Actualización de Legislación Farmacéutica 24 al 28 de Marzo de 2014

AEMPS – MINISTERIO DE SANIDAD

25/03/14 Actualización de la Solicitud de certificados de

cosméticos (versión 2)

Relación informativa de medicamentos afectados por las deducciones establecidas en el

Real Decreto Ley 8/2010 de 20 de Mayo por el que se adoptan medidas extraordinarias para la reducción del déficit público: Abril 2014;

http://www.msssi.gob.es/profesionales/farmacia/notasInfor.htm Listado de agrupaciones homogéneas de medicamentos y precios menores - Abril

2014

COMISIÓN EUROPEA 28/03/2014 Revision of the Guideline on the format and content of applications for designation as orphan medicinal products

On 28 March, the European Commission published the revised EU guideline on the format and content of applications for designation as orphan medicinal products and on the transfer of designations from one

sponsor to another (85 KB). The European Commission reviewed the guideline to clarify how sponsors

should define the medical plausibly of their product in relation to a disease and its significant benefit. In addition, the electronic submission of an application using the common Food and Drug Administration-European Medicines Agency application form will be possible. During the development of the product, the classification of a disease may change and the designated condition may need to be modified to better reflect the indication that the sponsor intends to request at the time of marketing, therefore, an existing designation can now be amended.

EMA

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/landing/whats_new.jsp&mid=WC0b01ac058004d5c4

28/03/2014 Joint European Medicines Agency (EMA), US Food and Drug Administration

(FDA), and Japanese Ministry of Health, Labour and Welfare (MHLW) and

Pharmaceuticals and Medical Devices Agency (PMDA) orphan medicinal product

workshop, European Medicines Agency, London, UK, From: 10-Mar-2014, To:

10-Mar-2014(updated)

28/03/2014 Public bulletin: Veterinary pharmacovigilance 2013

28/03/2014 Agenda: Agenda - COMP agenda of the 8-9 April 2014 meeting

27/03/2014 MRL report: Tildipirosin (bovine, caprine and porcine species): European public

maximum-residue-limit assessment report (EPMAR) - CVMP

27/03/2014 MRL report: Triptorelin acetate (all food producing species): European public

maximum-residue-limit assessment report (EPMAR) - CVMP

27/03/2014 Report: Assessment report for Article-5(3) procedure: Propylene glycol in

medicinal products for children

26/03/2014 Work instructions for additional administrative actions for veterinary medicines

arising during the preparation of Innovation Task Force briefing meetings in line

with SOP/H/3044

26/03/2014 PDCO monthly report of opinions on paediatric investigation plans and other

activities 19-21 March 2014

26/03/2014 European Medicines Agency/International Federation for Animal Health Europe

info day 2014, European Medicines Agency, London, UK, From: 13-Mar-2014,

To: 14-Mar-2014 (updated)

26/03/2014 Current tenders for €60,000 or more (updated)

26/03/2014 News and press releases: EMA reorganisation: changes to handling of certain

evaluation procedures for human medicines to be introduced from 1 April 2014

26/03/2014 List of medicinal products under additional monitoring (updated)

26/03/2014 List of medicinal products under additional monitoring (updated)

26/03/2014 Sixth annual workshop on the European Network of Paediatric Research at the

European Medicines Agency (Enpr-EMA), European Medicines Agency, London,

UK, From: 26-Jun-2014, To: 27-Jun-2014

25/03/2014 6th ICH E2B (R3) Individual Case Safety Report (ICSR) information day,

European Medicines Agency, London, UK, From: 13-May-2014, To: 13-May-

2014

25/03/2014 Revised rules of procedure of the Management Board

25/03/2014 Summary of transfer of appropriations in the budget 2013 25 March 2014

25/03/2014 Decision on amending budget No 1-2014

25/03/2014 Agenda: Agenda for the 83rd meeting of the Management Board(updated)

25/03/2014 Outcome of written procedures finalised during the period from 22 November

2013 to 21 February 2014

25/03/2014 Rules for the implementation of Council Regulation (EC) No 297/95 on fees

payable to the European Medicines Agency and other measures - Revised

implementing rules to the Fee Regulation as of 1 April 2014

25/03/2014 Implementing rules to the Financial Regulation applicable to the budget of the

