Conference Programme

This is the latest programme, which will be updated during the following weeks.

You can download the programme in PDF HERE.

Wednesday
Thursday
Friday

CONFERENCE PROGRAMME

WEDNESDAY 21 SEPTEMBER 2022

08:00

08:30

Registration

08:30

09:00

1A0:

Opening session

Mira Harrison-Woolrych (President of ISoP, New Zealand)

Angela Caro Rojas (Scientific Chair ISoP 2022, Pontificia Universidad Javeriana, Colombia)

Gianluca Trifirò (Local Chair ISoP 2022, University of Verona, Italy)

Giorgio Racagni (President of the Italian Society of Pharmacology, Italy)

Pierfrancesco Nocini (University of Verona, Italy)

Plenary Session 1A

Lessons learned from COVID 19 pandemic

Chairs: Gianluca Trifirò (ISoP Board member, University of Verona, Italy) and Achille P. Caputi (former President of the Italian Society of Pharmacology, Italy)

09:00–10:00

09:00

09:30

1A1:

How post marketing drug/vaccine surveillance has been dealt with in Europe?

Bernard Bégaud (Emeritus Professor in the Department of Health of the University of Bordeaux, France and chair of the EPIPHARE scientific committee)

09:30

10:00

1A2:

COVID 19 pandemic: the experience of the Italian Drug Agency

Patrizia Popoli (President of Scientific Technical Committee of the Italian Drug Agency, Italy)

10:00

10:30

Panel: Q&A

10:30

11:00

Coffee Break & Poster viewing

Plenary Session 1B

Traditional and innovative approaches for post marketing surveillance of COVID 19 vaccines

Chair: Rebecca Chandler (ISoP Vice-President, Coalition for Epidemic Preparedness Innovations, Sweden), Evelina Tacconelli (University of Verona, Italy)

11:00–12:30

11:00

11:30

1B1:

large distributed European database network for rapid COVID-19 vaccine surveillance

Miriam Sturkenboom (University of Utrecht, Netherlands)

11:30

12:00

1B2:

Advancing the Science of Vaccine Safety: Introducing the International Network of Special Immunisation Services

Karina Top (Canadian Center for Vaccinology Dalhousie University, IWK Health Centre, Canada)

12:00

12:30

Discussion / Q&A

12:30

14:00

Lunch Break

Parallel session 1C

14:00–15:30

Parallel session 1D

14:00–15:30

PV of Biotechnology drugs: from Advanced Therapy medicine products to biosimilars

Chairs: Qun Ying Yue (Chair of the Pharmacogenomics SIG, Uppsala Monitoring Centre, Sweden) and Annalisa Capuano (PRAC Member - University of Naples, Italy)

Strategies to prevent Medication errors: new approaches

Chairs: Brian Edwards (Chair of the Medication Error SIG, Husoteria Ltd, UK) and Angela Caro Rojas (Scientific Chair ISoP 2022, Pontificia Universidad Javeriana, Colombia)

14:00

14:30

1C1:

Interchangeability between originators and biosimilars: Clinical and methodological considerations

Thijs Giezen (member of EMA Biosimilar working party, Netherlands)

1D1:

ECAMET Alliance

TBD

14:30

15:00

1C2:

Large scale research network for biologic post marketing surveillance in Italy

Ylenia Ingrasciotta (University of Verona, Italy)

1D2:

Interaction between the Institute for Safe Medication Practices (ISMP) and ISoP

Rita Jew (Institute for Safe Medication Practices (ISMP), USA)

(Virtual presentation)

15:00

15:10

1C3

(Abstract Presentation)

Effectiveness and Tolerance of Biotherapy in the Treatment of Chronic Inflammatory Diseases and Rheumatism in children

Rania Mourchid (School of Medicine and Pharmacy, Mohammed V University, Morocco)

1D3

(Abstract Presentation)

Potentially Inappropriate Medication in Older Adult’s Adverse Drug Reactions Spontaneous Reports

Fátima Roque (Research Unit for Inland Development, Polytechnic of Guarda (UDI-IPG), Portugal)

15:10

15:20

1C4

(Abstract Presentation)

European Pharmacovigilance Analysis of Cardiac Arrhythmias Events with Immune Checkpoint Inhibitors

Annamaria Mascolo (University of Campania Luigi Vanvitelli, Italy)

1D4

(Abstract Presentation)

Analysis of Medication Errors in Children and Adolescents Reported to HALMED

Morana Pavičić (HALMED, Croatia)

15:20

15:30

Q&A

Q&A

15:30

16:00

Coffee Break & Poster viewing

Parallel session 1E

16:00–17:30

Parallel session 1F

16:00–17:30

How to communicate risk in crisis?

