Preliminary Programme

 
 
Day 1
October 2nd
Day 2
October 3rd
Day 3
October 4th
 

 

Pre Conference Courses - Tuesday, October 1st
8.00-9.00Pre conference Courses Registration
  Auditorium - Pre-conference course A   Pacinotti Hall - Pre-conference Course B
  RISK MANAGEMENT PLANNING AND ACTIVITIES: PAES AND PASS   ADVERSE DRUG REACTIONS: CLINICAL APPROACH AND DIFFERENTIAL DIAGNOSIS AS THE BASIS OF CASE QUALITY
9.00- 9.45

The need for and role of safety studies for approved medicinal products

Saad Shakir (United Kingdom)

9.00-9.45

Signals: from detection to validation

Eugène van Puijenbroek (The Netherlands)

09.45-10.30

What are PASS studies?

Yola Moride (Canada)

9.45-10.30

Case report and case causality assessment

Ronald H.B. Meyboom (The Netherlands)

10.30-11.00 Coffee break
11.00-12.00

Strengths and limitations of observational studies for RMPs (PASS, PAES and risk benefit) - theory

Stephen Evans (United Kingdom)

11.00-12.00

Signal detection from a clinical pharmacological perspective

Ronald H.B. Meyboom (The Netherlands)

12.00-13.00

Strengths and limitations of observational studies for RMPs (PASS, PAES and risk benefit) - practice

Stephen Evans (United Kingdom)

12.00-13.00

Patients/consumers report: improving the quality

Eugène van Puijenbroek (The Netherlands)

13.00-14.00 Lunch
14.00-14.30

Sources of data for PASS studies in the EU

Andrew Bate (United Kingdom)

 

 

14.30-15.15

 

 

 

 

Reporting and analyzing adverse reactions in oncology

Marco Tuccori (Italy)

14.30-15.15

De novo PASS studies: strength and challenges with primary data collection studies

Saad Shakir (United Kingdom)

15.15-16.00

The ENCEPP and its role in PASS

Nicholas Moore (France)

15.15-16.30

 

 

Reporting and analyzing  medication errors. Methodological Consideration

 Ian C. K. Wong (Hong Kong)

16.00-16.30


Observational studies and PASS - an industry perspective

Andrew Bate (United Kingdom)

16.30-17.00 Coffee break
17.00-17.30

Observational studies and PASS - a regulatory/academic perspective

Nicholas Moore (France)

17.00-17.30

 

Reporting and analyzing therapeutic failures

Marco Tuccori (Italy)

17.30-18.00

What elements of PASS are most specific to EU and which are internationally applicable?

Yola Moride (Canada)

17.30-18.00

Reporting and analyzing drug-drug interactions

Saad Shakir (United Kingdom)

18.00-18.15 Closing remarks 18.00-18.15 Closing remarks
19.00-20.00

Welcome Ceremony

Chiostro della Chiesa di S. Caterina

 

Day 1 - Wednesday, October 2nd
8.00-8.30

Registration

(registration to the conference will be available from Tuesday October 1st at 16.00-18.00)