European Medicines Agency

25/03/2014 Overview of Staff Regulation implementing rules signed by the Management

Board Chair during the period from 16 November 2012 to 26 February 2014

25/03/2014 Minutes of the CHMP meeting 17-20 February 2014

25/03/2014 PRAC recommendations on signals adopted at the PRAC meeting of 3-6 March

2014

25/03/2014 List of signals discussed at the PRAC since September 2012(updated)

25/03/2014 Scientific guideline: Concept paper on the revision of the guideline on

immunogenicity assessment of biotechnology-derived therapeutic proteins,

draft: consultation open

24/03/2014 EU Telematics highlights 2013 - Implementation of the new EU Telematics

governance

24/03/2014 The joint European Union Telematics governance model (updated)

24/03/2014 Information Technology Directors Group - List of nominated members

(alphabetically by country) (updated)

24/03/2014 Minutes of the CAT meeting 13-14 February 2014

24/03/2014 Working for the European Medicines Agency (updated)

24/03/2014 Careers (updated)

24/03/2014 Guidelines and concept papers adopted at the CHMP meeting 17-20 March 2014

24/03/2014 Agenda: Agenda - HMPC agenda of the 24-25 March 2014 meeting

24/03/2014 Organisational matters: CHMP meeting of 17-20 March 2014

24/03/2014 Opinions on safety variations / periodic safety update reports adopted at the

CHMP meeting 17-20 March 2014

24/03/2014 Opinions on annual re-assessments, renewals of marketing authorisations and

accelerated assessment procedures adopted at the CHMP meeting 17-20 March

2014

24/03/2014 Work plan for the CVMP Efficacy Working Party 2014 (updated)

24/03/2014 Work plan for the CVMP Safety Working Party 2014 (updated)

24/03/2014 Work plan for the joint CVMP/ CHMP ad-hoc expert group on the application

of the 3Rs (replacement, reduction and refinement) in regulatory testing of

medicinal products (JEG 3Rs) (updated)

24/03/2014 Scientific guideline: Draft concept paper for a guideline on user safety of

topically administered products, draft: consultation open

24/03/2014 CAT monthly report of application procedures, guidelines and related

documents on advanced therapies: March 2014 meeting

24/03/2014 Report: Medicinal products for human use: Monthly figures - February 2014

24/03/2014 News and press releases: European Medicines Agency’s Management Board

endorses revised policy on handling of declarations of interests

24/03/2014 Release of data from clinical trials (updated)

CMDh http://www.hma.eu/186.html

25 March 2014

NEW - Report from meeting held on 17-19 March 2014

Otra Información Documentos de interés IMS HEALTH:

- THE GLOBAL USE OF MEDICINES: OUTLOOK THROUGH 2017

- RIDING THE INFORMATION TECHNOLOGY WAVE IN LIFE SCIENCES: PRIORITIES,

PITFALLS AND PROMISE

Actualización de Legislación Farmacéutica 31 de Marzo al 4 de Abril 2014

AEMPS – MINISTERIO DE SANIDAD

04/04/14 Boletín anual de Farmacovigilancia

Veterinaria - Año 2013

02/04/14 Nuevo sistema de codificación de las facturas Nota Informativa SG, 2 /2014

01/04/14 Nota informativa de la 2ª reunión del Comité de Disponibilidad de Medicamentos Veterinarios, celebrada el 27 de marzo de 2014. Nota informativa MVET (CODI-VET), 1/2014

Medicamentos genéricos con resolución de precio y financiación de la D.G. de Cartera de Servicios del SNS y Farmacia: Marzo 2014

http://www.mspsi.es/profesionales/farmacia/financiacion/GenericosAno2014.htm

EMA

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/landing/whats_new.jsp&mid=WC0b01ac058004d5c4

04/04/2014 News and press releases: World Health Day 2014: focus on diseases transmitted by vectors

04/04/2014 Newsletter: Human medicines highlights - March 2014

04/04/2014

Questions and answers relating to open tender procedure – EMA/2014/01/PH Monitoring of scientific and medical literature and the entry of relevant information into EudraVigilance

