SCHEME. International Master in Regulatory Sciences (IMRS) BACKGROUND

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1 SCHEME International Master in Regulatory Sciences (IMRS) Promoted by the Community of Mediterranean Universities (CMU), Ondokuz Mayis University (OMU, Turkey), Gianni Benzi Pharmacological Research Foundation (FGB, Italy) BACKGROUND Within the framework of the CMU-OMU Label Study Programme - collaboration between the Ondokuz Mayis University (OMU) and the Community of Mediterranean Universities (CMU) / Unesco Unitwin Chair - it has been decided to implement the International Master in Regulatory Sciences (IMRS) with also the collaboration of the Gianni Benzi Pharmacological Research Foundation (FGB). The purpose of this collaboration is to: - promote a deep knowledge of the Regulatory Sciences, recognised as a highly innovative sector; - foster the international cooperation as well as the economic, industrial and local Institutions development; - deliver the Study Programme concerned with the Higher Education courses in the Mediterranean Area; - promote the mobility of students and teachers; - create a multicultural learning and teaching environment and to enhance the intercultural dialogue; 1

2 - strengthen the basis for future cooperation within the project concerning Higher education and research programme on sustainable development in the Mediterranean region under the auspices of UNESCO and UNAI; - collaborate in implementing the UNESCO-Unitwin Mediterranean Chairs Network; - uphold the freedom of science and, therefore, to contribute to peace. WHY GENERAL DESCRIPTION Regulatory Sciences are a relative newly recognised scientific discipline aimed to discover, set up and continuously update procedures, tools, standards and approaches to more efficiently develop products for human use and to more effectively evaluate their safety, efficacy and quality. In the light of the rapid evolution of science and technology, the process of translating biological and biomedical discoveries into new therapies and products for human use has become increasingly complex and requires that the Regulatory Sciences keep up timely and effectively with the advancement in biomedical science and technology. In this context, the International Master in Regulatory Sciences (IMRS) aims at: promoting a common understanding and deep knowledge of the current main regulatory systems; creating or updating highly experienced professionals able to participate in the development, the validation and the marketing of products for human use and providing them with full and update knowledge at European/non-European level; fostering opportunities for cooperation activities; offering more job opportunities for younger people. TO WHOM IIMRS is devoted to young post-graduate students (Master s Degree) with no working experience who wish to become regulatory experts to be employed in the health care Industry, CROs, regulatory bodies and Agencies, Universities, higher education Institutions, research centres, public and private healthcare structures, Ministries of Health. 2

3 In particular, it is aimed to train and update a new generation of scientists in Regulatory Sciences, able to participate in the development, the validation and the marketing of products for human use, in order to identify and disseminate innovative solutions resulting in better-science based and faster regulatory decisions and approval processes. HOW The Master provides a wide didactic offer, with a complete course of 60 ECTS (European Credit Transfer and Accumulation System -ECTS, as a standard for comparing the study attainment and performance of students of higher education across the European Union) corresponding to 25 hours per Credit of student s workload (1.500 hours/year). The Master Programme is scheduled in 1500 hours, of which: 300 hours of front lecturing (corresponding to 12 ECTS) consisting of 120 hours of face to face lecturing (F2F), delivered in 3 didactic weeks and 180 hours of e-learning lectures that will be delivered in 3 months. The 300 hours of front lecturing also include 40 hours of laboratories during the F2F sessions and 60 hours of webinars, meeting professors through live streaming sessions during the e-learning sessions; 200 hours of training/exercises sessions (8 ECTS); 500 hours of stage/work placement (corresponding to 20 ECTS); 400 hours of self-learning (using the e-platform and corresponding to 16 ECTS); 100 hours for the preparation of the final thesis (corresponding to 4 ECTS). See Figure 1. describing scheduled activities: - Face to face lecturing (120 hrs) - Practical lab activities (40 hrs during the F2F lecturing) - Exercises (200 hours) - E-learning (180 hrs) - Self-learning (400 hrs) - Stage/work placement (500hrs) - Preparation of final dissertation (100 hrs) 3

