INTERNATIONAL MASTER
IN
PHARMACEUTICAL MEDICINE
Excellence in education for the medicine of the future
Learn more...
UniMI
Novartis
INTERNATIONAL MASTER
IN
PHARMACEUTICAL MEDICINE
Excellence in education for the medicine of the future
Learn more...
UniMI
Novartis

THE COURSE

Interaction between academia, the pharmaceutical industry and regulatory authorities is of paramount importance for ensuring the quality, efficacy and safety of drugs in clinical use.

Although collaboration between biopharma and academia is increasing, life science trainees in academia often do not get significant exposure to how biopharma industries approach drug discovery and development, and how clinical research should be performed (Lauren C. Wu, Trends in Immunology - May 2015, 36:290-292).

The foundation for a successful career in clinical pharmacology and biopharma research encompasses strong scientific training and broad technical skills. While a rigorous, critical, and thorough approach to science is always important, it nonetheless should be emphasized that a strong scientific background enables one to think broadly and creatively about scientific problems, which is essential to the successful development of new therapeutics. Since the activities of members of a clinical pharmacology project team are interconnected, it is important to be able to understand not only one's own area of clinical research but also those of the other members.

As such, multi-disciplinary training is required to provide the ability to think about all aspects of a drug discovery program and clinical development of drugs. An understanding of the clinical development process for new therapeutics is necessary to conduct the most robust and effective drug discovery research possible, and to maximize understanding of clinical data and the chances of clinical development success.

This will help to prepare postgraduate trainees for a career in clinical pharmacology research both in academia and the biopharma industry, with the objective of balancing public needs with commercial aims, and ensuring effective drug evaluation by regulatory authorities.


The course is promoted by the University of Milan, a public teaching and research university, which - with 8 faculties, 2 schools, and a teaching staff of more than 2000 professors - is distinguished by its wide variety of disciplinary fields.

A leading institute in Italy and Europe for scientific productivity, the University of Milan is the largest university in the region, with approximately 64,000 students; it is also an important resource for the socio-economic context it is a part of.

For further information, please visit http://www.unimi.it

UniMI


OBJECTIVES

OBJECTIVES

To equip participants for careers developing and expanding current knowledge of drugs and their uses in clinics, the course will provide a multi-disciplinary approach to clinical trials, data management and regulatory affairs.

The main objectives of the course are to:

  • Understand modern pharmacological principles and their clinical application
  • Apply an integrative and multidisciplinary approach to clinical research investigation
  • Design clinical research protocols
  • Interact with regulatory bodies and understand the rules for applying for research projects
  • Plan research, collect and manage clinical data
  • Apply the correct procedures for coordinating and monitoring a clinical study
  • Understand the principles of pharmacovigilance and apply the correct procedures for the surveillance of the safety of medicinal products
  • Understand the processes of production of investigational medicinal products (IMP)
  • Critically appraise research methods and experimental results
  • Communicate research results and clinical implications to a wide scientific and lay audience
  • To integrate the skills acquired, training and practical experience in the pharmacological workplace, in both academic and industry environments, are essential.

    Our Mission

    MISSION

    The course is based on close interaction between the academic study and practical experience in clinical research.

    Participants will acquire core skills, giving them an understanding of how to apply clinical pharmacological, regulatory and ethical principles to the optimization of therapeutic practice and clinical research.



    CAREER

    CAREER

    LEARNING OUTCOMES

    The course focuses on the application of pharmacological principles in clinical research, closing the gap between laboratory science and clinical practice.

    Successful participants will be able to:

  • Develop knowledge and an understanding of the principles of pharmacology in the context of modern approaches to drug development and the therapeutic action of drugs
  • Apply an integrated and multidisciplinary approach to clinical pharmacology research
  • Acquire core skills and the knowledge required to conduct, manage, and regulate clinical trials
  • Develop a clear understanding of roles and responsibilities within clinical research enterprise
  • Learning Outcomes
    Audience

    INTENDED AUDIENCE

    The Master's degree program in Pharmaceutical Medicine prepares individuals to perform valid, credible patient-based research in academia, industry, research institutes, and health and regulatory agencies.