04/04/2014 EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD)

organisations (updated)

04/04/2014 Presubmission request form (updated)

04/04/2014 Regulatory and procedural guideline: Dossier requirements for centrally

authorised products (updated)

04/04/2014 EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD)

pharmaceutical dose forms (updated)

04/04/2014 EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) routes

of administration (updated)

04/04/2014 List of European Union reference dates and frequency of submission of

periodic safety update reports (updated)

03/04/2014 News and press releases: EMA confirms withdrawal of two court cases

concerning access to clinical-trial data

03/04/2014

Joint European Medicines Agency (EMA), US Food and Drug

Administration (FDA), and Japanese Ministry of Health, Labour and

Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency

(PMDA) orphan medicinal product workshop, European Medicines Agency,

London, UK, From: 10-Mar-2014, To: 10-Mar-2014 (updated)

03/04/2014 Member States involved in the EMA-EU MSs-FDA initiative on inspections

for generic applications (updated)

03/04/2014 Minutes of the HMPC 27-28 January 2014 meeting

02/04/2014 Minutes - PDCO minutes of the 12-14 February 2014 meeting

01/04/2014 Regulatory and procedural guideline: Mock-ups checklist - Guidance for

checking mock-ups

01/04/2014 Q&A: 1-20 (updated)

01/04/2014

Regulatory and procedural guideline: The revised checking process of

mock-ups and specimens of outer/immediate labelling and package leaflets

in the centralised procedure for veterinary medicinal products, adopted

(updated)

01/04/2014 Q&A: Mock-ups (updated)

01/04/2014 Q&A: Extension applications (updated)

01/04/2014 News and press releases: European Medicines Agency introduces new fee

incentives for SMEs for post-authorisation activities

01/04/2014 Rules for the implementation of the financial regulation applicable to the

budget of the European Medicines Agency (updated)

01/04/2014

Commission Regulation (EU) No 272/2014 of 17 March 2014 amending

Council Regulation (EC) No 297/95 as regards the adjustment of the fees of

the European Medicines Agency to the inflation rate

01/04/2014 Explanatory note on fees payable to the European Medicines Agency

01/04/2014 News and press releases: Increased fees coming into effect on 1 April 2014

01/04/2014 Questions and answers relating to open procurement procedure

EMA/2014/05/COM – Information resources

01/04/2014 Use of eSubmission Gateway / Web Client extended to new procedure types

from 1st of April 2014

01/04/2014 Electronic submission of veterinary dossiers: Questions and answers

(updated)

01/04/2014 CHMP Blood Products Working Party work programme 2014 (updated)

01/04/2014 News and press releases: SME workshop on quality of medicines takes

place this Friday

01/04/2014 Type-IB variations: questions and answers (updated)

01/04/2014 Periodic safety update reports: questions and answers (updated)

01/04/2014 Transfer of marketing authorisation: questions and answers (updated)

01/04/2014 Article-61(3) notifications: questions and answers (updated)

01/04/2014

Regulatory and procedural guideline: European Medicines Agency post-

authorisation procedural advice for users of the centralised procedure:

document with track changes (updated)

01/04/2014 Type-II variations: questions and answers (updated)

01/04/2014 Type-IA variations: questions and answers (updated)

01/04/2014 Regulatory and procedural guideline: European Medicines Agency post-

authorisation procedural advice for users of the centralised procedure

(updated)

CMDh http://www.hma.eu/186.html

1 April 2014

NEW - Summary PSUR Assessment Reports for ketoprofen (except topical use),

nortriptyline, rabbit anti-human thymocyte immunoglobulin, sodium iodine

(1231) and technetium (99mTc) exametazime

NEW - Article 45 and Article 46 of the Paediatric Regulation - Combined Public

Assessment Report for gadopentenate

UPDATE - List of active substances included in work-sharing procedure in

accordance with Article 45 of the Paediatric Regulation

UPDATE - Data requested for Variations and/or Renewal Applications in the

MRP/DCP

UPDATE - Question and Answers on Variations

UPDATE - Mandate for CMDh Working Party on Harmonisation of SmPCs

UPDATE - Information on applications referred to CMDh in accordance with

Article 29(1) of Directive 2001/83/EC

UPDATE - List of substances under PSUR Work sharing scheme and other

substances contained in Nationally Authorised Products with DLP synchronised

Otra Información

1. Proyecto de ley sobre la publicación obligatoria de los resultados de los EC. Se adjunta

la nota de prensa publicada por el PARLAMENTO EUROPEO: http://www.europarl.europa.eu/pdfs/news/expert/infopress/20140331IPR41186/20140331IPR41186_es.pdf

2. Boletín de PHAR-QA (ver Anexo)

This newsletter is dedicated to the memory of the late Bart Rombaut.

