FINAL PROGRAMME

PRE-CONFERENCE COURSE 1
Full Day
(09.00 - 17.30)

PART I
09.00-12.30

Basic concepts in pharmacovigilance

Chairs:
Hakan Ergün, Ankara University, Faculty of Medicine (Turkey)
Deirdre McCarthy, ISoP / Quintiles (Ireland)

PRE-CONFERENCE COURSE 2
Half Day Morning
(09.00 - 12.30)

Causality assessment in pharmacovigilance

Chairs:
Ian Boyd, Ian Boyd Consulting (Australia)
Juergen Beckmann, (Germany)

PRE-CONFERENCE COURSE 4
Half Day Afternoon
(13.30 - 17.30)

Good Pharmacovigilance Practice - Inspection and audits

Chairs:
Elliot Brown, ISoP/Elliot Brown Consulting Ltd (UK)
Sarah Daniels,TranScrip Partners LLP (UK)
Hilal İlbars, Ministry of Health General Directorate of Pharmaceuticals and Pharmacy (Turkey)

Plenary Lecture
09.30 - 10.15
Chairs: Semra Sardas, Marmara University-Faculty of Pharmacy (Turkey)
Alex Dodoo, President of ISoP, Centre for Tropical Clinical Pharmacology & Therapeutics, University of Ghana, Medical School (Ghana)

'Ethics in clinical research and in pharmacovigilance'
Joerg Hasford, IBE, University of Munich (Germany)

Session A : Epidemiology
Chairs: Sule Oktay, KAPPA Consultancy Training Research (Turkey)
Ugo Moretti, University of Verona (Italy)

11.15 - 11.45
CIOMS / WHO Working Group on vaccine pharmacovigilance: application of terms in signal detection
Priya Bahri, European Medicines Agency (UK)

Session B : Registers
Chairs: Ian Boyd, Ian Boyd Consulting (Australia)
Raquel Herrera, Hospital Nacional de Clinicas, School of Medicine, Cordoba National University (Argentina)

11.15 - 12.00
Conducting registers: Are they appropriate tools for Post Authorisation Studies? Requirements, experiences, problems
Nancy Dreyer, Outcome Sciences Inc. (US)

12.00 - 12.20
'How can researchers support
risk management?'
Saad Shakir, Drug Safety Research Unit (DSRU) (UK)

12.15- 12.30
An empirical study of exclusion criteria for disproportionality analysis
Johan Hopstadius, Uppsala Monitoring Centre, (Sweden) (OP04)

12.30 - 12.45
A reference standard for evaluating methods for drug safety signal detection using electronic healthcare records (HER) databases
Preciosa M Coloma,Department of Medical Informatics, Erasmus Medical Center (The Netherlands) (OP05)

12.45 - 13.00
Indicators of dependence and aberrant behaviours during post-marketing use of fentanyl buccal tablets: risk scores in support of
risk management
Saad Shakir, Drug Safety Research Unit, Southampton, UK; School of Pharmacy and Biomedical Sciences, University of Portsmouth, (UK) (OP22)

12.20 - 12.35
NSAID exposure and risk of acute liver failure leading to transplantation: principle results of the 7-country case-population study (SALT)
Ezgi Gülmez, Pharmacology, Université Bordeaux Segalen, INSERM U657 (France) (OP21)

12.35 - 12.50
Linking in safety with marketing support programmes
Sylvie Tomczyk, Novartis Pharma AG (UK) (OP28)

12.50-13.05
Characterization of reporting of drug induced hepatic failure to the WHO-UMC database. Influence of gender and age
Marija Petronijevic, Medicines and Medical Devices Agency of Serbia (Republic of Serbia ) (OP38)

Session C : Medication errors:
Definitions and preventability (Part I)
Chairs: Brian Edwards, NDA Regulatory Science Ltd (UK)
Ian Boyd, Ian Boyd Consulting (Australia)

14.00 - 14.45
"Better than cure"
Part 1. Defining preventability
of adverse drug reactions
R Ferner, West Midlands Centre for Adverse Drug reactions (UK)

Part 2. Assessing preventability
of adverse drug reactions
J Aronson, University of Oxford (UK)

Session D : Measuring effectiveness
in Pharmacovigilance
Chair: Nicholas Moore, University Victor Segalen, Bordeaux, France

14.00 - 14.20
Post authorisation safety studies
Oğuz Kayaalp, Honorary President of Turkish Pharmacovigilance Society (Turkey)

