Key Benefits:
Minister of Social Affairs and Health and Minister of Decentralization, State Reform and Public Service,
Vu la Act No. 83-634 of 13 July 1983 amendments to the rights and obligations of civil servants, together with Act No. 84-16 of 11 January 1984 amended with statutory provisions relating to the public service of the State;
Vu le Decree No. 92-1432 of 30 December 1992 amended on the special status of pharmacists in public health inspectors;
Vu le Decree No. 2004-1105 of 19 October 2004 concerning the opening of recruitment procedures in the public service of the State;
Vu le Decree No. 2007-196 of 13 February 2007 relating to the equivalences of diplomas required to present themselves to the public service access competitions and employment frameworks;
In view of the decision of 10 October 2001 establishing the organization and program of competitive examinations for pharmacists in public health inspectors,
Stop:
The first paragraph of paragraph II of Article 1 of the above-mentioned Order of 10 October 2001 is replaced by the following provisions:
1. Test consisting of an interview with the jury to assess the qualities of reflection, training and, if applicable, the achievements of the candidate's experience and his motivations. To conduct this interview, which has as its starting point a presentation of the candidate on his training and, if necessary, on his or her professional experience of not more than 10 minutes, the jury shall have the written and detailed presentation of the professional activities and scientific titles and work of the candidate constituted by the candidate according to the file model established by the administration. Only the interview with the jury gives rise to notation. The file is not noted (duration: 30 minutes; coefficient 4).
For this event, the candidate prepares a presentation file for his or her career path that he or she gives to the organizer at a date fixed in the opening of the contest. The relevant information to meet the requirements of this test is annexed to this Order.
The file is forwarded to the jury by the competition manager after the establishment of the eligibility list.
The file template is available on the Ministry of Social Affairs and Health website: http:// www. sante. gouv. fr, section "Les Métiers et concours". "
Article 2 of the same order is thus written:
"The jury, appointed by the Minister for Health, includes:
– the Director General of Health or his representative, President;
– the head of the general inspection of social affairs or his representative;
– the Director General of the National Drug and Health Products Safety Agency or its representative;
– the director of the School of High Studies in Public Health or its representative;
a Director General of Regional Health Agency or his representative;
a professor of a pharmacy training and research unit;
– two pharmacists public health inspectors in the regional health agencies.
In addition, there are several specialised examiners for the foreign language test. These examiners have no deliberate voice. »
Article 3 of the same order is thus written:
"The contests established in section 6 of the above-mentioned decree of 30 December 1992 are opened by order of the Minister for Health. »
Section 4 of the same order is amended to read:
"Applications must include a copy of the certificates, titles and diplomas required to compete. »
Section 5 of the same order is amended to read:
"A rating of 0 to 20 is assigned to each of the tests. Only candidates who have obtained a grade of at least 5 at each of the eligibility tests may be allowed to attend oral examinations and, for all of these tests, a total of at least 50 points after applying the coefficients.
No one may be declared admitted if he has not obtained a total of 140 points for all eligibility and admission tests after applying the coefficients.
The jury shall establish for each competition, in order of merit and within the limits of the positions offered, the list of candidates definitively admitted and, where appropriate, a supplementary list.
If several candidates meet the same number of points, priority is given to the one who obtained the best grade at the first oral admission test. »
The schedule of the same order shall be replaced by the provisions set out in Annex I to this Order.
The Director of Human Resources is responsible for the execution of this Order, which will be published in the Official Journal of the French Republic.
A N N E X E S
A N N E X E I
PROGRAMME OF REFERENCES
PUBLIC HEALTH INSPECTERS
Public Health and Environmental Science
1. Basic legal concepts:
General sources of national law (laws, regulations, jurisprudence) and supranational (community sources, treaties, regulations, guidelines, conventions);
Special source: pharmaceutical ethics;
Main rules for the care of medicines by health insurance (Public Health Code and Social Security Code).
2. Health system:
2.1. Institutional environment, health administration:
European Forums, Ministry of Health, National Health Agencies and National Public Health Institutions, Regional Health Agencies, OMEDIT, High Health Authority – Definitions and Skills.
2.2. Social and complementary security organizations.
2.3. Health professions within the meaning of Public Health Code conditions and conditions of their exercise:
Medical Professions, Pharmaceutical Professions ― Place and Role of Different Actors of the System: Health Professions, Medical-Social Institutions, Prevention, Social Coverage Organizations, Professional Representative Authorities (URPS).
2.4. The National College of Pharmacists and the Code of Ethics.
2.5. Inspection in health and medical-social areas: missions, areas of intervention, prerogatives.
3. Health products:
3.1. Drugs:
definitions and different categories, pharmacopoeia;
– pharmaceutical preparations and general principles of their good preparation practices;
– authorization to market drugs (MMA);
- herbal medicines;
- blood-based medicines;
veterinary medicine.
3.2. The raw materials for pharmaceutical use:
definitions and different categories;
- conditions for authorization or reporting of manufacturing, import and distribution activities.
3.3. The poisonous substances:
– definitions and different categories.
3.4. Conditions for the issuance and dispensation of drugs subject to the regulation of poisonous substances.
3.5. Medical devices and in vitro diagnostic medical devices:
definitions, different classes;
- conditions of marketing, CE marking;
― sterilization of DM ― quality assurance (good hospital pharmacy practices, guideline 1);
- legal regime.
