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Università Cattolica del Sacro Cuore
Facoltà di Medicina e Chirurgia - Roma
Società di Scienze Farmacologiche Applicate
Master di II livello
Sviluppo preclinico e clinico del farmaco:
aspetti tecnico-scientifici, regolatori ed etici.
Direttore: Prof. Pierluigi Navarra
Comitato scientifico: Gianni De Crescenzo, Francesco De Tomasi, Pierluigi Navarra,
Carlo Patrono, Antonio G. Spagnolo
Convenzionato con
Con il patrocinio di
Centre Recognition
Module 1. Introductory module. Principles of drug discovery. Non-clinical testing
On successful completion of this Module the student should be able to:
1. Outline the process of drug development and identity of critical factors and decision points.
2. Describe the background to the development of the regulation of medicines and the role of the
competent authorities.
3. Outline the role of patho-physiology and molecular biology-based pharmacology in drug development.
4. Describe the principal steps in discovering, modifying, assessing and patenting new chemical and
biological compounds (including advanced therapies) according to their therapeutic indication.
5. Describe the principles of translational research and its role in drug development.
6. Discuss the choice and predictive value of the non-clinical testing program as part of the overall drug
development plan for chemical and biological compounds.
7. Describe the integration of non-clinical tests into the overall drug development plan (including
scheduling of toxicology tests with respect to clinical trials).
8. Provide an overview of non-clinical study requirements prior to First-in-Man studies.
9. Discuss the molecular and cellular basis of toxic reactions.
10. Describe the influence of genetic factors in drug development and drug response
Module 2. Pharmaceutical development. Drug development
On successful completion of this Module the student should be able to:
1. Outline the process of drug development and identity of critical factors and decision points.
2. Outline the design of clinical trials, including legal, regulatory, ethical & practical aspects and Good
Clinical Practice (GCP).
3. Describe the procedures for clinical trial data collection (paper & electronic) and data management
(including validation processes) to ensure optimal quality data.
4. Identify the key strategic and operational issues in the clinical trial process, in terms of legislative
requirements and Good Clinical Practice (GCP).
5. Outline the principles and practical application of pharmacokinetics & toxicokinetics.
6. Outline the early exploratory development in man.
7 Discuss the principles of clinical pharmacology and their application to clinical development.
Module 3. Clinical Trials. Data management and Statistics
On successful completion of this Module the student should be able to:
1. Describe the various types of clinical studies and the methods used to choose the appropriate design.
2. Describe the main statistical methods used in clinical research.
3. Identify the key issues involved in the conduct of a clinical study including investigator and site
recruitment, investigative site management and conflict resolution.
4. Discuss the collection, evaluation and reporting of adverse event data in clinical trials.
5. Outline the various quality management issues in clinical trials.
6. Describe the impact of emerging results on the drug development plan.
7. Outline the key operational and strategic issues in the clinical development plan.
8. Explain the evaluation of the outcome of drug development: final therapeutic profile / usage of a
medicine.
9. Discuss the statistical issues in statistical report writing.
10. Describe the evaluation and interpretation of clinical trial results.
11. Illustrate the principles and practical application of critical appraisal.
Docenti
I. Andreini (RTC)
G. Assogna (S&PC)
S. Bianco (Servier)
S. Bonato (Bayer)
M. Bruzzone (AIFA)
C. Caldaroni (Sigma-Tau)
G. Capelli (Univ. Cassino)
A.P. Caputi (UniME)
M. Cicerone (UCSC)
S. Cinelli (RTC)
G.B. Ciottoli (Angelini)
U. Colangelo (Pfizer)
M. Corsi (Sigma-Tau)
D. Criscuolo (Genovax)
C. Dello Russo (UCSC)
G. De Crescenzo (Pfizer)
F. De Tomasi (SSFA PP)
A. Del Porto (MSD)
S. Digiambenedetto (UCSC)
E. Dolcini (AMGEN)
B. Federico (Univ. Cassino)
P. Ferrazza (L.N.AGE/Informa)
C. Fracasso (Pfizer)
L. Fuccella (SSFA PP)
D. Gagliardi (Un. Manchester)
D. Gallo (UCSC)
Module 4. Ethical and legal issues. Regulatory affairs
On successful completion of this Module the student should be able to:
1. Explain the importance of the patient in drug development.
2. Explain the role of the Drug Safety Monitoring Board (DSMB) and other relevant study
committees.
