Academic Year 2006/2007 and 2007-/2008. Director: Prof. Giuseppe Nisticò

Transcription

1 UNIVERSITY OF ROME TOR VERGATA SCHOOL OF MEDICINE AND SURGERY MASTER S DEGREE PROGRAM - LEVEL II in SCIENTIFIC AND REGULATORY ASSESSMENT OF NEW MEDICINES Academic Year 2006/2007 and 2007-/2008 Director: Prof. Giuseppe Nisticò The University of Rome Tor Vergata, in partnership with the Italian Drug Agency, has activated a Master s Degree Program level II in Scientific and Regulatory Assessment of New Medicines for and academic years. Lectures and exams will be held in English. DESCRIPTION The purpose of the program is to train graduates with different backgrounds towards new professions related to the field of scientific and regulatory assessment of new medicines in view of the requisites posed by the national and European regulatory governance. Today, competence in this field are required by national and regional healthcare authorities and by pharmaceutical companies. Given the increasing implementation of international policies during the last decade and the responsibilities assigned to the European Drug Agency (EMEA, London) in terms of centralized procedures, the need to provide further sharpening of the professional skills of graduates from specifically related fields has grown. In this respect, the program meets the demand for trained professionals able to make complex scientific and regulatory assessments and capable of working with experts from other disciplines. In particular, the scope of the program is to provide the graduates admitted to the course with an updated overview of the subject matter, not only in terms of the scientific aspects of the drug itself and novel therapies (pharmacogenomics, gene therapy, therapeutic implementation of stem cells etc.) but also in terms of regulatory concerns. The two-year program is organized in four modules (two per year) each lasting four months.the first module of the first and second year, will cover the scientific aspects of the various topics (e.g.: pre-clinical pharmacology, toxicology, clinical pharmacology, biotechnologies, etc.) while the second, will include a practical approach, when possible. The lectures will cover examples of assessment analyses of reports on classes of drugs already considered in the first module. Before discussing the final thesis the participants must have spent a six-month period in one of the European countries working for one or more Regulatory Authorities. Admission to the course through evaluation of titles. The Master starts in academic year (courses start on March 12 th 2007). AIMS The purpose of the program is to train specialized professionals with the following characteristics: 1. must be able to scientifically evaluate the reports proposed by the pharmaceutical industry (in terms of quality assessment, clinical and pre-clinical pharmacology, drug surveillance ) in view of novel drug registration and marketing; 2. evaluation and management of any type of regulatory dossiers and, in particular, those dealing with drug registration; 3. be familiar with the legal and economic national and international aspects related to drug registration policies and procedures governing the various regulatory steps involved in drug design and developmental process;

2 4. have the ability to run the interactions between the company involved in drug design and development and external institutions, in particular the interactions with the Healthcare Authorities, and viceversa; 5. must have a basic technical and scientific knowledge in the three areas of quality compliance: GMP, GLP and GCP. DIDACTICS Courses and exams will be held in English. The two-year program includes a six-month stage abroad; the program equals 60 credits. The academic activities include lectures, seminars, individual study programs, stages which will be in support of the students individual work and team projects. The didactic activities and exams are held at Villa Mondragone - Frascati (RM). APPLICATIONS The number of enrollments is set between 20 and 50 for The prospective graduate participant must have earned his/her degree in Chemistry and Pharmaceutical Technologies, Biological Sciences, Medicine and Surgery (according the old university regulatory system) or in Pharmaceutical and Medical Biotechnologies ( II level degree according to the new university regulatory system). Foreign graduate students who wish to enroll in this program must have their titles recognized. Academic titles obtained abroad must be legalized and accompanied by an official legal translation and a statement of comparative worth which must be obtained from the Italian Delegation in the country where the academic title was issued (see section below). Students cannot enroll in other academic programs, such as Ph.D., or any other academic program while attending this master. ENROLLMENT FEES The enrollment fee is 5.000,00 per year ( for the entire Master s program).upon enrollment a stamp tax of 14,62 must be paid. Candidates with proven disabilities equal to 66% are entitled to a total fee exemption except contribution of for the entire course. for a APPLICATION PROCEDURES In order to fill out the application form to participate to the entrance competition you must: 1. go to at any of the self-service locations found at the students secretariat of all schools or from your PC; click the following titles in this order: CONCORSI RICONOSCIMENTI SELEZIONI CONCORSI/RICONOSCIMENTI INIZIA LA PROCEDURA DI ISCRIZIONE AL CONCORSO CONCORSI CORSI DI PERFEZIONAMENTO, MASTER - FACOLTA DI MEDICINA E CHIRURGIA - Master in Valutazione Scientifica e Regolatoria di Nuovi Medicinali (Scientific and RegulatoryAssessment of New Medicines ) code: PVM. 2