14.20 - 14.35
Measuring REMS effectiveness: time for program overhaul
Mary Mease, Quintiles (US) (OP03)

14.35 - 14.50
The outcome of PSUR assessment of biopharmaceuticals
Hans C Ebbers, Division of Pharmacoepidemiology and Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University (The Netherlands) (OP06)

14.50 - 15.05
Workshops and telephone-based interventions to improve ADR reporting: a cluster-randomized trial in Portugal
Teresa Ferreira Herdeiro, Unidade de Farmacovigilancia Norte, Faculdade de Medicina, Universidade do Porto; Centro de Investigaçao em Tecnologias da Saude, CITS (Portugal) (OP10)

15.05 - 15.20
Using resources for scientific driven pharmacovigilance: switching from many product safety documents to the product safety master file
Giovanni Furlan, PrimeVigilance (Italy) (OP27)

15.00 - 15.15
Evaluating visual strategies to differentiate look-alike medication names during the medication administration process
Sandra Gabriele, Department of Design, York University (Canada) (OP16)

15.15 - 15.30
Medication errors prevention strategies: examples of partnerships
Ghita Benabdallah, Moroccan Poison Control and Pharmacovigilance Centre (Morocco) (OP18)

Session C : Medication errors:
Definitions and preventability (Part II)

16.00 - 16.15
Preventable hospitalisations of internal medicine
Sven Schmiedl, Philipp-Klee Institute of Clinical Pharmacology, HELIOS Clinic Wuppertal, Germany; Department of Medicine, Faculty of Health, University Witten/Herdecke (Germany) (OP15)

16.15 - 16.30
A multicentre study on adverse drug reactions preventability
Raja Benkirane, Moroccan Pharmacovigilance Centre (Morocco) (OP19)

16.30 - 16.45
Dose omissions in hospitalised patients: an analysis of the relative contribution of adverse reactions
Jamie J Coleman, College of Medical and Dental Sciences, University of Birmingham; University Hospitals Birmingham NHS Foundation Trust, Edgbaston, (UK); (OP20)

16.45 - 17.00
Study on reliability of medicines-related information in Internet-based health sources
Hristina Lebanova, Department of Social Pharmacy, Faculty of Pharmacy, Medical University-Sofia (Bulgaria) (OP32)

Session E: Off-Label Use
Chairs:Luis Alesso, Hospital Nacional de Clinicas, School of Medicine, Cordoba National University (Argentina)
Ulrich Hagemann, ISoP (Germany)

16.00 - 16:30
'What is off-label use?' An overview
Ulrich Hagemann, ISoP (Germany)

16.30 - 16.45
Antidepressant drug prescribing in children and adolescents in Germany
Edeltraut Garbe, Bremen Institute for Prevention Research and Social Medicine, University of Bremen (Germany) (OP25)

16.45 - 17.00
Utilisation of fentanyl buccal tablets
in primary care in England:
Focus on 'off-label' use in support of
risk management
Saad Shakir, Drug Safety Research Unit, Southampton, UK; School of Pharmacy and Biomedical Sciences, University of Portsmouth (UK ) (OP13)

Session F : U-turns in treatment concepts?
Chairs: Hervé Le Louet, Henri Mondor Hospital, AP-HP (France)
Ugo Moretti, University of Verona (italy)

Post glitazones-U-Turns in treatment concepts?

08:30-09:15
Assessment of benefit versus harm in the ACCORD trial: Individualization of Glycemic Goals
Faramarz Ismail-Beigi, Case Western Reserve University, Cleveland (US)

Session G : Pharmacogenomics and monoclonals
Chairs: Semra Sardas, Marmara University-Faculty of Pharmacy (Turkey)
Jean-Michel Dogné, Department of Pharmacy, University of Namur (Belgium)

Pharmacogenomics in pharmacovigilance

08.30 - 08.40
Introduction
Jean-Michel Dogné, Department of Pharmacy, University of Namur (Belgium)

08.40 - 09.10
Perspectives in pharmacogenomics
Semra Sardas, Marmara University-Faculty of Pharmacy (Turkey)

10.30 -11.15 PLENARY LECTURE

Chairs: Mira Harrison-Woolrych, Intensive Medicines Monitoring Programme, NZ Pharmacovigilance Centre University of Otago Medical School (New Zealand)
Brian Edwards, NDA Regulatory Science Ltd (UK)