Chairs: Priya Bahri (Chair of the Risk Communication SIG, Netherlands) and Ulrich Hagemann (ISoP, Germany)

Medicines for Women: Global Challenges and Initiatives

Chair: Mira Harrison-Woolrych (President of ISoP, Chair of the Women’s Medicines SIG, New Zealand) and Brian Edwards (Chair of the Medication Error SIG, Husoteria Ltd, UK)

16:00

16:10

Introduction with examples of various crisis scenarios in pharmacovigilance

Priya Bahri (Chair of the Risk Communication SIG, Netherlands)

16:00

16:10

Welcome and Introduction to the session and to the ISoP Women’s Medicines SIG

Mira Harrison-Woolrych (President of ISoP, Chair of the Women’s Medicines SIG, New Zealand)

16:10

16:30

1E1:

How do regulatory decisions relate to public health decisions? Communicating about Dengvaxia in the Philippines between science and emotions

Kenneth Hartigan-Go (Asian Institute of Management, Philippines)

16:10

16:40

1F1:

Pregnant women in clinical trials: ethical, scientific and safety aspects

Katarina Ilic (Takeda, USA)

16:30

17:00

1E2:

How do local contexts relate to public health communication? – Communicating about COVID-19 vaccines in Italy and the Netherlands

Marco Tuccori (University Hospital of Pisa, Italy) andAgnes Kant (The Netherlands Pharmacovigilance Centre Lareb)

16:40

16:50

1F2

(Abstract Presentation)

Impact of the 2018 Pregnancy Prevention Program on the Use of Oral Retinoids in Childbearing Age Females in Europe

Carlos Durán (University Medical Center Utrecht, Netherlands)

17:00

17:10

1E3

(Abstract Presentation)

Animated Explainer Videos as an Effective Way to Communicate Statistical Methods in Pharmacovigilance

Eva-Lisa Meldau (Uppsala Monitoring Centre, Sweden)

16:50

17:20

1F3:

COVID-19 vaccines and menstrual disorders

Birgitta Grundmark (Norwegian Medicines Agency, Sweden)

17:10

17:20

1E4

(Abstract Presentation)

Visual Communication of Safety Data in Ongoing Studies: The Adaptive Benefit-Risk Assessment tool for Clinical Trials (ABRA-CTV)

Christopher T. Bond (Bristol Myers Squibb, USA)

17:20

17:30

1F4:

Discussion

17:20

17:30

Discussion moderated by Co-Chair Ulrich Hagemann and Wrap-up

Chair: Priya Bahri (Chair of the Risk Communication SIG, Netherlands)

18:00

19:00

ISoP Special Interest Groups (SIGs) meeting

CONFERENCE PROGRAMME

THURSDAY 22 SEPTEMBER 2022

Plenary Session 2A

Big Data for PV – are we delivering on the promises?

Chair: Gianmario Candore (Bayer, Germany) and Deirdre McCarthy (ISoP EC member, Gates MRI, USA)

08:30–10:10

08:30

09:00

2A1:

Big data vs. smart data for post-marketing surveillance of drugs/vaccines

Gianluca Trifirò (University of Verona, Italy)

09:00

09:30

2A2:

How big data support post marketing surveillance in USA: the Sentinel initiative

Darren Toh (Department of Population Medicine at Harvard Medical School and Harvard Pilgrim Health Care Institute, USA)

09:30

10:00

2A3:

Data Analysis and Real World Interrogation Network (DARWIN EU®)

Andrej Segec (European Medicines Agency – EMA, Netherlands)

10:00

10:10

Q&A

10:10

10:40

Coffee Break & Poster viewing

Parallel session 2B

10:40–12:00

Parallel session 2C

10:40–12:00

AI/Machine learning for drug safety signal detection in PV: where do we stand?

