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PARTICIPANTS<br />

Patrizia Aducci, Director of Biology Department, University of Rome Tor Vergata<br />

Enrico Bollero, General Director Polyclinic Tor Vergata<br />

Daniele Bravi, Group Director Europe & Canada, International Clinical Research, H. Lundbeck<br />

Sergio Chimenti, Full Professor of Dermatology, Faculty of Medicine, University of Rome Tor Vergata<br />

Vittorio Colizzi, Full Professor of General Patology, Faculty of Sciences, University of Rome Tor Vergata<br />

Antonio Costanzo, Assistant Professor of Dermatology, Faculty of Medicine, University of Rome Tor Vergata<br />

Gianfranco De Bernardi, Director Biopharmaceutical Sandoz, Milan<br />

Ralph Fassey, Lundbeck Director, Milan<br />

Giorgio Federici, Full Professor of Clinical Biochemistry, Faculty of Medicine,University of Rome Tor Vergata<br />

Paolo Grillo, Merk Serono, Rome<br />

Renato Lauro, Dean of the Faculty of Medicine, University of Rome Tor Vergata<br />

Paolo Luly, Full Professor of General Physiology, Faculty of Sciences, University of Rome Tor Vergata<br />

Pietro Masi, Vice-Rector University of Rome Tor Vergata<br />

Mauro Massa, Chiesi Farmaceutici, Parma<br />

Gennaro Melino, Full Professor of Molecular Biology, Faculty of Medicine, University of Rome Tor Vergata<br />

Enrico Miceli, Novartis, Rome<br />

Robert Nisticò, Associate Professor of Pharmacology, Faculty of Pharmacy, Calabria University, Cosenza<br />

Giuseppe Novelli, Full Professor of Human Genetics, Faculty of Medicine, University of Rome Tor Vergata<br />

Maurizio Paci, Full Professor of Biochemistry, Faculty of Sciences, University of Rome Tor Vergata<br />

Onofrio Palombella, GlaxoSmithKline,Verona<br />

Mauro Piacentini, Full Professor of Developmental Biology,Faculty of Sciences,University of Rome Tor Vergata<br />

Paolo Preziosi, Emeritus Professor of Pharmacology, Catholic University, Rome<br />

Salvatore Puscio, Acaya Consulting, Rome<br />

Paola Ricci, Merk Serono, Genève<br />

Francesco Romeo, Full Professor of Cardiology, Faculty of Medicine, University of Rome Tor Vergata<br />

Pasqualino Rossi, Head, European Assessment Department, AIFA, Rome<br />

Giuseppe Rotilio, Full Professor of Biochemistry, Faculty of Sciences, University of Rome Tor Vergata<br />

Leonardo Santi, President of CNBBSV, Presidency of the Council of Ministers<br />

Nicola Vittorio, Dean of the Faculty of Sciences, University of Rome Tor Vergata<br />

Post-graduate students of the master: “Scientific and Regulatory Assessment of New Medicines”<br />

Members of the Medical and Sciences Faculties, University of Rome Tor Vergata<br />

�<br />

How to integrate and standardize<br />

ASSESSMENT REPORTS<br />

OF MEDICINAL PRODUCTS<br />

in Europe<br />

�<br />

<strong>Round</strong> <strong>Table</strong><br />

28-29 March 2008<br />

Villa Mondragone<br />

Monte Porzio Catone, Rome


H ONORARY C OMMITTEE<br />

Prof. Rita Levi Montalcini, President<br />

Thomas Lönngren, Executive Director, European Medicines Agency (EMEA), London<br />

Eric Abadie, President of the CHMP, EMEA, London<br />

S ECRETERIAT<br />

Rita Baboro<br />

CNBBSV, Presidency of the Council of Ministers<br />

Tel. + 39 06 67794243 – E-mail: nistico@uniroma2.it<br />

Maria Lo Ponte<br />

University of Rome Tor Vergata<br />

Filippo Gesualdi<br />

Accademia Romana di Scienze Mediche e Biologiche<br />

Friday 28 March 2008<br />

19:00 Welcome Cocktail<br />

20:00 Social Dinner<br />

T OPICS OF THE R OUND T ABLE<br />

• The needs of a continuos education for AR<br />

• A better cooperation between MS Agencies and EMEA to improve the master<br />

• Specific professional competences available in MS<br />

• Candidates for the fellowships for next Master<br />

• Proposals by delegates of activities to complete the master course<br />

Saturday 29 March 2008<br />

10:00 Welcome and presentation of 30 fellowships<br />

for the Master – A. Finazzi Agrò and N. Vittorio<br />

Introduction – G. Nisticò and N. Martini<br />

Thomas Lönngren, EMEA road map for the new entry MS in EU<br />

Eric Abadie, European guidelines, the role of a network among all MS<br />

11:00 Coffee Break<br />

11:15 R OUND T ABLE<br />

BULGARIA – Dimiter Terziivanov, Medical University Sofia, CHMP Member<br />

CYPRUS – Arthur Isseyegh, Ministry of Health, Nicosia, CHMP Member<br />

CZECH REPUBLIC – Ondrej Slanar, Praha, CHMP Alternate Member<br />

CZECH REPUBLIC – Milan Sarek, Post-graduate student at the Master, Rome<br />

GREECE – Nikolaos Drakoulis, University of Athens, CHMP Member<br />

HUNGARY – János Borvendég, Budapest Medicines Agency, CHMP Member<br />

ITALY – Pasqualino Rossi, Rome, CHMP Alternate Member<br />

ITALY – Onofrio Palombella, Representative of Advisory Board, Industries<br />

LA<strong>TV</strong>IA – Juris Pokrotnieks, Riga, CHMP Member<br />

LITHUANIA – Romaldas Maciulaitis, State Medicines Central Agency, CHMP Member<br />

MALTA – Patricia Vella Bonanno, Malta Member of the Management Board, EMEA<br />

MALTA – Michael Chetcuti, Post-graduate student at the Master, Rome<br />

POLAND – Michal Pirozynski, President Post-graduate Medical University, Warsaw, CHMP Member<br />

SLOVAKIA – Jan Mazag, National Medicines Agency, Bratislava, CHMP Member<br />

13:30 Lunch at Villa Mondragone

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