3.6. Other regulated pharmaceutical products and substances.
4. Health product distribution circuits:
4.1. The pharmaceutical act and the pharmaceutical monopoly:
definition and limitations of monopoly;
- exemptions and sanctions;
- act of dispensation;
- pharmaceutical responsibility;
– medicines versus food supplements and border products;
– medicines versus other regulated products ( cosmetics, DM).
4.2. Pharmaceutical establishments and exercise of the pharmacist profession:
― definitions, different categories and conditions of opening, modification and operation;
manufacturing of medicines and general principles of their good manufacturing practices;
― wholesale distribution of medicines and general principles of their good wholesale distribution practices.
4.3. Pharmaceutical officers and other structures authorized to provide detailed medicines:
― definitions, different categories, opening conditions (creation, acquisition, transfer), minimum installation, operating conditions;
- missions of the pharmacist.
4.4. Pharmacies for domestic use in public and private health and medical and social facilities (EHPAD in particular):
Definitions, different categories and conditions of openness and operation, securing the circuits of medications (and medical devices). For health establishments: contract of good use management of the quality of medication management, therapeutic booklet.
4.5. Pharmacovigilance and other vigilances: definitions, organizations.
4.6. Advertising: key health product rules.
5. Medical Biology:
- definition and general principles;
organization;
― medical biology laboratories:
- legal regime of laboratories;
- conditions for the exercise of medical biologists;
quality, accreditation.
6. Health, society and environment:
6.1. General notes:
health, public health, prevention, lifestyle, environment;
health professions and health education, therapeutic education: the role of pharmacist;
― epidemiological methodology and data collection system: clinical trials, vigilance, pharmaco-epidemiology.
6.2. Other concepts:
risk: transmissible and non-transmitted;
– risk management and quality, error management;
– risk factors, risk groups (s);
– epidemiology, public health indicators.
6.3. Addressing risks associated with natural or artificial disasters:
― role of regional health agencies, public health plans (channel, white plans, etc.).
7. Overview of major public health problems in the world and in France:
7.1. Diseases:
Infectious or parasitic, vascular diseases, cancers, accidents, digestive or respiratory diseases, sexually transmitted diseases, drug addictions, chronic diseases, etc.
7.2. Fight against risks.
Drug science: general concepts
Sort of medications in the body, pharmacokinetic:
- main steps: absorption, distribution, metabolism, elimination;
factors affecting the fate of active principles: physiological factors (age, pregnancy...), pathological conditions (renal failure, liver disease), associated medications;
- major pharmacokinetic parameters;
bioavailability, definition of bioequivalence;
―iatrogeny;
– principles of determination of drug dosages.
Medication mechanisms and procedures:
– liaison with cell sites: reconnaissance sites, receptors; characteristics of connections, ligands; agonists and antagonists: methods of study;
- mechanism of pharmacological responses induced by receptor activation: second messengers, ion transfers;
― general characteristics of induced pharmacological responses (in vitro, in vivo). Effect-dose curves, effective dose 50, active dose 50, minimum active dose areas under the curve;
– associations: antagonism, synergy, methods of study;
― variations in organism sensitivity to medications;
- principles of the evaluation of drug action. Method of carrying out pharmacological and therapeutic tests.
Toxicological study of the drug, clinical trials:
Medication safety assessment methods:
― before market authorization (MMA):
study protocols: single administration toxicity, repetitive administration toxicity, reproductive function study, genotoxicity, carcinogenicity, local toxicity;
skills and structures (good laboratory practices [BPL], good clinical practices [BPC]);
- regulation;
― after marketing authorization (MMA): importance of pharmacovigilance and pharmacoepidemiology.
Technical methods of forming and enhancing the drug:
– Pharmaceutical forms (allopathic and homeopathic), pathways of drug administration;
- excipients, additives and packaging materials;
- pharmaceutical operations (broying and spraying, powder mixtures, dissolution, dispersion, distillation, desiccation, filtration, granulation, sterilization);
― biological products-based forms: vaccines, immunoglobin; blood, substitutes and derivatives;
― design and production of the drug: design, prototype, industrial production/good manufacturing practices;
– control of in vitro bioavailability – study of bioequivalence.
Quality assurance of health products:
– principles of quality assurance;
- approaches to good practices in general: good manufacturing practices (GMP), good distribution practices, good internet dispensing practices, good preparation practices, etc.;
– notion of certification, accreditation.
A N N E X E I
DOSSIER MODEL FOR THE REALIZATION OF THE ENTRETIAN EPREUV
Candidates must submit a standard file based on a model established by the administration, consisting of the following entries:
identification of the candidate;
- initial, professional and continuing training;
professional path (job posts, main missions and activities);
―exposed to the achievements of the professional experience (the candidate will present the achievements of his/her professional experience in terms of the skills and abilities sought and his/her professional project), 2 pages maximum typed (Arial 11);
― description of a professional realization;
― Declaration on Honour.
Done on 10 April 2014.
Minister of Social Affairs
and Health,
For the Minister and by delegation:
Deputy Director
the management of resources,
the right of personnel
and Social Dialogue,
A. Gauthier
Minister of Decentralization,
of State Reform
and the Public Service,
For the Minister and by delegation:
Chief of the Policy Office
recruitment, training
and professionalization,
A. Baron