    Linking the academic and professional scientific communities, the program is most beneficial for:

  • LM-41 MEDICINE AND SURGERY
  • LM-06 BIOLOGY
  • LM-13 PHARMACY AND INDUSTRIAL PHARMACY
  • LM/SNT1 NURSING AND MIDWIFERY SCIENCES
  • LM-9 MEDICAL, VETERINARY, AND PHARMACEUTICAL BIOTECHNOLOGIES
  • CAREER OPPORTUNITIES

    Careers in pharmaceutical medicine are very varied and can be challenging, exciting, fulfilling and rewarding. Pharmaceutical medicine offers a challenging multidisciplinary environment and one of great complexity.

    The proposed Master's degree program in Pharmaceutical Medicine may offer several career opportunities, including positions in:

  • The pharmaceutical industry
  • Clinical Research Organizations (CROs)
  • Research institutions
  • Healthcare institutions and authorities
  • Career


    PROGRAM

    PROGRAM

    DURATION

    The course comprises six modules spread over a period of one year.


    SCHEDULE

    The program is based on the general concept of "on-the-job training", meaning that there will be mainly practical activities related to all aspects of clinical research trials, helping the candidates to gain the skills needed in this field.

    Thus, the bulk of the training involves practical work with different teams involved in a multi-disciplinary approach to clinical research. The research activity takes place daily under the guidance of a tutor who will supervise the participants during their training. In fact, participants are assigned to a research group in which they will collaborate, with the objective of learning about the group's working approach and methodology.

    Participants are also expected to attend lessons, seminars, courses and congresses organized by the partner institutions. These are all important educational opportunities and attendance is compulsory for all participants.

    The course is divided into six macro-modules:

  • Theory, research practice and innovation in pharmacology
  • Ethical and legal requirements for clinical research programs
  • Clinical studies in practice: project management and coordination
  • Statistical methods in pharmacological research
  • Scientific communication
  • The drug discovery and development process, regulatory and commercial aspects of management in the pharmaceutical industry
  • The main topics covered by the specific macro-modules will be:

    Module 1

    Macro-module 1: Theory, research practice and innovation in pharmacology

    1.1 Introduction to Clinical Research

    Aim: To provide an in-depth and comprehensive understanding of the principles and practice of clinical research.

    This module provides a thorough understanding of the history and evolution of clinical research, including the principles and organization of global clinical research, the future direction of health economics, innovation in Research and Development (R&D) as a response to existing and emerging medical needs, and examples of landmark studies and controversies. The participants will examine the context in which research is undertaken (from molecular screening to Proof of Concept (PoC) and from PoC to Full Development) and consider types of studies, objectives and outcomes, definitions and phases of protocols, and the roles and responsibilities of the clinical research team and study sponsors.

    Macro-module 2: Ethical and legal requirements for clinical research programs

    2.1 Ethical, Legal, Regulatory and Financial Considerations in Clinical Investigations

    Aim: To provide an in-depth understanding of the ethical, legal, regulatory and financial dimensions of clinical research.

    This module offers an in-depth examination of ethical, legal and regulatory requirements and their interplay in clinical research. Topics include the recruitment and protection of subjects, diversity and vulnerability of populations, informed consent, privacy/confidentiality, and the role of Institutional Review Boards (IRBs) and Independent Ethics Committees (IECs). Participants will also explore international research, relationships with the industry, conflicts of interest, intellectual property rights, and publications and authorship. Budgets: how to estimate study costs; how to keep budgets under control. Grants: how to write a grant application.

    Module 2
    Module 3

    Macro-module 3: Clinical studies in practices: project management and coordination

    3.1 Designing a Clinical Protocol and Conducting a Clinical Trial

    Aim: To provide a systematic understanding and critical awareness of clinical trial protocol requirements.

    This module will cover all aspects of research design, including methods, objectives and hypothesis, specification of the study population, outcome measures, reliability and validity, randomization, documentation requirements, outsourcing and multi-centre trials. According to their postgraduate status, trainees will also actively participate in carrying out specific ongoing clinical trials at the Clinical Research Centre of the Mario Negri Institute in Ranica (Bergamo).Specific issues regarding the design and conduct of studies with "cells and gene" therapies will also be discussed extensively, including new ethical challenges (e.g. the lack of preclinical data; long-term safety in patients, "donor and patient journeys", etc).