3 2. at the end of electronic enrollment procedures, the system will visualize a CTRL code (you must take note of it before printing out your application). This code is your registration number which may turn out to be useful should any problems arise in terms of completing the application form. Deadline: December 31 st 2006 (the official date considered is the one shown by the postal stamp of the Office receiving the envelope). 3. Sign the form and hand it in or send it by registred mail before the deadline. You must also enclose: a personal declaration stating the attainment of your university degree; a detailed curriculum vitae, with your signature; a list of the scientific activity; any other title or copy of it which may evaluated for admission; any of the following Qualifications in English Language Competence (PET, Trinity, Cambridge, TOEFL) and mail to: Università degli Studi di Roma Tor Vergata -- Segreteria Corsi di Perfezionamento e Master universitari -- Via O. Raimondo, Rome I The official list of the winners will be posted at the Secretariat of the Master by January 31 st The official list of the winners may also be viewed by visiting the Web site: The winners of the entrance competition will have to complete the enrollment process on-line by February 15 th COMPLETION OF THE ENROLLMENT PROCEDURES The winners must: 1. go to at any of the self-service stands or PC and click I want to enroll and then by clicking, in the following order VOGLIO IMMATRICOLARMI HO SUPERATO IL TEST DI ACCESSO INIZIA LA PROCEDURA DI IMMATRICOLAZIONE -- CORSI DI PERFEZIONAMENTO E MASTER FACOLTA DI MEDICINA E CHIRURGIA ane then select Master in Valutazione Scientifica e Regolatoria di Nuovi Medicinali ( Scientific and Regulatory Assessment of New Medicines ); 2. fill out the form; at the end of electronic enrollment procedures, the system will visualize a CTRL code (you must take note of it before printing your application); in case of errors, one may select delete form and then you can start again. Do not keep the wrong version of the application form. 3. print out the application form and the fee payment form of 2.514,62 (which includes the tax stamp of 14.62); the fee payment form generated by the system is the only acceptable form. Any other form or amount is not accepted and will not be reimbursed. The fee may be paid at any branch of the BANCA DI ROMA on the Italian territory; 4. convalidate your payment on-line by entering the CTRL code and the AUTH code issued by the bank; this is a fundamental step. Press STAMPA : the system will generate a login id and a password which you must keep and use again when paying the remaining installments. Half of this receipt will be 3

4 handed in upon enrollment together with all the documents listed previously. This step may be repeated in case of error by selecting the option from the menu. NO APPLICATION WILL BE ACCEPTED WITHOUT THIS RECEIPT 5. Hand in or post by registred mail to:università degli Studi di Roma Tor Vergata -- Segreteria Corsi di Perfezionamento e Master universitari -- Via O. Raimondo, Rome I DEADLINE: February 15th 2007 Make sure to include: a print out of the application form the receipt of payment issued by the bank a photocopy of a valid ID convalidation of payment bearing the specification da consegnare in segreteria HOW TO PAY FOR THE SECOND INSTALLMENT Payment of the second installment ( 2.500,00) requires the same on-line procedure by clicking MI VOGLIO ISCRIVERE AGLI ANNI SUCCESSIVI O ACCEDERE AD ALTRI SERVIZI ; then digit your login id and password. After convalidating the payment, send, by registred mail, the original copy of your receipt to: Università degli Studi di Roma Tor Vergata -- Segreteria Corsi di Perfezionamento e Master universitari -- Via O. Raimondo, Rome I -- by June 15th Please note: you must convalidate on-line each installment of the fee otherwise you cannot continue the program. FOREIGN STUDENTS Foreign graduate students who wish to enroll in this program must have their titles recognized. Academic titles obtained abroad must be legalized and accompanied by a legal translation and a statement of worth which must be obtained from the Italian Delegation in the country where the academic title was issued. The foreign academic title/university degree must be attached to the application form together with its legal official translation into Italian, the legalization of the title statement of comparative worth issued by the local Italian Delegation where the title was earned. Original official Academic Record issued by the university where the degree was obtained Qualifications in English Language Competence (PET, Trinity, Cambridge, TOEFL) Non EC students residing abroad may apply through the local Italian Delegation Office; the office will then forward the application to the University, together with the original academic title obtained abroad accompanied by the official legal translation into Italian, official legalization and statement of worth. Non EC candidates residing abroad must also hand in the PERMESSO DI SOGGIORNO issued by the Questura which must be valid for at least a full year. Non EC candidates residing in Italy must also hand in: the PERMESSO DI SOGGIORNO specifying the reason for the issuing (selfemployed, employed by others, family reasons, political asylum, humanitarian asylum or religious reasons) CERTIFICATO DI RESIDENZA 4

5 ENROLLMENT SECOND YEAR Only those students who have passed all the first year requirements may enroll in the second year. This can be done through the on-line procedures previously described. Start by clicking MI VOGLIO ISCRIVERE AGLI ANNI SUCCESSIVI O ACCEDERE AD ALTRI SERVIZI. Digit your login in id and password etc. The enrollment application form must be sent, together with the receipt of payment (Euro 2,514.62, stamp tax included) convalidated on-line, to: Università degli Studi di Roma Tor Vergata -- Segreteria Corsi di Perfezionamento e Master universitari -- Via O. Raimondo, Rome I The deadline is November 28 th The payment of the second installment of the second year must follow the same iter. The deadline is June 6 th Incomplete applications will be disregarded. ATTAINMENT OF THE TITLE The participants who will have passed the tests and the final examination will receive the title of Master s Degree - Level II in Scientific and Regulatory Assessment of New Medicines. In order to receive the final diploma, the student must fill out a request and payment form of 100,00, unless the charge is modified by the Board of Directors. The payment form can be downloaded from by clicking AMMINISTRAZIONE and then by selecting STAMPA PERGAMENE : print the attach to contents. The request and the receipt of payment must be handed in or sent by registred mail to: Università degli Studi di Roma Tor Vergata -- Segreteria Corsi di Perfezionamento e Master universitari -- Via O. Raimondo, Rome I INFORMATION Segreteria Corsi di Perfezionamento e Master universitari -- Via O. Raimondo, Rome I opening hours: MONDAY and FRIDAY 9:00-12:00 WEDNESDAYS 9:00-12:00 and 15:00-17:00 The application form together with the documents required may also be sent, by registred mail, to the Director of the European School at the following address: Prof. Giuseppe Nisticò European School for the Scientific and Regulatory Assessment of New Medicines Villa Mondragone Congress Center Via Frascati, Monte Porzio Catone (RM) Italy Administrative Director Dott. Ernesto Nicolai The President Prof. Alessandro Finazzi Agrò 5

6 Date: September 8th