Bart Rombaut. 19th January 1958 – 23rd January 2014.

Bart passed away towards the end of January this year. I worked with Bart over very many years and will always remember his enthusiasm and good humour. He will be sorely missed by the members of the PHAR-QA project that he coordinated for all too short a time, and by the pharmaceutical community as a whole. Jeffrey Atkinson Executive director, PHAR-QA Passing Away of EAFP President, Professor Bart Rombaut Bart Rombaut, President of the European Association of Faculties of Pharmacy (EAFP) has passed away suddenly. Professor Rombaut has been active within EAFP since the foundation years of the Association. He served as Treasurer and in 2006 he was elected President. Bart Rombaut had a vision for the development of pharmacy education to prepare students both for the professional and scientific activities that are contemporary as well as for upcoming new demands and technologies. He was a driver for EAFP to take up a leadership role in the developments in pharmacy education and the profession at an international level. Bart Rombaut was successful to lead applications for EU-Funded Projects for EAFP and was instrumental in the projects namely PHARMINE, PHAR-QA and PHAR-IN. These projects are contributing to the development of pharmacy curricula in Europe and beyond. Bart Rombaut was Professor and Head of school of pharmacy at the Vrije University in Brussels (VUB). He was a true colleague and friend who will be sorely missed by his wife and son, EAFP members, colleagues at the VUB and the international pharmacy community. EAFP Executive Committee, 23 January 2014 EAFP Secretarial Office Lilian AZZOPARDI Department of Pharmacy, Faculty of Medicine and Surgery, University of Malta, Msida, MALTA Homage of Prof. Dr. Yvette Michotte during the farewell ceremony in the honour of Pr. Dr. Bart Rombaut – on the 1st of February 2014 - Vilvoorde Family, friends and colleagues of Bart, I speak to you in the name of the Rector of the “Vrije Universiteit Brussel” Prof. Paul De Knop, the Dean of the Faculty of Medicine and Pharmacy Prof. Alain Dupont and on behalf of all my fellow professors, assistants, researchers, administrative and technical staff of our Pharmaceutical Institute. Bart, the Pharmaceutical Institute was your favourite, your apple of the eye. The last 10 years you were there the father, the face and the inspirer of. Already since 2005, you were president of the Pharmaceutical Institute and the Chairman of the Educational Board of Pharmacy.