4 Fig.1 IMRS educational activities In particular, the Master Programme is characterised by the following main subjects: human pharmacology, authorisation procedures on the national and international scenario, legal and regulatory requirements and controversies in different EU and non-eu countries (including regulatory guidelines and ICH), drug development process and plans, pharmacovigilance, toxicology and drug safety, environmental pharmacology food (development, Risk Analysis, Risk Assessment, Risk Management and Risk Communication) as well as Marketing Authorisation applications and dossiers. 4

5 EXPECTED OUTCOMES Students that successfully complete the program are awarded with a diploma in International Master in Regulatory Sciences (IMRS), compliant with the quality standards and the legal provisions of the European Community Masters, but also of any other participating Universities of the Mediterranean Area. The students should be able to: 1. Transfer knowledge and skills related to the Master, both written and oral. 2. Have clear attitude towards change and innovation. 3. Acquire ability for problem-solving and decision-making. 4. Attend cycle product management in the regulatory science field. 5. Acquire the necessary legal, economic and technical knowledge to be aware of the international and national rules governing the procedures for development, approvals and maintaining availability of products for human use. 6. Understand the scientific contents related to the development of products for human use in compliance with regulatory and legal requirements. 7. Design, apply, discuss and assess scientifically robust dossiers for medicines, food and medical devices application (MA, Experimental studies, Post-approval studies- Food safety- Pharmacovigilance and RMPs, etc) in order to market a product for human use. 8. Build up good partnerships with regulatory bodies, private companies, patient associations, patient advocate organisations, consumer organisations and other stakeholders. MASTER PROCEDURES ADMISSION REQUIREMENTS Number of candidates to be admitted is The language for instruction in the Master Programmes is English. 5

6 Language Score: YDS: 60 TOEFL: IELTS: In case no satisfactory certification of English proficiency is provided, an online proficiency test will be administered by the School of Foreign Languages at Ondokuz Mayis University (OMU). The required language proficiency test is 60. If the candidates have got a degree in English, no language test is necessary. The Master is addressed to post-graduate students in Science, Medical and Veterinary Sciences, Biology, Biotechnology, Health related degree, Law and Economics (Master s Degree corresponding to ECTS credits or an equivalent qualification to be validated by the Master Selection Committee). The candidates have to state, in submitting the application, their knowledge of English, certifying it. The candidates could enclose whatever they deem necessary to describe their curriculum. METHOD AND DEADLINE FOR SUBMISSION OF APPLICATIONS Applications for participation in the competition for admission, must be written on form (ANNEX 1), download on the websites and sent through (presidente@cum.uniba.it) and (omucmumasters@omu.edu.tr) by mail to Comunità delle Università Mediterranee, Via Celso Ulpiani 27, Bari (Italy) within the deadline of 30 th July The Administration assumes no responsibility for loss of communications and / or enrollment forms due to mistakes in delivery. CANDIDATES SELECTION The Selection Committee for admission to the Master is appointed by the Institutions promoting the Master. 6

7 FEE The fee is fixed at 3.500,00. Fees coming from candidates of Turkey and Syria should be paid to OMU account: T.C. Ziraat Bankası Samsun Kampüs Şubesi 1479 Şube Kodu SWİFT NO: TCZBTR2A IBAN NO: TR The other fees coming from any other country should be paid to CMU account: UBI BANCA CARIME (Sportello distaccato Filiale Bari 7) Via Melo, 151,70121 BARI (ITALY) IBAN: IT 57 K SWIFT CODE: CARMIT 31 The sum of Euro 54,00 as contribution for the selection (not refundable for any reason), is payable to CMU/OMU bank details according to the above mentioned citizenships. DIPLOMA The international master's diploma in Regulatory Sciences is awarded to students who: have successfully attended at least 80% of the whole amount of frontal teaching activities and passed all e-learning modules; have successfully achieved all module assessments; have completed the stage/work placement period; have successfully passed the final examination after thesis discussion. Examinations are made in dates, places and times determined and announced by the Faculty. 7

8 REFERENCES Gianni Benzi Pharmacological Research Foundation (FGB) Corso Alcide De Gasperi BARI, Italy Tel Ref: Mariangela Lupo Website: Community of Mediterranean Universities (CMU) Via Celso Ulpiani Bari Italy Tel Ref: Prof. Carlo Di Benedetta Website: Ondokuz Mayis University (OMU) Atakum, Samsun, 55200, Turkey Ref: Prof. Yüksel Kesim Website: 8