3. Describe the general principles of medicines regulation (both pre- & post-approval) at EU and
global level.
4. Discuss the impact of medicines legislative requirements on regulatory activities within a
pharmaceutical company.
5. Explain the role of national agencies and international bodies in medicines regulation.
6. Describe the national provisions for management of: (1) off-label / unlicensed use of medicines,
and (2) controlled drugs.
7. Discuss the place of the International Conference on Harmonisation (ICH) in medicines regulation
(including Common Technical Document [CTD]).
8. Explain the regulatory processes in the EU / EEA areas.
9. Describe the regulation & legal considerations of Product Information.
10. Outline the principles & practical application of medical devices regulation.
Module 5. Drug safety and Pharmacovigilance. Pharmacoepidemiology
On successful completion of this Module the student should be able to:
1. Discuss the roles of the various stakeholders (including pharmaceutical and other healthcare
professionals, investigators, regulatory authorities) in drug safety and pharmacovigilance.
2. Outline the classification of adverse events / adverse drug reactions.
3. Describe the safety reporting requirements (according to the type of adverse event / reaction) pre& post-approval.
4. Discuss the ongoing management of drug safety issues pre- & post-approval (including Risk
Management Plans [RMPs], Periodic Safety Update Reports [PSURs]); ongoing benefit / risk
assessment throughout the life-cycle of a medicine.
5. Discuss the role of pharmacoepidemiology in the life-cycle management of a medicine.
6. Describe the factors influencing medication safety from the perspective of each stakeholder.
Module 6. Pharmacoeconomics. Healthcare marketplace
On successful completion of this Module the student should be able to:
1. Illustrate the life-cycle management (clinical, regulatory and marketing) of medicines.
2. Describe the processes of production and review of product information to ensure adherence to
ethical and legal principles pertaining to marketing activities (Good Promotional Practice).
3. Discuss the principles & practical application of health economics and patient-reported outcomes
within the pharmaceutical industry.
4. Outline the principles of health technology assessment (HTA) and its role in the supply of
medicines to the marketplace.
5. Discuss the principles and practice of marketing within the pharmaceutical industry.
6. Discuss drug budget control; pricing mechanisms.
L. Godi (Harrison)
E. Graziano (Pfizer)
M. Kuan (LAV)
G. La Torre (UniRoma 1)
M.G. Leone (MinSan)
R. Leone (UniVerona)
G.B. Leproux (BMS)
M. Maggini (ISS)
M. Marozza (Pfizer)
M. Minà (Pfizer)
S. Montilla (AIFA)
P. Navarra (UCSC)
C. Patrono (UCSC)
R. Pelaia (Farmindustria)
A. Piccolboni (Zambon)
A. Proietti (AIFA)
E. Riva (HSR-MI)
P. Russo (AIFA)
V. Ruggeri (Servier)
A.G. Spagnolo (UCSC)
C. Savani (BMS)
R. Spezia (Sintesi)
G. Toffano (UniBO/UniPD)
C. Tomino (AIFA)
G.Traversa (ISS)
G. Tringali (UCSC)
S. Trombino (UniCAL)
C. Turriziani (Consultant QA)
M. Turrini (Bird&Bird)
S. Venturella (RTC)
Informazioni generali
Sede del Corso: Istituto di Farmacologia, Facoltà di Medicina e Chirurgia, Università Cattolica del S. Cuore, Largo F. Vito 1 - 00168 Roma
Numero di posti: minimo 10 – massimo 30.
Destinatari: laureati in Medicina e Chirurgia, Farmacia, Chimica, Chimica e Tecnologia Farmaceutiche, Veterinaria, Biologia, Biotecnologie
Mediche.
Didattica: 6 moduli didattici - 12 incontri di 25 ore ciascuno fra venerdì e sabato mattina. Sono previsti stage formativi presso Aziende
Farmaceutiche. Il calendario verrà pubblicato separatamente.
Termine delle iscrizioni: 8 Novembre 2012
Per ulteriori informazioni: Ufficio POST-LAUREA: www.rm.unicatt.it/master; telefono 0630154255
Francesco De Tomasi: [email protected] ;
Lucia Lisi: [email protected] ; telefono 06 30154367 / 4531