The PHAR-QA journal Since 2004, you were also the vice dean of the Faculty of Medicine and Pharmacy and mainly responsible for student and education related matters. Although your academic career at our university began as a research fellow of the Fund for Scientific Research, the focus on your academic career shifted slowly to teaching and research on educational innovation, implementation of new curricula primarily for the benefit of the programs within the pharmacy. The other programs of the Faculty could also count on your expertise. Your interest in education and educational support was again evident when you took charge of the Student Guidance Centre of the medical campus and together with the staff, who you often called “my girls", you have made it a success. For students in Pharmacy you were clearly the contact among the professors. You also represented our school of pharmacy in interuniversity consultation. Our alumni from the past 10 years will remember you as the director of the graduation ceremony and as the professor who spoke to the graduates and their parents and led everything run smoothly. Everyone noticed that you enjoyed these moments and that you were proud of your graduates. On information fairs you were always ready to provide information on the study of pharmacy for future students and their parents and you always managed to enthusiasm the visitors. You told us that you were a pharmacist in heart and soul and that you were very proud to be a pharmacist. You may have transferred that enthusiasm to your son Matthias who is now a student in the 2nd year Bachelor of Pharmacy. At national and international level, you had many contacts with professional associations and other universities. You were president of the European Association of Faculties of Pharmacy and a member of the Royal Pharmaceutical Academy of Spain. Together with international colleagues you defended the profession of community pharmacist and the role of the community pharmacist as an essential link in primary health care in Europe. You constantly campaigned for better education and appreciation of the community pharmacist. Proof of this is that you were the coordinator of several European LLP - Erasmus Projects, among others the PHARMINE project on Pharmacy Education in Europe. Within our educational board your constant concern for an excellent and innovative pharmacy education was obvious. You were also the coordinator of innovation projects within our educational programs. Only two weeks ago, you came to see me about a new initiative that you wanted to take, namely the creation of a new bachelor program in health care. You had expressed this idea many years ago, but now it was time to materialize this concept. You also maintained good relations with the Erasmus University College Brussels and more specifically with their departments on the medical campus of our university. You were in favour of collaboration between the two institutions and you committed yourself to this collaboration. Like I said, you started your career as a research fellow of the Fund for Scientific Research in 1981 after earning your degree in pharmacy at the Vrije Universiteit Brussel. You performed your doctoral research under the supervision of Prof. Emeritus Albert Boeye and you obtained your doctoral degree in Pharmaceutical Sciences in 1986 with a thesis entitled "Antigenicity and morphogenesis of poliovirus". In your further academic career virology remained your favourite research area and you remained intrigued by the poliovirus. You have made major scientific contributions to the unravelling of the structure of the poliovirus and the development of vaccines and antiviral substances. Evidence of this are your numerous publications in this field and recognition as an expert for the World Health Organization. You were also a member of numerous scientific societies for virology. In 1991 you became a lecturer and in 2010 you became full professor at the Faculty of Medicine and Pharmacy of the Vrije Universiteit Brussel. You were the chairman of the Department of Pharmaceutical Biotechnology and Molecular Biology.

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The PHAR-QA journal Since 2004, you were vice Dean of the Faculty of Medicine and Pharmacy. Since 2005 you were the President of the Pharmaceutical Institute. Since 2006 you were also coordinator of the inter-university Master in Hospital Pharmacy and between 2006 and 2010 you were visiting professor at the University of Nijmegen. Bart, your colleagues and students remain orphaned and will miss you. But your commitment to the Faculty, the Pharmaceutical Institute, the students, the pharmacy education and the profession will be guarded and cherished and be continued. This would certainly have been your wish. We wish Matthias, Pascale, your family and your loved ones a lot of strength and courage in this very difficult time. Deep in our hearts we will keep the memory of you and of all the beautiful moments together. As Gabriel Garcia Marquez said "Life is not what happened but what one remembers and how one remembers it." February 1, 2014 Prof. Dr. Yvette Michotte Head of Department "Pharmaceutical Chemistry, Drug Analysis and Drug Information, «Pharmaceutical Institute”, Faculty of Medicine and Pharmacy, Vice Rector for Education Policy, Vrije Universiteit Brussel.

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With the support of the Lifelong Learning programme of the European Union: 527194-LLP-1-2012-1-BE-ERASMUS-EMCR This project has been funded with support from the European Commission. This publication reflects the views only of the author.

The Commission cannot be held responsible for any use which may be made of the information contained therein.

The PHAR-QA newsletter

April, 2014 http://www.pharmine.org/PHAR-QA/

Quality Assurance in European Pharmacy Education and Training: the PHAR-QA project

Correspondence to: Jeffrey ATKINSON, Lorraine University, Pharmacolor Consultants Nancy, Villers, France jeffrey.atkinson@univ-lorraine.fr and http://pcn-consultants.com/

Contents. Partner 4: University of Athens Page 4 EAFP/PHAR-QA meeting, Ljubljana, Slovenia 24th May 2014 Page 7 The PHAR-QA survey Page 9

At the transition meeting on the 26th February 2014, it was decided that Kristien De Paepe from the Vrije Universiteit Brussel, Belgium will take over from the late Bart Rombaut as manager of PHAR-QA P1 and project coordinator.