    3.2 Good Clinical Practice (GCP) in Managing and Monitoring Clinical Trials

    Aim: To critically examine requirements of good clinical practice and to understand correct strategies and plans for developing risk-based monitoring for investigational studies.

    Participants will acquire a firm grounding in the tenets, history and regulatory context that inform GCP as defined by the International Conference on Harmonization (ICH), from study initiation to final reports. Topics include Standard Operating Procedures (SOPs), recruitment, quality assurance, data safety monitoring boards (DSMBs), multi-centre/large-scale trials, protocol management and amendments, audits, and reporting. Particular attention will be paid to monitoring, which is a necessary aspect of the processes and procedures for ensuring clinical trial quality and subject safety.


    3.3 Information and Data Management

    Aim: To provide a critical understanding of the issues surrounding efficiency and security in the context of data management in clinical research.

    In this module participants will examine the importance of information systems and information technology in increasing efficiency in the management of clinical research data. Participants will consider the application of legal and ethical principles to the development of a data collection and management plan. The module also addresses issues of confidentiality, security of information systems and electronic remote data capture (e-RDC). The value of in-stream data review and of "data analytics" models to detect safety signals or suboptimal data quality will also be addressed.


    3.4 Pharmacovigilance and Investigational Medicinal Product (IMP) Management

    Aim: To provide an understanding of the relevance and importance of the proper monitoring of study drug safety.

    This module will cover all aspects of pharmacovigilance in clinical research. Participants will consider the phases of identification, recording, reporting and analysis of safety information to ensure that any safety signals that arise during a trial are quickly identified and acted upon. Moreover, they will consider the steps of production, distribution and disposal of the investigational medicinal product according to international good manufacturing practices.

    Macro-module 4: Statistical methods in pharmacological research

    4.1 Biostatistics

    Aim: To provide an understanding of the relevance and importance of statistics in clinical research.

    This module addresses the role of biostatistics in clinical research, including descriptive methodologies, statistical tests, and confidence intervals. Participants will examine basic concepts of data collection and analysis. The module also covers the development of the Statistical Analysis Plan (SAP), preparation of the statistical report, and integration in the Clinical Study Report (CSR).

    Module 4
    Module 5

    Macro-module 5: Scientific communication

    5.1 Writing Reports and Scientific Manuscripts

    Aim: To provide an understanding of how to read the results of clinical research and how to write a scientific paper.

    Through a guided process of critical analysis, handling everyday practical problems and real research experience scenarios, participants will address and complete all phases of drafting a research paper for publication. The participant will acquire the skills necessary to succeed in publishing scientific papers in top international journals and gain an in-depth understanding of scientific peer-review publishing and how to best present their work.


    5.2 Patient Advocacy and Relations

    Aim: To understand the role of the patient in clinical research from the passive patient (the patient is a data point) to the active patient (the patient is a researcher)

    This module will explore the activities of patients' associations to support the problems faced daily by patients with chronic diseases and by their relatives, and the role of the associations in representing and informing patients. Participants will also examine increasing collaboration between patients, patient advocacy groups and academia and the pharmaceutical industry in facilitating clinical trial design and patient recruitment, as well as in funding new therapies, and how these relationships are having an impact on drug development and approval.

    Macro-module 6: The drug discovery and development process, regulatory and commercial aspects of management in the pharmaceutical industry

    6.1 Drug Registration and Approval Process

    Aim: To understand the general principles of medicine regulation (both pre- and post-approval).

    This module will provide an overview of mechanisms and regulatory processes for medicine registration across Europe, the US and Asia. In addition, it will explore documentations and collaborations between developers and regulators.


    6.2 Integrated Product Development, Healthcare Marketplace and Marketing

    Aim: To understand the principles and the practice of the quality system of drug lifecycle activities.