8.30-9.30

Opening Lecture (plenary)
Chair Francesco Rossi (Italy)
Speaker Joan-Ramon Laporte (Spain)
Title The impact of adverse drug reactions on public health
  Auditorium
Parallel Session 1
  Pacinotti Hall
Parallel Session 2
9.30-11.00
Safety of antidiabetes drugs
Chairs Francesco Trotta (Italy)
Stefano Del Prato (Italy)
9.30-11.00
Pharmacovigilance in emerging countries: Counterfeit medicines and beyond
Chairs Alex Dodoo (Ghana)
Ian C. K. Wong (Hong Kong)
9.30-10.00
Speaker Riccardo Perfetti (France)
Post-marketing evaluation of antidiabetic drugs as approaches of continuous scientific accreditation
9.30-10.00
Speaker Alex Dodoo (Ghana)
Pharmacovigilance in emerging countries
10.00-10.30
Speaker Kristina Johnsson (United Kingdom)
Safety of new DPP4 inhibitors in type-2 diabetes mellitus
10.00-10.10
Speaker W.C. Tan (Singapore)
Characterization of adverse reaction reports associated with adulterated health products: Analysis of the Singapore pharmacovigilance database from 1993 to 2012
10.10-10.20
Speaker D. A. Peritwari (Indonesia)
Early drug induced liver injury after intensive phase of TB treatment in Indonesia: primary care centers and lung hospital study
10.20-10.30
Speaker C. N. Ndosiamo (Democratic Republic of Congo)
Adverse effects of oxytocin and misoprostol reported to the National Pharmacovigilance Centre after induction of labor in term parturients
10.30-10.40
Speaker J.L. Faillie (France)
Pancreatitis and use of GLP1 analogs and DPP4 inhibitors: a case/non case study from the French Pharmacovigilance database
10.30-10.40
Speaker A.A. Oumar (Mali)
Antiretroviral induced adverse drug reactions in HIV infected patients in Mali: a resource-limited setting
10.40-10.50
Speaker J. Seong (South Korea)
Dipeptidyl peptidase-4 inhibitor use and risk of acute pancreatitis in patients with type 2 diabetes
10.40-10.50
Speaker H.S. Rehan (India)
Open label, randomized controlled trial to study the effect of Atorvastatin on peripheral nervous system
10.50-11.00
Speaker Francesco Trotta (Italy)
Generic substitution of antidiabetic drugs in the elderly: does it affect adherence?
   