Editorial Board Jeffrey ATKINSON, Lorraine University, Pharmacolor Consultants Nancy, Villers, France. Peep VESKI, University of Tartu, Estonia. Daisy VOLMER, University of Tartu, Estonia. Kristien, DE PAEPE, Vrije Universiteit Brussel, Belgium. Antonio Sanchez POZO, University of Grenada, Spain. Dimitrios REKKAS, National and Kapodistrian University Athens, Greece. Jouni HIRVONEN, University of Helsinki, Finland. Borut BOZIC, University of Ljubljana, Slovenia Agnieska SKOWRON, Jagiellonian University, Krakow, Poland. Constantin MIRCIOIU, Universitatea de Medicina si Farmacie "Carol Davila" Bucharest, Romania.

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The PHAR-QA journal

Professor P. MACHERAS Professor A-L. SKALTSOUNIS Professor D. REKKAS Pharmacy is one of the first scientific subjects taught at the University of Athens. On May 18th, 1835 by Royal Decree the "Theoretical and Practical Didactic Shop of Surgery, Medicine and Pharmacopoeia” was established in Athens and this was exactly two years prior to the actual inauguration of the University of Athens (May 3rd, 1837).

The first School of Pharmacy was established in 1843. The courses offered in three didactic semesters were: Physics, Chemistry, Physical History, Medical Subjects, Botany, Pharmacology, Toxicology and their laboratories. In 1905 the Department of Pharmacy became part of the School of Medicine until 1922, when it was affiliated to the School of Sciences under which auspices it remained until 1982. Since 1988 became an independent Faculty. Recently became part of the School of Health Sciences of the University of Athens along with Medicine, Dentistry and Nursing/

The first Chair was that of Pharmaceutical Chemistry. In 1932 Pharmacognosy was added and in 1979 Pharmaceutical Technology. Each Chair, now Division, operates as an umbrella-system which includes various fields of study.

The Faculty of Pharmacy is located at the University Campus of the University of Athens in buildings with a total surface area of approximately 8.500 m2. More than the one third of these has been allocated for lecture rooms and laboratories for the undergraduate students. The remainder is mainly research laboratories for the graduate students and the 43 teaching staff members. A 32-seat

multimedia centre is also available for the students giving them direct access to digital libraries.

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The PHAR-QA journal The Pharmacy degree is a five year undergraduate course curriculum. The five-year studies are divided in ten

semesters. The curriculum has courses which are either theoretical or include additional laboratory training. All courses are organized in semesters and each course taught within the semester has been assigned a number of

credits. The Faculty offers a total of 67 courses including compulsory, laboratory exercises and electives. The students should complete a 300 ECTS in order to obtain the final degree in Pharmacy. Some basic science courses are offered by the School of Sciences while the medical courses, are offered to the Pharmacy students by the School of Medicine. Within the five-year period, students are also required to complete their 12-months practical training according to the European Directive both in a community and hospital pharmacy in order to be eligible for the Pharmacy Board Examinations administered by the Ministry of Health. Only graduates who have

passed the Pharmacy Board Examinations are considered registered Pharmacists. Every academic year the Department of Pharmacy accepts after specific examinations around 150 undergraduate students. The Faculty offers MSc degrees in 3 areas of pharmaceutical sciences, i.e., chemistry and natural products, clinical pharmacy and industrial pharmacy under 6 different subheadings. Postgraduate Degree of Specialization (MSc) in the following fields: • Clinical Pharmacy • Synthetic Pharmaceutical Chemistry • Pharmaceutical Analysis - Quality Control • Pharmacognosy and Chemistry of Natural Products • Radiopharmaceutical Chemistry • Industrial Pharmacy The Program of Postgraduate Studies of the Faculty of Pharmacy also grants: Doctoral Degree in the Pharmaceutical Sciences. As of March 2013, the Faculty had 855 undergraduates, 131 graduates at the MSc level and 68 PhD students. During the last five years the faculty has granted 132 Master and 51 PhD degrees.

The faculty is a member of EAFP and has organized in Athens the 2002 annual conference, while it has been selected for the EAFP 2015 as well.