    This module will focus on principles of project and portfolio management and decision-making in clinical research. Ethical and legal principles of introducing a drug to the market; Good Promotional Practices. Overview of health economics and health technology assessment (HTA). Management of cross-functional teams, team-work and performance assessment.


    6.3 Roles and Responsibilities in Enterprise

    Aim: To acquire an understanding of how enterprises are organized, who the main internal stakeholders are, how to manage a matrix organization, principles of leading oneself and leading a team.

    This module will offer an overview of organizational structures, the main roles and responsibilities, principles of matrix management and influencing, principles of leadership development in the two aspects of leading oneself and leading a team (direct report team or project management/functional team), and principles of time management, facilitation skills, negotiation skills, and how to build a highly performing team.

    Module 6


    TEACHERS
    COORDINATOR Coordinator

    Giuseppe Remuzzi

    Professor of Nephrology, University of Milan - Italy
    Research Coordinator of IRCCS Mario Negri Institute for Pharmacological Research, Bergamo and Ranica - Italy

    Giuseppe Remuzzi is professor of Nephrology at the L. Sacco Department of Biomedical and Clinical Sciences, University of Milan. He is Director of the Department of Medicine of the ASST - Papa Giovanni XXIII Hospital and Head of the Division of Nephrology and Dialysis of the same hospital. Since 1984, he has been the Research Coordinator of the Anna Maria Astori Center in Bergamo and of the Aldo e Cele Daccò Clinical Research Center for Rare Diseases in Ranica (BG).

    He has made significant contributions to understanding the mechanisms of renal diseases and disease progression and to defining novel therapeutic interventions. He has extensive experience of promoting, designing and coordinating small- and large-scale randomized clinical trials and translating results into clinical practice.

    Professor Remuzzi has authored and co-authored more than 1300 scientific articles, reviews and monographs. From June 2013 until March 2015 he was President of the International Society of Nephrology (ISN).


    ACADEMIC STAFF

    Giuseppe Remuzzi
    Salvatore Siena
    Piergiorgio Messa
    Maurizio Gallieni
    "L. Sacco" Department of Biomedical and Clinical Sciences - University of Milan - Italy

    Carlo Patrono
    Università Cattolica del Sacro Cuore di Roma - Italy

    Teun van Gelder
    Department of Hospital Pharmacy and Internal Medicine, Erasmus Medical Center - The Netherlands

    Hanna I. Roos
    Department of Medicine - University of Cambridge - UK

    David J. Barlow
    Institute of Pharmaceuthical Science - King's College London - UK

    Timothy O'Brien
    Regenerative Medicine Institute, National University of Ireland, Galway, Ireland

    Norberto Perico
    Erica Daina
    Arrigo Schieppati
    Piero Ruggenenti
    Annalisa Perna
    IRCCS - Mario Negri Institute - ClinicalResearch Centre for Rare Diseases "Aldo e Cele Daccò", Bergamo - Italy

    Herbert Altmann
    Head Market Acces, Pricing and Reimbursement, Novartis Pharmaceuticals - Basel - Switzerland

    Patrizia Ciavatta
    Head Regulatory Affairs, Novartis Farma - Italy

    Guido Guidi
    Pharma Region Europe, Novartis Pharmaceuticals - Basel - Switzerland

    Alexander Meier
    Head Legal Global & Pharma Drug Development - Novartis Pharmaceuticals - Basel - Switzerland

    Giancarlo Monza
    GCO Region Europe, Novartis Pharmaceuticals - Basel - Switzerland

    Dan Bar Zohar
    Chief Scientific Officer, Novartis Farma - Italy

    STEERING COMMITTEE

    S. Siena, M, Gallieni, P. Messa, N. Perico, E. Daina, P. Castellani, G. Guidi



    TRAINING

    NOVARTIS CAMPUS

    Each student will undertake a major individual research project over the remainder of the course in one of the primary research areas in academia or the industry. The research will be supervised by senior staff.

    Based on the research project assigned to each student, an internship lasting approximately 3 months will be done at one of the Novartis sites in Europe.




    REGISTRATION

    GENERAL INFORMATION

    Publication of the notice
    December 13th, 2016 (see UniMI website)

    Deadline for application
    February 1st, 2017

    Number of participants
    The Master's degree course will be activated for a maximum of 12 students and a minimum of 9 students.