11.00-11.30 Coffee break and poster viewing
11.30-12.15
Bengt Erik Wiholm Lecture (plenary)
Chair Brian Edwards (United Kingdom)
Speaker Helmut Oberender (Germany)
Title Patient support programs and the new EU PV legislation
12.30-14.00 Lunch
  Auditorium
Parallel Session 3
  Pacinotti Hall
Parallel Session 4
14.00-15.30
Drug-induced gastrointestinal and liver injuries
Chairs Carmelo Scarpignato (Italy)
Sif Ormarsdottir (Iceland)
14.00-15.30
Pharmacovigilance in children
Chairs Marco Scatigna (Italy)
Annalisa Capuano (Italy)
14.00-14.30
Speaker Carmelo Scarpignato (Italy)
Safety issues with antinfalmmatory drugs in the gastrointestinal tract: from mesalazine to NSAIDs
14.00-14.30
Speaker Ian Chi Kei Wong (Hong Kong)
Medication-related problem in children
14.30-15.00
Speaker Sif Ormarsdottir (Iceland)
Drug-induced liver injury in the 21st century
14.30-15.00
Speaker Carlo Giaquinto (Italy)
Global Research in Paediatrics (GRiP) – A network of excellence improving medicine use
15.00-15.10
Speaker J. Wong (UK)
Prescribing trends of piroxicam in general practice: how has regulatory action impacted the prescribing demographics of piroxicam?
15.00-15.10
Speaker C. Ferrajolo (Italy)
Suspected adverse drug reactions in children: a descriptive study of the Italian spontaneous reporting system
15.10-15.20
Speaker S.E. Gulmez (France)
Causality of drugs involved in acute liver failure leading to transplantation: results from SALT study (Study of Acute Liver Transplant)
15.10-15.20
Speaker D. Costas (Greece)
Adverse drug reactions during antibiotics administration in hospitalized children and doctors’ attitudes and beliefs in ADRs reporting
15.20-15.30
Speaker Y. He (Hong Kong)
High-versus-low-dose histamine-2 antagonists for the prophylaxis of non-steroidal anti-inflammatory drug-associated gastrointestinal ulcers
15.20-15.30
Speaker C. Chui (Hong Kong)
Attention-deficit/ hyperactivity disorder drug prescribing trend is increasing among children and adolescents in Hong Kong: 2001-2012
15.30-16.15
Council for International Organizations of Medical Sciences (CIOMS) lecture (plenary)
Chair Gunilla Sjolin-Forsberg (Sweden)
Speaker Stephen Evans (United Kingdom)
Title Consideration for applying good meta-analysis practice to clinical safety issues
16.15-16.45 Coffee break and poster viewing
  Auditorium
Parallel Session 5
  Pacinotti Hall
Parallel Session 6
16.45-17.45
Junior Pharmacovigilance Scientists 1
Chairs Marco Tuccori (Italy)
Yola Moride (Canada)
16.45-17.45
Junior Pharmacovigilance Scientists 2
Chairs Alfredo Vannacci (Italy)
Ian Boyd (Australia)
16.45-16.55
Speaker S. Dufay (Hong Kong)
Comparison of biosimilar guidelines: impact on patient safety
16.45-16.55
Speaker Y. Ingrasciotta (Italy)
Use of nephrotoxic drugs in patients with chronic kidney disease: a population-based study in Southern Italy
16.55-17.05
Speaker J. Sultana (Italy)
Antidepressant use in Italian elderly patients: a nationwide population based-study
16.55-17.05
Speaker G. Karimi (Sweden)
Exploring the reporting of lack of effect – An inventory in VigiBase
17.05-17.15
Speaker Haleh Bagheri (France)
Does substitution of brand name medications by generics differ between pharmacotherapeutic classes? A population-based cohort study in France
17.05-17.15
Speaker H. Lebanova (Bulgaria)
"Mystery consumer" approach as evaluation of risk communication skills of community pharmacists
17.15-17.25
Speaker N. Alhazmi (UK)
Improving the PhV knowledge for medical staff of SFH during Hajj time in Makkah City, KSA toward reporting of ADRs
17.15-17.25
Speaker V. Osborne (UK)
The implications of 'off-label' use in primary care in England: An example from a post-marketing cohort study
17.25-17.35
Speaker L. Aliaga (Perù)
Pharmacovigilance of anti CD 20 monoclonal antibody biosimilar at the Edgardo Rebagliati Martins Hospital-Peru
17.25-17.35
Speaker P. Quillet (France)
Tyrosine kinase inhibitors - associated ischemic events in patients treated for chronic myeloid leukemia

 

