrative services officer acts as the reporter of the Board.

(4) The duties of the Administrative Board are as follows:

a) To determine the working order of the center.

b) To take decisions regarding the management and studies of the Center, to examine and decide on the recommendations of the Director regarding the units to be established within the Center and the candidates to be assigned in these units.

c) To take decisions on application and research areas by evaluating the available opportunities.

d) To discuss and decide on the activity report prepared by the Director.

e) To determine the principles of copyright and patent rights related to researches and applications carried out within the scope of the activities of the Center, and the distribution and use of incomes in accordance with the relevant legislation.

f) To examine and decide on the program and budget proposals prepared by the Director.

g) To evaluate the recommendations of the Advisory Board.

h) To decide on the researches requiring the cooperation of the Center with different institutions and their opportunities and to present them to the Rectorate for the support of the relevant institution. Advisory Board

ARTICLE 11 – (1) Approved by the Rector for a period of three years with the recommendation of the Administrative Board, under the chairmanship of a Vice-Rector, assigned by the Rector, the Advisory Board, both from inside and outside the University, consists of at least seven people who are directly interested in scientific and technological researches and applications in the field of drug and whose knowledge and experience will be benefited from.

(2) The Advisory Board convenes at least once a year. However, the Vice-Rector, Director or the Administrative Board may ask the Advisory Board to attend an extraordinary meeting.

(3) The Advisory Board gives opinions and advice on matters related to the studies of the Center.

Quality Assurance Officer

ARTICLE 12 – (1) The quality assurance officer is assigned by the Rector for a period of three years upon the recommendation of the Director among the University personnel holding a quality assurance certificate related to drug researches. He/She may be reassigned when his/her term expires, or he/she may be dismissed by the same procedure before his/her term expires.

(2) The quality assurance officer is responsible for the Center's quality assurance and relevant documentation.

(3) He/She organizes the working team responsible for the control and documentation of the steps related to the quality assurance of all projects that are carried out and planned to be conducted, and submits them to the Director's approval.

ARTICLE 13 – (1) Administrative services officer is assigned by the Rector for a period of three years upon the recommendation of the Director from among the administrative staff members with managerial experience who graduate from the departments of business, economics or finance of the faculties and work at the University. He/She may be reassigned when his/her term expires, or he/she may be dismissed by the same procedure before his/her term expires.

(2) The administrative services officer is responsible to the Director for the working and control of the IT Department of the Center and other administrative and support staff.

Units and Their Tasks

ARTICLE 14 – (1) The center consists of five units: quality control, formulation, pharmacology, medicinal plant researches and toxicology.

(2) Upon the proposal of the Administrative Board and the approval of the Rector, new units and sub-units may be established.

PART 4

Miscellaneous and Final Provisions

Cases where there are no Provisions in the Regulation

ARTICLE 15 – (1) In cases where there are no provisions in this Regulation, the provisions of the Higher Education Law No. 2547 and the relevant legislation are applied.

ARTICLE 16 – (1) This Regulation enters into force on the date of its publication.

ARTICLE 17 – (1) The provisions of this regulation are executed by the Rector of Erciyes University.