    Start date
    March 31st, 2017

    End date
    March 31st, 2018

    Credits
    60 CFU

    The registration fee is 4500€.

    The first three candidates on the ranking list will receive a scholarship equal to the tuition fee.

    Students will have the opportunity to stay at the guesthouse of the Clinical Research Centre (Ranica, Bergamo) where the main activities of the master's will take place.


    SELECTION

    Each candidate must pass a written examination (multiple choice test), which counts for 60%, as well as an interview, which counts for 20%, at the Aldo e Cele Daccò Clinical Research Centre for Rare Diseases - IRCCS - Mario Negri Institute for Pharmacological Research in Ranica (Bergamo) Italy. The number of places is limited in order to guarantee that instructors will be able to provide adequate support to participants, and to ensure the proper use of scientific equipment.

    The Curriculum Vitae et Studiorum will be assessed and will account for 20% of the evaluation (10% for publications and for the scientific value of the degree thesis, 10% for professional experience in scientific research). Applicants whose first language is not English are usually required to provide evidence of proficiency.


    For information related to administrative procedures regarding selection, registration, payment and certification of students, please refer to the Office of Doctoral and Master university:
    Tel. 02 50312302
    Fax 02 50312300
    Email master@unimi.it.



    LOCATION

    VILLA CAMOZZI

    The Aldo e Cele Daccò Clinical Research Center for Rare Diseases is located in Ranica (Bergamo) in Villa Camozzi, and has been working on promoting awareness of and treating rare diseases since 1992. The villa is dedicated to Mr and Mrs Daccò in recognition of their generous donation, which allowed the Mario Negri Institute for Pharmacological Research to completely restore Villa Camozzi.

    The Daccò Center is a unique example of an institution capable of establishing all the necessary steps in a clinical research project. To this end, scientists and professionals, such as physicians, biologists, bioengineers, nurses, biostatisticians and computer technicians, work together closely to evaluate the health status of patients, to monitor and collect data derived from clinical studies, and to process and analyze this information to ultimately determine the efficacy of possible new therapeutic strategies.


    BERGAMO

    Bergamo in the web:

  • On Wikipedia
  • Council Pages (in Italian)
  • Wikitravel Page
  • Bergamo at Mapquest
  • Villa Camozzi

    TRAVEL INFORMATIONS

    Venue
    Aldo e Cele Daccò Clinical Research Center for Rare Diseases"
    Mario Negri Institute for Pharmacological Research
    Villa Camozzi, via G.B. Camozzi, 3 - 24020 Ranica, Bergamo (Italy)
    Phone +39 035 42131

    The Aldo e Cele Daccò Clinical Research Center for Rare Diseases is located in Villa Camozzi in Ranica, 5 km from Bergamo.

    By Plane
    From Orio al Serio Airport (10 km from Bergamo), there is a bus service to Bergamo city center.
    From Milano Linate Airport (50 km from Bergamo) and Milano Malpensa Airport (120 km from Bergamo) it is possible to use public transportation to the Central Station and Milano Cadorna station.

  • Orio al Serio Airport
  • Milano Airports

  • By Train
    Bergamo is one hour from Milan (Centrale or Lambrate railway stations).
    Check the timetable on the Italian railways website at: http://www.trenitalia.it


    By Car
    The A4 highway (Milano-Venezia) connects Bergamo directly to the major Italian highway network.
    Take the Bergamo exit, at the roundabout take the second exit, in the direction of Alzano Lombardo.
    Exit at Ranica and proceed to the center.
    Follow the directions for Villa Camozzi.

  • Directions on Google Maps

  • By Bus
    Take the local ATB Bus, line 5A (from the centre of Bergamo, Porta Nuova) to Ranica. Villa Camozzi is 300 meters from the bus stop.
    Moreover, near the railway station, the Tram delle Valli (TEB) leaves every 15 minutes and stops in Ranica. The stop is a 15-minute walk from Villa Camozzi.

  • ATB Linea 5 Timetable
  • TEB Timetable


  • CONTACTS

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