Day 2 - Thursday, October 3rd
  Auditorium
Parallel Session 7 (symposium)
  Pacinotti Hall
Parallel Session 8
9.30-10.30
Pharmacovigilance of biotechnologics and activation immunotherapies
Chairs Piero Canonico (Italy)
Mario Del Tacca (Italy)
9.30-10.30
Pharmacovigilance of psychotropic drugs
Chairs Edoardo Spina (Italy)
Giovanni Umberto Corsini (Italy)
9.00-09.30
Speaker Michele Maio (Italy)
Safety of immunotherpies
9.00-09.30
Speaker Edoardo Spina (Italy)
Assessing the comparative safety and tolerability of  antipsychotic drugs
9.30-10.00
Speaker Romano Danesi (Italy)
Safety of target therapies: biologic vs non biologic drugs
9.30-10.00
Speaker David S. Baldwin (United Kingdom)
Assessing the comparative safety and tolerability of  antidepressant drugs
10.00-10.10
Speaker D. Mendes (Portugal)
Risk of infections and tuberculosis associated with adalimumab, etanercept and infliximab: analysis of spontaneously reported adverse drug reactions in Portugal
10.00-10.10
Speaker S. Billioti De Gage (Canada)
Benzodiazepine use and risk of dementia: a case control study using the Quebec claims database
10.10-10.20
Speaker P.R.G. Dos Santos (Brazil)
Pharmacovigilance of biotechnological therapies: How the Brazilian public pharmaceutical industry have been preparing itself?
10.10-10.20
Speaker E. van Puijenbroek (The Netherlands)
Results of the experience with the use of varenicline in daily practice using intensive monitoring
10.20-10.30
Speaker N. Vermeer (The Netherlands)
Development of safety concerns within RMPs after approval: a cohort study of biological
10.20-10.30
Speaker D. Layton (UK)
The Observational Safety Evaluation of Asenapine (OBSERVA) study: rationale and design
10.30-11.00 Coffee break and poster viewing
  Auditorium
Parallel Session 9 (symposium)
  Pacinotti Hall
Parallel Session 10
11.00-12.30
Pharmacovigilance of biosimilars
Chairs Nicholas Moore (France)
Laura Sottosanti (Italy)
11.00-12.30
Miscellanea (French language session)
Chairs Hervé Le Louet (France)
Yola Moride (Canada)
11.00-11.30
Speaker Paolo Pronzato (Italy)
Safety and efficacy of Mab in cancer in the biosimilar era
11.00-11.30
Speaker Rachida Soulaymani (Morocco)
Future challenges in Pharmacovigilance
11.30-12.00
Speaker Brigitte Keller Stanislavski (Germany)
PAES and PASS for approved biosimilar Mab
11.30-12.00
Speaker Houda Sefiani (Morocco)
Pharmacovigilance and rational use in chronical diseases
12.00-12.30
Speaker Huub Schellekens (The Netherlands)
The quality and safety of biosimilars, an update
12.00-12.10
Speaker C. N. Ndosimao (Democratic republic of Congo)
Contribution of patient reporting by phone call to spontaneous reporting and signal detection: case of antimalarial drugs
12.10-12.20
Speaker L. Ait Moussa (Morocco)
The impact of therapeutic drug monitoring in optimizing the treatment of tuberculosis.
12.20-12.30
Speaker J. Bezin (France)
Assessment of serious adverse events in academic clinical trials: concordance between investigator and sponsor
12.30-14.00 Lunch
14.00-14.45
Auditorium -Roundtable (plenary session)
Speaker Almath Spooner (Ireland)
Title PRAC (Pharmacovigilance Risk Assessment Committee): The first year of activity
Panelists Hervé Le Louet (France), Stephen Evans (United Kingdom), Jean Michel Dogné (Belgium)
14.45-15.15
Plenary session
Title ISoP General Assembly
15.15-15.45 Coffee break and poster viewing
  Plenary Session (symposium)
15.45-17.45
Signal Detection Analysis
Chairs Andrew Bate (United Kingdom)
Gianluca Trifirò (Italy)
15.45-16.15
Speaker Niklas Noren (Sweden)
New frontiers in Pharmacovigilance – highlights from the PROTECT project (Pharmacoepidemiological research on outcomes of therapeutics by European ConsorTium)
16.15-16.45
Speaker Gianluca Trifirò (Italy)
Is there any additional value in mining electronic medical records for drug safety signal detection? The EU-ADR experience
16.45-17.15
Speaker Jeff Brown (USA)
Medical product safety surveillance in the FDA Mini-Sentinel Program
17.15-17.45
Speaker Patrick Ryan (USA)
A systematic approach to risk identification and analysis: Lessons from the Observational Medical Outcomes Partnership
20.00-23.00

Social Dinner

Villa Scorzi

 