10.30-11.15
Long term effects of medicines commonly used by women
Valerie Beral, Cancer Epidemiology Unit (UK)

SESSION I: Pharmacovigilance of Women's medicines

Chairs: Mira Harrison-Woolrych, Intensive Medicines Monitoring Programme, NZ Pharmacovigilance Centre University of Otago Medical School (New Zealand)
Brian Edwards, NDA Regulatory Science Ltd (UK)

11.15 - 11.30
Venous thromboembolism and combined oral contraceptives: where is the signal?
Rudolf Stoller, Swissmedic - Swiss Agency of Therapeutic Products, (Switzerland) (OP30)

11.30 - 11.45
Pharmacovigilance of contraceptives why does it take so long to take action?
Kees van Grootheest, Netherlands Pharmacovigilance Centre Lareb and University of Groningen (OP37)

Session H: Paediatric Pharmacovigilance
Chairs: Raquel Herrera, Hospital Nacional de Clinicas, School of Medicine, Cordoba National University (Argentina)
Yola Moride, University of Montreal (Canada)

11.15-11.30
Adverse events of special interest and Pneumococcal vaccination
Carmela Santucci, Italian Medicines Agency, Pharmacovigilance Unit (Italy) (OP08)

11.30 - 11.45
Treatment of paediatric epilepsy in Germany: antiepileptic drug utilisation in children and adolescents from 2004-2006
Edeltraut Garbe, Bremen Institute for Prevention Research and Social Medicine (Germany) (OP33)

11.45 - 12.00
Adverse reactions after medication error occurred in children and Reported to the national pharmacovigilance Network
Carmela Santucci, Italian Medicines Agency, Pharmacovigilance Unit (Italy) (OP17)

Plenary Lecture
Chairs: Alex Dodoo, President of ISoP, Centre for Tropical Clinical Pharmacology & Therapeutics, University of Ghana, Medical School (Ghana)
Nicholas Moore, University Victor Segalen, Bordeaux, France

(13.45 - 14.30)
Bengt Erik Wiholm lecture
"Pharmacovigilance of an anti-malarial and other tales"
John McEwen, Australia

Session J : Vaccine pharmacovigilance
Chairs: Jerry Labadie, Uppsala Monitoring Centre
WHO Collaborating Centre for International Drug Monitoring (Sweden)
Rudolf Stoller, Swissmedic (Switzerland)

14.30 - 15.00
H1N1 and lessons learned: Specific safety concerns monitoring and epidemiology
Jerry Labadie, Uppsala Monitoring Centre (Sweden)

Session K : Education and training
Chairs: Marie Lindquist, Uppsala Monitoring Centre (Sweden)
Deirdre McCarthy, Quintiles (Ireland)

14.30 - 14.50
Training on risk-management
Elliot Brown (0P 01), Elliot Brown Consulting Ltd (UK)

HPV vaccinations: latest experiences

15.20 - 15.40
The Italian surveillance of HPV vaccination
St Spila Alegiani (OP07)

Session L : The human factor
Chairs :Eugène van Puijenbroek, Netherlands Pharmacovigilance Centre Lareb
Sevgi Öksüz, Farmateam Ltd. Sti (Turkey)

16.30 - 17.45
The human factor in risk assessment
of single cases, in general and in decision making
Brian Edwards, NDA Regulatory Science Ltd (UK)

Session M : Benefit and Harm
Chair: Juergen Beckmann (Germany)

16.30 - 17.45
Weighing benefit and harm, chance and risk
Ralph Edwards, Uppsala Monitoring Centre (Sweden)

Session N: Perception of Risk
Chairs: Bruce Hugman, Communications specialist and healthcare writer; Uppsala Monitoring Centre,
Elliot Brown, Elliot Brown Consulting Ltd (UK)

09.00 - 09.45
'Perception of risk and communication'
Ragnar Lofstedt, King's Centre for Risk Management, King's College London (UK)

Session O: Internet, ADR reporting, country reports
Chairs: Ahmet Akici, Marmara University School of Medicine Haydarpasa (Turkey)
Seyfullah Dagistanli, Turkish Pharmacovigilance Society (Turkey)

09.00-09.15
The use of Internet surveys to measure the effectiveness of educational materials for use as risk minimisation tools: what to consider?
Colin Richard Knight, TranScrip Partners LLP (UK) (OP02)