From Data Analysis to Better Health Care - Fortbildung

From Data Analysis to Better Health Care - Fortbildung

Symposium of the Swiss-Austrian ISOP Chapter

International Society of Pharmacovigilance

From Data Analysis to Better Health Care

Thursday, 13 March 2014


Lecture Hall ‚West‘

Program: Thursday, 13 March 2014, Zurich

13:00 Registration Desk Open

13:45 Welcome to the ISOP Chapter Meeting Zurich 2014

Stefan Russmann (University Hospital Zurich)

13:50 Introduction: From Data Analysis to Better Health Care

Jan Willem van der Velden (Mesama, Bözberg)

Session I (14:00 - 15:15)

Session Chair: Jan-Willem van der Velden (Mesama, Bözberg),

Mario Bertazzoli (Helsinn, Lugano)

14:00 Data Mining and Signal Detection

Jan Petracek (PharmInvent, Prague)

14:30 Electronic Prescription and Hospital Pharmacy Consultations –

An Integrative Concept

Jörg Brüggmann (Hospital Pharmacy, Accident Hospital Berlin)

Followed by Open Discussion

15:15 Coffee Break

Session II (15:45 - 17:15)

Session Chair:

Francesca Giuliani (University Hospital Zurich)

Eveline Jaquenoud Sirot (Psychiatric Services Aargau, mediQ, Königsfelden)

15:45 Clinical and Formal Causality Assessment of Adverse Drug Reactions

Patrik Stephan (Psychiatric Services Aargau, mediQ, Königsfelden)

16:15 Causality Assessment - A Regulatory Perspective

Martina Schäublin (Swissmedic, Berne)

16:25 Causality Assessment - An Industry Perspective

Mircea Ciuca (Vifor Pharma, Zurich)

Followed by Open Discussion

16:45 Bringing Safety Back to the Bedside –

“Interventional Hospital Pharmacoepidemiology”

Stefan Russmann (University Hospital Zurich)

17:15 Review and Open Discussion



Jörg Brüggmann (Berlin, Germany)

Jörg Brüggmann, PhD, is Head of the Department of Hospital Pharmacy at

the Unfallkrankenhaus Berlin. He is a member of the drug information project

(AMID) of the pharmacist chamber Berlin and has been appointed as a member

of the honorary pharmacy consulting board of the health senate of Berlin.

Jörg holds a title in clinical pharmacy, and since 2009 he is also member of the

scientific management and lecturer for the course in Clinical Pharmacy at the

Dresden International University.

Mircea Ciuca (Zurich, Switzerland)

Mircea Ciuca, MD, is Head of Medical & Clinical Drug Safety at Vifor Pharma

Switzerland, where he is leading a team of scientists and physicians involved in

all aspects of pharmacovigilance. Prior to joining Vifor Pharma he held various

positions at large pharmaceutical companies in The Netherlands, after he had

successfully established and led the medical-scientific department of a medium-sized

CRO in Rotterdam. Mircea is specialized in Emergency Medicine and

Obstetrics & Gynecology, has been involved in clinical practice and academic

teaching for about 12 years, and has about 9 years experience in drug safety.

Eveline Jaquenoud Sirot (Königsfelden, Switzerland)

Eveline Jaquenoud Sirot holds a PhD in life sciences. She worked for 15 years in

pharmaceutical industry mainly as Medical Director. Since 2000 she is heading

the Quality Center for Drug Safety of the Psychiatric Services Aargau (PDAG).

Her research interests focus on drug safety, drug-drug interactions, pharmacogenetics

and therapeutic drug monitoring. The drug interaction program

“mediQ” was created by her. Eveline is secretary to the Swiss-Austrian ISOP

chapter, former president of the Swiss Society for Drug Safety in Psychiatry

(SGAMSP), member of the international AMSP project management team, and

member of the international AGNP-TDM expert group.