Day 3 - Friday, October 4th
  Auditorium
Parallel Session 11
  Pacinotti Hall
Parallel Session 12
8.30-10.00
Surveillance on vaccines
Chairs Francesca Menniti Ippolito (Italy)
Carmela Santuccio (Italy)
8.30-10.00
Pharmacovigilance and woman's health
Chairs Mary Mease (USA)
Maria Cristina Breschi (Italy)
8.30-9.00
Speaker Ugo Moretti (Italy)
Signal detection analysis on vaccine databases
8.30-9.00
Speaker Katarina Ilic (Serbia)
Pharmacovigilance and effectiveness of emergency contraception
9.00-9.30
Speaker Miriam Sturkenboom (The Netherlands)
Global Research in Paediatrics (GRiP) – Focus on Vaccines
9.00-9.30
Speaker Emily Banks (Australia)
Contraception and cancer
9.30-9.40
Speaker G. Roberto (Italy)
Disease-related adverse events following non-live vaccines: Analysis of the WHO Global ICSRs database, VigiBase
9.30-9.40
Speaker J.L. Montastruc (France)
Pregnancy outcome in women exposed to dopamine agonists during pregnancy: a study in EFEMERIS database
9.40-9.50
Speaker G. Sabblah (Ghana)
Adverse events following mass MenAfriVacTM Vaccination in Ghana, 2012
9.40-9.50
Speaker A. Carvajal (Spain)
Adverse events associated with emergency contraceptive: comparing the results of a follow up study with those coming from spontaneous reporting
9.50-10.00
Speaker V. Bauchau (Belgium)
Modelling relative rates of hospitalisation for febrile convulsions and severe varicella under combined MMRV compared to separate MMR+V vaccination
9.50-10.00
Speaker A. Weill (France)
Combined oral contraceptives and risk of pulmonary embolism, stroke and myocardial infarction: a cohort study of 4 million French women
10.00-10.30 Coffee break
10.30-11.15
Keynote Lecture (plenary)
Chair Ulrich Hagemann (Germany)
Speaker Priya Bahri (United Kingdom)
Title The relationship between Pharmacovigilance and the various media types: Increasing mutual understanding
  Auditorium
Parallel Session 13
  Pacinotti Hall
Parallel Session 14
11.15-12.45
Pharmacovigilance around the skin
Chairs Eugène van Puijenbroek (The Netherlands)
Giampaolo Velo (Italy)
11.15-12.45
Adverse drug reactions in the cardiovascular system
Chairs Alessandro Mugelli (Italy)
Luis Alesso (Argentina)
11.15-11.45
Speaker Jan Schroeder (Italy)
Severe cutaneous adverse drug reactions
11.15-11.35
Speaker Job Harenberg (Germany)
How to identify and to prevent safety issues of newer antiplatelet and antithrombotic treatments
11.45-11.55
Speaker T. Trenque (France)
Photosensitivity and antipsychotic
11.35-11.55
Speaker Saad Shakir (United Kingdom)
Studying the safety of new oral anticoagulants: compared to what?
11.55-12.05
Speaker S. Lee (South Korea)
Direct cost of severe cutaneous adverse reaction in a tertiary hospital in Korea
11.55-12.15
Speaker Miriam Sturkenboom (The Netherlands)
The ARITMO project: an update
12.05-12.15
Speaker G. Manso (Spain)
Spontaneous reporting of toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme associated with antineoplastic and immunomodulating agents
12.15-12.25
Speaker E. Poluzzi (Italy)
Use of antihistamines and risk of ventricular arrhythmia: a nested case-control multi-database study in 5 European countries
12.15-12.25
Speaker A. D'Alessio (Italy)
Biologic drugs and psoriasic desease: the influence of adverse drugs reactions (ADRs) on patients compliance and therapeutic failure
12.25-12.35
Speaker L. Gatta (Italy)
How safe is prucalopride for the treatment of chronic constipation? A systematic review and meta-analysis
12.25-12.35
Speaker E. Tenti (Italy)
Suspension of anti EGFR therapy for skin toxicity and reporting of suspected adverse reactions
12.35-12.45
Speaker A. Coquerel (France)
Prescriber’s knowledge about the new oral anticoagulants when the marketing authorization for atrial fibrillation occurred in France
12.45-13.30

Closing Ceremony

Hervé Le Louet (France), Corrado Blandizzi (Italy), Marco Tuccori (Italy)

Poster Prize Ceremony

ISoP 2014 Annual Meeting Presentation

Concluding remarks

Lunch