This is the latest programme, which will be updated during the following weeks.
You can download the programme in PDF HERE.
| CONFERENCE PROGRAMME | |||||||||||
| WEDNESDAY 21 SEPTEMBER 2022 | |||||||||||
| 08:00 | 08:30 | Registration Polo Zanotto, ground floor, Main entrance | |||||||||
| 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) | Room T2/T3 | ||||||||
| Plenary Session 1A Lessons learned from COVID 19 pandemic Chairs: Gianluca Trifirò (ISoP Board member, University of Verona, Italy) and Achille P. Caputi (Emeritus Professor of the University of Messina, Italy) | 09:00–10:30 Room T2/T3 | ||||||||||
| 09:00 | 09:30 | 1A1: How post marketing drug/vaccine surveillance has been dealt with in Europe? Bernard Bégaud (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 | Q&A / Panel discussion | |||||||||
| 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 Room T2/T3 | ||||||||||
| 11:00 | 11:30 | 1B1: A 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 | Q&A / Panel discussion | |||||||||
| 12:30 | 14:00 | Lunch Break & Flash Poster Presentations | |||||||||
| Parallel session 1C | 14:00–15:30 Room T2 | Parallel session 1D | 14:00–15:30 Room T3 | ||||||||
| 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 Campania Luigi Vanvitelli, Italy) | Strategies to prevent Medication errors: new approaches Chairs: Brian Edwards (Chair of the Medication Error SIG, Husoteria Ltd, UK) and Angela Caro Rojas (Pontificia Universidad Javeriana, Colombia) | ||||||||||
| 14:00 | 14:30 | 1C1: Interchangeability between originators and biosimilars: Clinical and methodological considerations Thijs Giezen (EMA Biosimilar working party, Netherlands) | 1D1: ECAMET Alliance: Patient Safety Project experience Alix Bullman (ECAMET Alliance, Belgium) | ||||||||
| 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) | ||||||||
| 15:00 | 15:10 | 1C3 (Abstract Presentation) O-001 Effectiveness and Tolerance of Biotherapy in the Treatment of Chronic Inflammatory Diseases and Rheumatism in children Rania Mourchid (Mohammed V University, Morocco) | 1D3 (Abstract Presentation) O-003 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) O-002 European Pharmacovigilance Analysis of Cardiac Arrhythmias Events with Immune Checkpoint Inhibitors Annamaria Mascolo (University of Campania Luigi Vanvitelli, Italy) | 1D4 (Abstract Presentation) O-004 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 Room T2 | Parallel session 1F | 16:00–17:30 Room T3 | ||||||||
| 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) and Agnes Kant (The Netherlands Pharmacovigilance Centre Lareb) | 16:40 | 16:50 | 1F2 (Abstract Presentation) O-007 Impact of the 2018 Pregnancy Prevention Program on the Use of Oral Retinoids in Childbearing Age Females in Europe Judit Riera (Julius Center for Health Sciences and Primary Health, University Medical Center Utrecht (UMCU), The Netherlands) | ||||||
| 17:00 | 17:10 | 1E3 (Abstract Presentation) O-005 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, Norway) | ||||||
| 17:10 | 17:20 | 1E4 (Abstract Presentation) O-006 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 | 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 | 19:30 | Student Meet and Greet | Cloister of San Francesco | ||||||||
| 18:00 | 19:00 | ISoP Special Interest Groups (SIGs) meeting 1. Medication errors 2. Risk Communication 3. Vaccines 4. EcoPV | Room 1.4 Room S8 Room S9 Room T1 | ||||||||
| 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 (Gates MRI, USA) | 08:30–10:10 Room T2/T3 | ||||||||
| 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 (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 | |||||||
| 10:40–12:00 Room T2/T3 | Parallel session 2C | 10:40–12:00 Room T1 | |||||||
| 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 (Central University of Ecuador) and Birgitta Grundmark (Norwegian Medicines Agency, Norway) | ||||||||
| 10:40 | 11:05 | 2B1: Current status of machine learning across the pharmacovigilance lifecycle: A 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 a 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) O-008 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) O-010 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) O-009 Investigating Hidden Networks in Spontaneous Reporting Systems Michele Fusaroli (University of Bologna, Italy) | 2C4 (Abstract Presentation) O-011 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 | ||||||
| 13:00 | Lunch Break & Flash Poster Presentations | ||||||||
| 2D: ISoP General Assembly Committed to safer use of medicines worldwide Chairs: Mira Harrison-Woolrych (President of ISoP, New Zealand) and Deirdre McCarthy (Secretary General, Gates MRI, USA) | 13:00–14:30 Room T2/T3 | ||||||||