It is also very active in the Erasmus program for students exchange and teaching staff mobility with more than 30 agreements with European Universities. The research activities cover a wide spectrum of disciplines such as: Pharmaceutical Chemistry, Pharmaceutical Analysis, Pharmacognosy and Chemistry of Natural Products, Pharmaceutical Technology, Bio-pharmaceutics / Pharmacokinetics, Pharmacology and Clinical Pharmacy. Total funding from competitive research programs from 2005-2013 was approx. 9 million Euros. Among them two LIFE projects were listed in the top 20 for 2005 and in the top 5 for 2008.

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The PHAR-QA journal The research output is considered quite impressive as during the last five years there are more than 500 publications from the faculty, receiving approximately 15,200 citations. The Faculty of Pharmacy Univ. of Athens is ranked within the first 170 for 2014 http://www.topuniversities.com/ During the second semester of 2013 the Department of Pharmacy, University of Athens completed its external evaluation successfully. The relevant final report was concluded on 20/08/2013 and became publicly available in English at the site of the Hellenic Quality Assurance and Accreditation Agency (http://www.hqaa.gr/). The external evaluation was carried out by four professors, two from US, one from Canada and one from Switzerland who after four days on site visit, which covered all aspects of the Faculty operation at every level, prepared and submitted their 25 pages report to the HQAA. From this report please find below a selection of some conclusive points: • Teaching remains a cornerstone of the Department and is viewed as being overall very good. • The objectives and contents of the curriculum of each of these degrees are adapted to the specific needs of the

area and to the professional requirements. The Department has in its ranks appropriately qualified scientific personnel to fully cover the teaching needs of the MSc degrees and the result fulfills universally accepted standards.

• The Department runs an excellent doctoral program producing high quality research results and has good

international reputation. • The mobility of academic staff and students is excellent and appropriately organized. There is a standing

committee for the SOCRATES-ERASMUS program for excellent students to be exposed to outside learning and research experiences.

• Research is an area of excellence of the Department. During the last decade a remarkable growth in terms of

peer-review publications and research funds has been noted. The EEC applauds the current efforts of the Department fully understanding that, at times, these research activities are accomplished under suboptimal conditions. Nonetheless, faculty members of the Department through tireless and valiant efforts have secured considerable funding for research and published research findings of high quality in peer-reviewed journals. Grants and peer-review publications, two common indices, are used by the Department to assess success in research. Secondary indices include noteworthy awards, organization of national and international meetings as well as memberships in editorial boards and scientific societies.

• The Department of Pharmacy is nationally and internationally recognized. This has been achieved by excellence

in research and high quality of education. The Department developed a broad range of graduate programs covering all aspects of pharmaceutical sciences. There is a high success of job placement after completion of the MSc degrees. An excellent doctoral program producing high quality research is in operation. The quality and number of scientific publications is excellent and places the Department among the top 100 departments of pharmacy and pharmacology in the world. The Department has attracted substantial funding from European sources. The Department has established a respected network of international collaborations.

All of the above constitute tremendous assets and a showcase for the success of the Department.

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PHAR-QA M20 meeting will be held jointly with EAFP conference in Ljubljana on May 24th 2014. The main topics presented will be the preliminary data of IMP DELPHI network and the EXP consultancy agency.

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The European network evaluation of the PHAR-QA framework of competences for pharmacists. The PHAR-QA (“Quality assurance in European pharmacy education and training”) funded by the European Commission, will produce a framework of competences for pharmacy practice and a quality assurance system to back this up. The PHAR-QA competence framework is primarily in line with the EU directive on the sectoral profession of pharmacy but also takes into account the diversity of the pharmacy profession and the on-going changes in European healthcare systems (with an increasingly important role for pharmacists), and in the pharmaceutical/biotechnological industry. Changes in the European Higher Education Area, especially those involving the bachelor and master degree organisation are also considered. You are asked to rank the importance of the competences bearing in mind that fact that this survey applies to the wide range of domains of pharmaceutical activity. Responders should concentrate on competences needed for all pharmacists - not only on those for their speciality. It also applies to Europe - minor differences in different countries should not be stressed. Following analysis of your replies, a second version will be produced for your evaluation. Following refinement of the framework via this repetitive Delphi process, a final version will be produced. This will form the basis of the PHAR-QA quality assurance system. The survey is available at:

https://www.surveymonkey.com/s/pharqasurvey1

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