Jan Petracek (Prague, Czech Republic)

Jan Petracek, MD, is partner and CEO at PharmInvent, contract safety and regulatory

science company. Until 2010 he was Head of Risk Management Section of

European Medicines Agency (EMA) responsible for all operations of the Agency

in relation to risk management of medicinal products. He holds a Master of Science

with Distinction in Quality and Safety in Healthcare from Imperial College

London. He has over 13 years of experience in all areas of pharmacovigilance,

participating in development of several national, European, ICH and CIOMS

guidelines. His main recent activities relate to risk management, improvement

of pharmacovigilance systems, he serves as EU-QPPV, and conducts independent



Stefan Russmann (Zurich, Switzerland)

Stefan Russmann, MD, is Head of Pharmacoepidemiology and Drug Safety at

the Department of Clinical Pharmacology, University Hospital Zurich, president

of the Swiss-Austrian ISOP Chapter, and board member of the Swiss Society for

Drug Safety in Psychiatry (SGAMSP). He is a board-certified clinical pharmacologist,

and setup a regional pharmacovigilance center and a team that conducted

phase I to III clinical trials at the Clinical Investigation Unit of the University

Hospital Berne. He specialized in pharmacoepidemiology and drug safety at the

Boston Collaborative Drug Surveillance Program (BCDSP) in Boston, MA, and

was Medical and Research Director at the Degge Group in Arlington, VA. Stefan

is Privatdozent for Clinical Pharmacology and Toxicology at the University of

Zurich, and Adjunct Associate Professor of Epidemiology at Boston University,


Martina Schäublin (Berne, Switzerland)

Martina Schäublin, MD, studied medicine in Vienna. After 25 years in pharmaceutical

industry, where she held different positions (Drug Safety Expert, Head

of Drug Safety and Clinical Research, Medical Director) at headquarter and

affiliates, she joined Swissmedic in May 2012, where she is currently Head of


Patrik Stephan (Königsfelden, Switzerland)

Patrik Stephan, MD, joined the medical staff of mediQ (Qualitätszentrum für

Medikamentensicherheit, Psychiatrische Dienste Aargau) in 2004. He is vice

president and drug monitor of the Swiss Society for Drug Safety in Psychiatry

(SGAMSP) and documented and evaluated himself hundreds of adverse drug

reactions. As an internist, he is also in charge of the somatic care of the patients

of the Psychiatrische Klinik Königsfelden.

Jan-Willem van der Velden (Bözberg, Switzerland)

Jan-Willem van der Velden, MD, is a registered specialist in pharmaceutical

medicine. He received his medical degree from the University of Leiden, the

Netherlands and he has clinical experience in psychiatry and oncology. He is

Past President of the International Society for Pharmacoepidemiology (ISPE)

and holds an academic position at the University of Brussels. Between 1986 and

2009 he has been the head of global (drug) safety and risk management in Solvay,

Yamanouchi and PharmaNet. Currently he advises on safety programs and

PV operations for many pharmaceutical companies and regulatory authorities in

a large variety of therapeutic and diagnostic indications. He combines consulting

with factual teaching.

General Information

Local Organization

PD Dr. med. Stefan Russmann

UniversityHospital Zurich

Division of Clinical Pharmacology and


Rämistrasse 100

8091 Zürich



UniversityHospital Zurich

Lecture Hall ‚West‘

(Main Entrance)

Rämistrasse 100

8091 Zürich


How to get there

By car

Only limited car parking near the Hospital.

Public Transport

Tramway no. 10 from Zurich Main Station.

Tram stop „ETH/Universitätsspital“ in front

of the main entrance.




3 Credits SGKPT.

25 Kreditpunkte für FPH Spitalpharmazie

und Klinische Pharmazie.


Please send an email with the header

“ISOP ZH registration”, your name,

affiliation and contact information to:

Registration fee is 50,- CHF. Student rate

is 25,- CHF, ISOP members are waived

from registration fee.

You will receive a confirmation mail with

payment information after you have registered.

On-site registration is possible

but subject to availability of seats, and

we therefore recommend pre-registration

via email.


Jörg Brüggmann (Berlin, Germany)

Mircea Ciuca (Zurich, Switzerland)

Eveline Jaquenoud Sirot (Königsfelden,


Jan Petracek (Prague, Czech Republic)

Stefan Russmann (Zurich, Switzerland)

Martina Schäublin (Berne, Switzerland)

Patrik Stephan (Königsfelden, Switzerland)

Jan-Willem van der Velden (Bözberg,


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