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Tuesday September 20th

Pre-Conference Courses


08:00 - 17:00
PRE-CONFERENCE COURSE 1:
Advanced signal detection


Chair: TBD
Chair: TBD

Signal detection is one of the main activities of Pharmacovigilance. The approach to signal generation, refinement, and confirmation has evolved over years, opening to new frontiers of debate about the roles of different stakeholders in the process and the need for an implementation of regulatory framework, publication rules, and risk communication strategies. In 2021, the circumstances of the approval of COVID-19 vaccines were exceptional and provided an unprecedent challenged for signal detection that deserve to be studied in depth. This one-day pre-conference course will illustrate the process of signal detection with a step by step approach, starting from basic elements and arriving to the discussion over the most modern challenges.

08:00 - 12:30
PRE-CONFERENCE COURSE 2:
Introduction to pharmacoepi studies and their role in Pharmacovigilance


Chair: Rebecca Chandler (ISoP Vice-President, Coalition for Epidemic Preparedness Innovations)
Chair: TBD
14:00 - 17:00
PRE-CONFERENCE COURSE 3:
Regulatory Updates across the Continuum of Spontaneous Reporting to Risk Minimization


Chairs: Deirdre McCarthy (ISoP EC member, AlloVir) and Giampiero Mazzaglia (Milano Bicocca university)

Coordinated by Deirdre McCarthy (EC member, ISoP 2022 SC) and Giampiero Mazzaglia (University of Milano-Bicocca), this half-day course will address regulatory challenges and ‘state-of-the-art’ methodological approaches to current issues across the continuum of spontaneous reporting to risk minimization.
With a multi-region focus, learn about how the QPPV role has evolved to deal with increasingly complex pharmacovigilance regulations; hear from EMA speakers about the EU’s novel analytical methodologies in signal detection and risk assessment and methods for effectiveness evaluation of risk minimisation measures (RMMs); and learn about how Morocco is prioritizing multi-stakeholder involvement in risk management planning and implementation on a local level.
There will be plenty of time for Q&A and we look forward to lively discussion.

18:00
Welcome cocktail

Wednesday September 21st 

08:00 - 08:30
Registration
08:30 - 09:00
1A0 Opening session

Mira Harrison-Woolrych (President of ISoP)
Angela Caro Rojas - Scientific Chair ISoP 2022
Gianluca Trifirò - Local Chair ISoP 2022
Giorgio Racagni - President of the Italian Society of Pharmacology
Speaker: TBD

Remembering Sten Olsson - Mira Harrison-Woolrych (President of ISoP)

09:00 - 10:30
Plenary Session 1A: Lessons learned from COVID 19 pandemic

Chairs: Gianluca Trifirò (ISoP Board member, UNIVR) and Achille P. Caputi (former President of the Italian Society of Pharmacology)
09:00 - 09:30
1A1:

Speaker: TBD
How postmarketing drug/vaccine surveillance has been dealt with in Europe?
09:00 - 10:00
1A2:

Speaker: Patrizia Popoli (President of Scientific Technical Committee of the Italian Drug Agency)
COVID19 pandemic: the experience of the Italian Drug Agency
10:00 - 10:30
Panel: Q&A
10:30 - 11:00
Break
11:00 - 12:30
Parallel session 1BTraditional and innovative approaches for postmarketing surveillance of COVID 19 vaccines

Chair: Rebecca Chandler (ISoP Vice-President,
Coalition for Epidemic Preparedness Innovations)
Chair: TBD
11:00 - 11:30
1B1:

Speaker: Miriam Sturkenboom (University of Utrecht):
A large distributed European database network for rapid COVID-19 vaccine surveillance
11:30 - 12:00
1B2:

Speaker: Karina Top (Canadian Center for Vaccinology
Dalhousie University, IWK Health Centre),
Advancing the Science of Vaccine Safety: Introducing the International Network of Special Immunisation Services
12:00 - 12:30
Q&A
12:30 - 14:00
Lunch
14:00 - 15:30
Parallel session 1C:
PV of Biotechnology drugs:
from Advanced Therapy medicine products to biosimilars

Chairs: Qun Ying Yue (Chair of the Pharmacogenomics SIG, Uppsala Monitoring Centre) and Annalisa Capuano (PRAC Member - University of Naples)
14:00 - 14:30
1C1:

Speaker: Thijs Giezen (member of EMA Biosimilar working party):
Interchangeability between originators and biosimilars: Clinical and methodological considerations
14:30 - 15:00
1C2:

Speaker: Ylenia Ingrasciotta (University of Messina):
Large scale research network for biologic post marketing surveillance in Italy
15:00 - 15:10
1C3 (Abstract)
15:10 - 15:20
1C4 (Abstract)
15:20 - 15:30
Q&A
15:30 - 16:00
Break
16:00 - 17:30
Parallel session 1E:
How to communicate risk in crisis?