| Agenda 1. Welcome, introductions, housekeeping 2. Tribute to Sten Olsson 3. Approval of Agenda 4. Approval of Minutes GA 2021 5. President’s overview of ISoP activities 6. Report from the new ISoP Scientific Board 7. By-law updates 8. Membership Report | 9. Financial Report 10. Report from Chapters 11. Report on SIGs 12. Fellowship and Honorary Member Awards 2022 13. Advisory Board election results 14. Looking forward 15. AoB and Q&A | ||||||||
| 14:30 | 15:00 | Coffee Break & Poster viewing | |||||||
| 2E: Global Pharmacovigilance: Hot topics Chairs: Mónica Tarapués (Central University of Ecuador) and Angela Caro Rojas (Pontificia Universidad Javeriana, Colombia) | 15:00–17:30 Room T2/T3 | ||||||||
| 15:00 | 15:45 | 2E1 SIGs & Chapters highlights | |||||||
| 15:45 | 17:30 | 2E2 Abstract presentations 2E2.1 - O-012: Signal of Hypertension Associated with COVID-19 Vaccination: VigiBase® Data and Evidence from Real World Marco Bonaso (University of Pisa, Italy) 2E2.2 - O-013: 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 - O-014: A Revised Time-to-onset Signal Detection algorithm in the Context of Mass Vaccination Lionel Van Holle (OpenSourcePV, Belgium) 2E2.4 - O-015: 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) (Virtual presentation) 2E2.5 - O-016: 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 - O-017: 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 - O-018: 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 - O-019: 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 - O-020: 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 - O-021: Drug-related Hospital Admissions in Paediatrics – Is There Potential for Prevention? Irmgard Toni (Universitätsklinikum Erlangen, Germany) | |||||||
| 19:30 | 22:00 | Conference Dinner – Giardino e Palazzo dei Conti Giusti | |||||||
| CONFERENCE PROGRAMME | |||||||||
| FRIDAY 23 SEPTEMBER 2022 | |||||||||
| Parallel session 3A | 09:00–10:30 Room T1 | Parallel session 3B | 09:00–10:30 Room T2/T3 | ||||||
| Training and Professional framework of PV Chairs: Linda Härmark (The Netherlands Pharmacovigilance Centre Lareb) and Jan Petracek (Institute of Pharmacovigilance, Czech Republic) | Herbal and Traditional Medicines PV Advances Chairs: Souad Skalli (Chair of ISoP Herbal and Traditional Medicines SIG, Mohammed V 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 V University, Morocco) | ||||
| 09:20 | 09:40 | 3A2: The Eu2P experience Francesco Salvo (University of Bordeaux, France) | 09:00 | 10:00 | 3B2: Introductory remarks/ Food supplements vigilance systems in a 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 Härmark (The Netherlands Pharmacovigilance Centre Lareb) | |||||||
| 10:00 | 10:10 | 3A4 (Abstract Presentation) O-022 Development and Evaluation of a Blended Pharmacovigilance e-Learning Course in Africa Lara Magro (University of Verona, Italy) | 10:00 | 10:10 | 3B3 (Abstract Presentation) O-024 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) O-023 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 | 3B4 (Abstract Presentation) O-025 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 | |||||||
| 3C: Lecture in memory of Prof. Giampaolo Velo Chair: Roberto Leone (University of Verona, Italy) | 11:00 - 11:50 Room T2/T3 | ||||||||
| 11:00 | 11:05 | 3C1: Introduction Roberto Leone (University of Verona, Italy) | |||||||
| 11:05 | 11:20 | 3C2: Remembering Giampaolo Velo Ralph Edwards (former Director of the Uppsala Monitoring Centre, Sweden) | |||||||
| 11:20 | 11:50 | 3C3: EcoPharmacovigilance: challenges and opportunities John Wilkinson (University of York, UK) | |||||||
| 3D: Bengt Erik Wiholm Lecture Mira Harrison-Woolrych (President of ISoP, New Zealand) | 11:50 - 12:25 Room T2/T3 | ||||||||
| 11:50 | 11:55 | 3D1: Introduction Mira Harrison-Woolrych (President of ISoP, New Zealand) | |||||||
| 11:55 | 12:25 | 3D2: Pharmacovigilance: where we are, where we came from and where we are going Saad Shakir (Drug Safety Research Unit, UK) | |||||||
| 3E: Closing Ceremony Chairs: Mira Harrison-Woolrych (President of ISoP, New Zealand) | 12:25 - 13:00 Room T2/T3 | ||||||||
| 12:25 | 12:35 | 3E1: Poster Prize Awards Poster Prize Committee: Ghita Benabdallah (Chair)(Centre Anti Poison et de Pharmacovigilance du Maroc (CAPM), Morocco), Helaine Carneiro Capucho (Brazilian Health Regulatory Agency - ANVISA, Brazil), Ylenia Ingrasciotta (University of Verona, Italy) | |||||||
| 12:35 | 12:45 | 3E2: Host presentation for ISoP 2023 | |||||||
| 12:45 | 13:00 | 3E3: Final remarks and closure | |||||||
| 13:00 | 14:00 | Light Lunch | |||||||