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THE EUROPEAN MEDICINES REGULATORY NETWORK: PRESENT AND FUTURE

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PRESENT AND FUTURE

X Foresight Training Course

organised by

Gianni Benzi Pharmacological Research Foundation

Master in Regulatory Sciences ‘Gianni Benzi’- University of Pavia

In collaboration with

Istituti Clinici Scientifici Maugeri Società Italiana Attività Regolatorie

27th – 28th October, 2017

Aula Adolfo Bogoncelli, Istituti Clinici Scientifici Maugeri - Pavia (Italy)

Course Scientific Committee

Viviana Giannuzzi - Gianni Benzi Foundation, Maurizia Dossena - University of Pavia, Paola Baiardi - Istituti Clinici Scientifici Maugeri, Enrico Bosone - Società Italiana Attività Regolatorie

Supported by

Italian Medicines Agency

National Institute of Health

University of Pavia Associazione Italiana Contract Research

Organization

Regione Lombardia

COURSE OBJECTIVES:

- To describe the main interesting innovations in the European Pharmaceutical System - To putting the patients in the core of the system

-To address the appropriate use of experimental and real world data as sources of clinical evidence

-To revise criteria for sustainability and appropriateness of pharmaceutical care

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27 October 2017 Welcome address

Istituti Clinici Scientifici Maugeri – Paolo Migliavacca University of Pavia – Francesco Svelto

Master in Regulatory Sciences ‘Gianni Benzi’ – Maurizia Dossena Farmindustria – Giovanni Giuliani

9.00

Introduction A. Ceci – E. Bosone

The European regulatory system: plans and actions at a glance Gianni Benzi Foundation

9.30

Lecture

Data Protection and Privacy: the new European Regulation A. Spina, EMA – European Medicines Agency

10.00

First Session

Experimental and Real world data: collect, archive and share to increase their value in research

Chair: A. Ceci Sharing and re-use of individual participant data from clinical trials

J. Demotes

European Clinical Research Infrastructure Network

10.30

Share patients data for secondary use: the existing models and trends

F. Bonifazi

Gianni Benzi Foundation 11.00

Quantitative methods and evidence synthesis using healthcare data

O. Della Pasqua

University College London GlaxoSmithKline R&D

11.30

Gain evidence from innovative study designs for clinical trials

P. Baiardi

Istituti Clinici Scientifici Maugeri

12.00

How to exploit the power of data variety for research and clinical practice

L. Sacchi

University of Pavia 12.30 Discussants

A. Spina, EMA – European Medicines Agency

G. Giuliani, Farmindustria - Roche

13.00

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HTA programs at European and National level Chairs: P. Lago – J. Torrent Farnell

The Health technology assessment (HTA): a national framework to advance welfare systems

M. Marchetti

ISS – Istituto Superiore di Sanità

14.30

Health technology assessment (HTA) criteria in the light of current R&D trends

G. Giuliani

Farmindustria - Roche 15.00

Outcomes research and outcomes management in the light of health assessment

I. Springhetti

Istituti Clinici Scientifici Maugeri

15.30

Harnessing the Power of Real World Data G. Pasciullo

Bluebirdbio 16.00

Discussants

F. Panzeri, Quintiles

F. Bonifazi, Gianni Benzi Foundation

16.30

17.00 end of the day

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28 October 2017 Third Session

Innovative Medicines access in the EU Chairs: A. Spina – M. Migdal

Reconciling clinical evidence for Orphan Medicines and Access Policies

J. Torrent Farnell

Catalan Health Service 9.00

Experiences in the advocacy for Patient’ Rights D. Quaggia

Active Citizenship Network 9.20

OMP registries: are they a tool to cover the gap? V. Giannuzzi

Gianni Benzi Foundation 9.40

Timely access to therapies for severe diseases with unmet medical need

E. Bosone

SIAR - Società Italiana Attività Regolatorie

10.00

Discussants

D. Criscuolo, Genovax

R. Barbon Galluppi, Federazione Italiana Malattie Rare Onlus

10.20

Lecture

National Agencies: the role and relevance in the EU Regulatory Network M. Melazzini, AIFA – Agenzia Italiana del Farmaco

11.00

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Patients involvement and rights in the regulatory framework Chairs: T. Iorno – E. Bosone

Medicine Agencies responsibility of keeping patients informed while covering their needs

A. Cieslik

Polish Office for

Registration Director of Department of Assessment of Medicinal Products

12.00

Contribution of Expert Patients in the assessment’

process of innovative medicines

L. A. Brunetta Fondazione Italiana

“Leonardo Giambrone” per la Guarigione dalla

Talassemia

Thalassemia International Federation

12.20

Involve the younger in safe medicinal development plans

L. Ruggieri

Gianni Benzi Foundation M. Lupo

Consorzio per Valutazioni Biologiche e Farmacologiche

12.40

Protect the experimental patients population: a key role for Ethics Committees

M. Migdal

Children’s Memorial Health Institute

13.00

Discussants

D. Bonifazi, Consorzio per Valutazioni Biologiche e Farmacologiche

A. Altavilla, Aix-Marseille University

13.30

Riferimenti

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