Meeting Farmacovigilanza martedì 28 ore 17 , Aula Clinica Medica III - Guest Speaker Dr David Goldsmith

[Leona Bassein <bassein@orsola-malpighi.med.unibo.it>]

Gentili Colleghi,

è presente in questi giorni a Bologna il Dr David Goldsmith, ex 
vicepresidente della Società Internazionale di Farmacoepidemiologia (ISPE) 
ed autorevole esperto di Farmacovigilanza.

Come potrete vedere dal Curriculum Vitae allegato sotto, il Dr Goldsmith 
vive a New York. Ha un background in Pediatria e Nefrologia. E' stato fino 
a pochi mesi fa Vice Presidente Internazionale della Safety & Surveillance 
della Azienda Farmaceutica Sanofi Synthelabo. Ha studiato a Bologna, dove 
torna tutti gli anni.

Gli abbiamo chiesto di tenere una lecture su alcuni aspetti della 
Farmacovigilanza, una delle priorità del nuovo Piano Sanitario Nazionale e 
uno degli obiettivi di sviluppo delle Aziende Sanitarie della Regione 
Emilia Romagna.

L'incontro, che si svolgerà martedì 28 alle ore 17, presso l'Aula della 
Medicina 3 (PAD 22) alle ore 17, avrà come titolo:

PERCHE' LA FARMACOVIGILANZA?

Mi auguro che l'incontro sia l'occasione per un confronto sugli aspetti 
scientifici e normativi della Farmacovigilanza tra i responsabili dei 
servizi di farmacovigilanza, epidemiologi, clinici, farmacologi, 
farmacisti, management delle Aziende Sanitarie e Aziende Farmaceutiche.

La lecture verrà tenuta in lingua italiana, che il Dr Goldsmith parla 
fluentemente.

Vi prego di dare massima diffusione della iniziativa ai colleghi interessati.



Dr Fausto Marchetta, Responsabile Farmacovigilanza Azienda Ospedaliera di 
Bologna - Policlinico S Orsola Malpighi
tel 335 521 8838

**

DAVID I. GOLDSMITH, MD
short biography

David I. Goldsmith, MD retired from his positition as Vice President, 
Safety Surveillance at Sanofi~Synthelabo, Inc., and does part-time 
consulting for Goldsmith Pharmacovigilance and Systems where he is the 
President and Senior Consultant.

Dr. Goldsmith received his M.D. degree from New York Medical College and is 
board certified in Pediatrics and Nephrology.

After fulfilling his military obligation at the National Naval Medical 
Center in Bethesda, MD, he conducted bench and clinical research at Albert 
Einstein College of Medicine where he served as an Associate Professor of 
Pediatrics.  During his tenure at Albert Einstein, he authored and 
co-authored more than 50 publications and was the Director of the 
coordinating center for the International Study of Kidney Disease in 
Children.  He served on the College's Institutional Review Board and 
chaired the section on adverse event evaluation.  He also served as the 
Chairman of the Subcommittee on Microprocessors, Computer Section, 
Committee on Scientific Services, for the college of medicine

Since joining the pharmaceutical industry in 1983, as Director of 
International Drug Surveillance for American Cyanamid, he has been an 
active participant in pharmacoepidemiology activities.  He served as a 
board member, Vice President and Vice President of Finance for ISPE 
(International Society of Pharmacoepidemiology) and he was the Scientific 
Program Chair for three of the International Conferences.  He was honored 
by the Society which presented whim with their first Distinguished Service 
Award from the Society in 1999.

Dr. Goldsmith has also played an active role in PhRMA (Pharmaceutical 
Research and Manufacture Association).  He is a past Chair of the Clinical 
Safety Surveillance Committee (CSSC), and has participated in the committee 
activities since 1987.  He served as the PhRMA representative to the 
initial MedDRA working party and he worked on the MedDRA Good term 
Selection: Points to consider. He was a participant in the US and 
International ICH E2 Expert Working Groups, and served the ICH as the 
Rapporteur for the ICHE2BM project,  He was also an active participant and 
industry chairperson for the implementation of Dr. Kessler's FDA MedWatch 
program, and served as an industry consultant to the FDA AERs project which 
developed the FDA database.  He was a participant in the AERs and Eprompt 
working groups for piloting electronic safety data submissions to the FDA.

Dr. Goldsmith has been an invited speaker for DIA meetings, with particular 
reference to the regulations concerning safety monitoring.  He has been 
invited to speak at numerous professional conferences sponsored by the for 
profit organizations offering courses on safety surveillance.  He is the 
Course Co-Director for the PERI Course on Adverse Event Monitoring.

In his spare time, Dr. Goldsmith is an avid opera goer, and has been a 
judge since 1984 for each of the annual New York Academy of Science High 
School Science Fairs.  He has judged both the Borough of Manhattan and City 
Wide Competitions.