Chairs: Antoine Pariente (University of Bordeaux, France) and Rosa Gini (Agenzia regionale di sanità della Toscana, Italy)

Interaction between Pharmacovigilance and Clinical Practice

Chairs: Mónica Tarapués (ISoP Board member, Central University of Ecuador) and Birgitta Grundmark (Norwegian Medicines Agency, Sweden)

10:40

11:05

2B1:

Current status of machine learning across the pharmacovigilance lifecycle: systematic review

Andrew Bate (GSK, UK)

2C1:

The potential contributions of pharmacovigilance to healthy medical prescribing

Joan Ramon Laporte (Autonomous University of Barcelona, Spain)

11:05

11:30

2B2:

AI/Machine learning for drug safety signal detection in PV: where do we stand? The perspective of public pharmacovigilance center

Antoine Pariente (University of Bordeaux, France)

2C2:

Do we really understand what happened? – Reflections on case assessment

Eugene Van Puijenbroek (The Netherlands Pharmacovigilance Centre Lareb)

11:30

11:40

2B3

(Abstract Presentation)

Performance of an Artificial Intelligence System Tool for the Detection of ADRs from Patients’ Reports During the Covid-19 Vaccination Campaign

Guillaume Louis Martin (Synapse Medicine, France)

2C3

(Abstract Presentation)

Search for Additional Cases in Electronic Health Records (EHRs) to Strengthen Potential Signals from Spontaneous Reporting

Agnes Kant (The Netherlands Pharmacovigilance Centre Lareb)

11:40

11:50

2B4

(Abstract Presentation)

Investigating Hidden Networks in Spontaneous Reporting Systems

Michele Fusaroli (University of Bologna, Italy)

2C4

(Abstract Presentation)

Do Monitored Dosage Systems Increase Risk for Patients' Safe Discharge from Hospital? A Retrospective Analysis of Pharmacists' Interventions

Leeanne Stewart (University of Birmingham, UK)

11:50

12:00

Q&A

Q&A

12:00

13:00

Lunch Break

2D: ISoP General Assembly

Committed to safer use of medicines worldwide

13:00–14:30

14:30

15:00

Coffee Break & Poster viewing

2E: Global Pharmacovigilance: Hot topics

Chairs: Mónica Tarapués (ISoP Board member, Central University of Ecuador) & Angela Caro Rojas (Scientific Chair ISoP 2022, Pontificia Universidad Javeriana, Colombia)

15:00–17:30

15:00

15:45

2E1

SIGs & Chapters highlights

15:45

17:30

2E2

Abstract presentations

2E2.1:

Signal of Hypertension Associated with COVID-19 Vaccination: VigiBase® Data and Evidence from Real World

Marco Bonaso (University of Pisa, Italy)

2E2.2:

Risk of Glaucoma Diagnosis in Patients Who Received Intravitreal Injections of VEGF Inhibitors: a Cohort Study

Andrea Spini (Azienda Ospedaliera Universitaria Senese, Italy)

2E2.3:

A Revised Time-to-onset Signal Detection algorithm in the Context of Mass Vaccination

Lionel Van Holle (OpenSourcePV, Belgium)

2E2.4:

Adverse Events to COVID-19 Vaccines and Policy Considerations that Inform the Funding of Safety Surveillance in Low- and Middle-Income Countries

Comfort Ogar (WHO, Nigeria)

2E2.5:

Factors Associated with Hospital Death in Patients with Adverse Drug Events in Brazil, from 2011 to 2020

Paulo Sérgio Dourado Arrais (Universidade Federal do Ceará, Brazil)

2E2.6:

Effectiveness and Safety of Maintenance Immunosuppressive Drug Therapies in Kidney Transplant: A Real-World Retrospective Cohort Study in Italy

Marco Finocchietti (ASL Roma 1, Italy)

2E2.7:

Are COVID-19 Vaccines Safe in Children? Comparative Analysis of European Web-Based Prospective Monitoring vs. Pivotal Trials

Nicoletta Luxi (University of Verona, Italy)

2E2.8:

The Risk of Oligospermia with Tyrosine Kinase Inhibitors: A Disproportionality Analysis from Vigibase and AERS Databases

Luis Velez-Nandayapa (University of Basel / Novartis, Switzerland)

2E2.9:

Perception and Utilization of Skin Lightening Agents Among Females of Asmara City: A Lesson for Strengthening Cosmetovigilance

Mulugeta Russom (Ministry of Health, Eritrea)

2E2.10:

Drug-related Hospital Admissions in Paediatrics – Is There Potential for Prevention?