Chairs: Priya Bahri (Chair of the Risk Communication SIG, European Medicines Agency) and Ulrich Hagemann
16:00 - 16:10


Introduction with examples of various crisis scenarios in pharmacovigilance
Priya Bahri, Chair
16:10 - 16:30
1E1:

Speaker: Kenneth Hartigan-Go (Asian Institute of Management): How do regulatory decisions relate to public health decisions?
Communicating about Dengvaxia in the Philippines between science and emotion
16:30 - 17:00
1E2:

Speakers: TBD
How do local contexts relate to public health communication? - Communicating about COVID-19 vaccines in Italy and the Netherlands
17:00 - 17:10
1E3 (Abstract)
17:10 - 17:20
1E4 (Abstract)
17:20 - 17:30
Discussion moderated by Co-Chair Ulrich Hagemann) and Wrap-up (Chair Priya Bahri)
Social Activity (optional)
14:00 - 15:30
Parallel session 1D:
Strategies to prevent Medication errors: new approaches


Chairs: Brian Edwards (Chair of the Medication Error SIG, Husoteria Ltd) and Angela Caro (Scientific Chair ISoP 2022, ISoP Board member)
14:00 - 14:30
1D1:

ECAMET:
Speaker: TB
14:30 - 15:00
1D2:

ISMP -ISoP Projects
Speaker: TBD
15:00 - 15:10
1D3 (Abstract)
15:10 - 15:20
1D4 (Abstract)
15:20 - 15:30
Q&A
15:30 - 16:00
Break
16:00 - 17:30
Parallel session 1F:
Medicines for Women: Global Challenges and Initiatives


Chair: Mira Harrison-Woolrych (ISoP President, Chair of the Women's Medicines SIG)
16:00 - 16:10
1F1: 30 mins

Speaker: TBD
Pregnant women in clinical trials-ethical, scientific and safety aspects
16:10 - 16:30



16:30 - 17:00
1F2:

Speaker: Birgitta Grundmark (Norwegian Medicines Agency): COVID-19 vaccination and menstruation
17:00 - 17:10
1F3 (Abstract)
17:10 - 17:20
1F4 (Abstract)
17:20 - 17:30
Q&A
Social Activity (optional)

Thursday September 22nd

08:30 - 10:10
Plenary Session 2A: Big Data for PV - are we delivering on the promises?

Chair: Deirdre McCarthy (ISoP EC member, AlloVir)
Chair: TBD
08:30 - 09:00
2A1:

Speaker: Gianluca Trifirò: Big data vs. smart data for post-marketing surveillance of drugs/vaccines
09:00 - 09:30
2A2:

Speaker: TBD
How big data support postmarketing surveillance in USA: the Sentinel initiative
09:30 - 10:00
2A3:

Speaker: Andrej Segec (EMA): Data Analysis and Real World Interrogation Network (DARWIN EU®)
10:00 - 10:10
Q&A
10:10 - 10:40
Break
10:40 - 12:00
Parallel session 2B:
AI/Machine learning for drug safety signal detection in PV: where do we stand?


Chairs: Antoine Pariente (University of Bordeaux) and Rosa Gini (Agenzia regionale di sanità della Toscana)
10:40 - 11:10
2B1:

Speaker: Andrew Bate (GSK)
Current status of machine learning across the pharmacovigilance lifecycle: A systematic review
11:10 - 11:40
2B2:

Speaker: Antoine Pariente
AI/Machine learning for drug safety signal detection in PV: where do we stand? The perspective of a public pharmacovigilance center
11:40 - 11:50
2B3 (Abstract)
11:50 - 12:00
Q&A
10:40 - 12:00
Parallel session 2C:
Clinical decision supporting PV


Chairs: Mónica Tarapués (ISoP Board member, Central University of Ecuador) and Birgitta Grundmark (Norwegian Medicines Agency)
10:40 - 11:10
2C1:

Speaker: Joan Ramon Laporte (Autonomous University of Barcelona) The potential contributions of pharmacovigilance to healthy medical prescribing
11:10 - 11:40
2C2:

Speaker: Prof. Eugène Van Puijenbroek
Clinical decision supporting PV
11:40 - 11:50
2C3 (Abstract)
11:50 - 12:00
Q&A
12:00 - 13:00
Lunch
13:00 - 14:30
2E3 (ISoP General Assembly):
Committed to safer use of medicines worldwide
14:30 - 15:00
Break
15:00 - 16:30
2E4: Global Pharmacovigilance: Hot topic
Chairs: Mónica Tarapués & Angela Caro
Including flash presentations abstracts
SIGs & Chapters highlights
16:30 - 17:00
Q&A
18:30 - 00:00
Gala Dinner – Palazzo Verita

Friday September 23rd

09:00 - 10:30
Parallel Session 3A:
Training in PV, Professional framework of PV


Chairs: TBD
09:00 - 09:30
3A1:

Speakers: TBD
09:30 - 10:00
3A2:

Speaker: Francesco Salvo (University of Bordeaux): the Eu2P experience
10:00 - 10:10
3A3 (Abstract)
10:10 - 10:20
3A4 (Abstract)
10:20 - 10:30
Q&A
09:00 - 10:30
Parallel session 3B:
Herbal and Traditional Medicines PV Advances


Chairs: Souad Skalli (Chair of ISoP Herbal and Traditional Medicines SIG, Mohammed V University) and Francesca
Menniti Ippolito (Italian National Health Institute and Chair of herbal remedies monitoring in Italy)
09:00 - 09:30
3B1:

Speaker: Souad Skalli (Morocco): Restructuring of the University Curriculum by Introducing the Teaching of Phytovigilance: Importance or even Urgency
09:30 - 10:00
3B2:

Speaker: Francesca Menniti Ippolito
Introductory remarks/ Food supplements vigilance systems in a public health perspective: the European context
10:00 - 10:10
3B3 (Abstract
10:10 - 10:20
3B4 (Abstract)
10:20 - 10:30
Q&A
10:30 - 11:00
Break
11:00 - 11:50
3C1: Lecture in memory of Prof. Giampaolo Velo

Chair: Roberto Leone (UNIVR)
Speaker: Ralph Edwards (former Director of UMC): Eco to the future (10 mins only)
Speaker: TBD
11:50 - 12:20
3D1: Bengt Erik Wiholm Lecture

Saad Shakir (DSRU): 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 and new President
Angela Caro Rojas
Gianluca Trifirò
13:00 - 14:00
Lunch box
14:00 - 17:00
Optional: Social Activity