Irmgard Toni (Universitätsklinikum Erlangen, Germany)

19:30

22:00

Conference Dinner – Palazzo Verita Poeta

CONFERENCE PROGRAMME

FRIDAY 23 SEPTEMBER 2022

Parallel session 3A

09:00–10:30

Parallel session 3B

09:00–10:30

Training and Professional framework of PV

Chairs: Linda Harmark (The Netherlands Pharmacovigilance Centre Lareb) and Jan Petracek (ISoP Board member, Institute of Pharmacovigilance, Czech Republic)

Herbal and Traditional Medicines PV Advances

Chairs: Souad Skalli (Chair of ISoP Herbal and Traditional Medicines SIG, Mohammed University, Morocco) and Francesca Menniti Ippolito (Italian National Health Institute and Chair of herbal remedies monitoring in Italy)

09:00

09:20

3A1:

PV specialist professional development

Jan Petracek (Institute of Pharmacovigilance, Czech Republic)

09:00

09:30

3B1:

Restructuring of the University Curriculum by Introducing the Teaching of Phytovigilance: Importance or even Urgency

Souad Skalli (Chair of ISoP Herbal and Traditional Medicines SIG, Mohammed University, Morocco)

09:20

09:40

3A2:

The Eu2P experience

Speaker: Francesco Salvo (University of Bordeaux, France)

09:00

10:00

3B2:

Introductory remarks/ Food supplements vigilance systems in public health perspective: the European context

Francesca Menniti Ippolito (Italian National Health Institute and chair of Herbal Remedies Monitoring, Italy)

09:40

10:00

3A3:

Pharmacovigilance training for health care professionals

Linda Harmark (The Netherlands Pharmacovigilance Centre Lareb)

10:00

10:10

3A4

(Abstract Presentation)

Development and Evaluation of a Blended Pharmacovigilance e-Learning Course in Africa

Lara Magro (University of Verona, Italy)

10:00

10:10

3B4

(Abstract Presentation)

Recommended Best Practices of Pharmacovigilance of Herbal Medicinal Products

Florence Van Hunsel (The Netherlands Pharmacovigilance Centre Lareb, Netherlands)

10:10

10:20

3A5

(Abstract Presentation)

Teaching Pharmacovigilance to French Medical Students during the Covid-19 Pandemic: Interest of Distance Learning Clinical Reasoning Sessions

François Montastruc (Toulouse University Hospital, France)

10:10

10:20

3B5

(Abstract Presentation)

Safety of Medical Cannabis: A Descriptive Study using the Quebec Cannabis Registry

Yola Moride (YolaRX Consultants, Canada)

10:20

10:30

Q&A

10:20

10:30

Q&A

10:30

11:00

Coffee Break

11:00

11:50

3C1:

Lecture in memory of Prof. Giampaolo Velo

Chair: Roberto Leone (University of Verona, Italy)

Speaker: Ralph Edwards (former Director of Uppsala Monitoring Centre, Sweden): Eco to the future

Speaker: TBD

11:50

12:20

3D1:

Bengt Erik Wiholm Lecture

Chair: Mira Harrison-Woolrych (President of ISoP, New Zealand)

Speaker: Saad Shakir (Drug Safety Research Unit, UK): Pharmacovigilance: where we are, where we came from and where we are going

12:20

12:30

3D2:

Posters and abstracts awards

12:30

12:40

3D3:

Host presentation for ISoP 2023

12:40

13:00

3D4:

Final remarks and closure

Mira Harrison-Woolrych (President of ISoP, New Zealand)

Angela Caro Rojas (Scientific Chair ISoP 2022, Pontificia Universidad Javeriana, Colombia)

Gianluca Trifirò (Local Chair ISoP 2022, University of Verona, Italy)