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Pre Conference Course 1 Medication errors and human factors.* ARRANGED BY ANGELA CARO AND BRIAN EDWARDS *
08:00 - 08:30
10:30 - 11:00
08:30 - 09:30
09:30 - 10:30
Registration.
Coffee Break.
Brian Edwards
Thamer Al-Shammary
SIG Group presentation:Set the scene - medication errors terms and definitions, epidemiology.
Risk factors for medication errors: what works?Current medication errors strategies (ISMP, WHO, ASHP).
11:00 - 12:00 Good case management with advice about better coding and classification.Katarina Kralova / Neslihan Mendi
12:00 - 13:0013:00 - 13:45
13:45 - 14:15Carlos Aceves González / Yordan Rodríguez
Ghita Benabdallah / Houda Sefiani
Lunch Break.Practical implications of Human Factors (The place of Ergonomic Checkpoints).
Medication error management from detection to risk minimization actions.
14:15 - 15:15 Sentinel events and analysis based on intrinsic human factors and Metacognition (Workshop).Angela Caro / Ghita Benabdallah
15:15 - 15:45 Coffee Break.15:45 - 16:15 Interactive case study: Injecting oral medicine intravenously. (Workshop)
Brian Edwards / Angela Caro and All16:15 - 16:45 Hospital experience.
Helaine Capucho16:45 - 17:15 Wrap-up and Conclusions.
Brian Edwards
Welcome Cocktail. 18:00 - 20:30
Room Huila
PRE-CONFERENCEPROGRAMME
Saturday October 26th
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PRE-CONFERENCEPROGRAMMESaturday October 26th
08:00 - 08:30
10:45 - 11:15
08:30 - 09:30
09:30 - 10:00
Registration.
Coffee Break.
Ulrich Hagemann / Pedro Lima
Deirdre McCarthy / Katarina Illic
Active pharmacovigilance fundamental aspects:• Definitions. • Regulatory aspects: FDA,EMA and Latam.
Industry perspective Global and local.
10:00 - 10:45 Methods in active pharmacovigilance:• Description • ExamplesNatalia Kocankova / Ulrich Hagemann
11:15 - 12:15
12:15 - 13:15Wendy Camelo
Methods in Pharmacoepidemiology. What do we do with PV Databases regulatory agencies?Do we have a room for improving?
Lunch Break.13:15 - 13:45 Interactive case.
Pedro Lima
15:15 - 15:45 Coffee Break.
13:45 - 15:15
16:45 - 17:15
Practical workshop. The workshop should allow participants to use the different methods in orderto become familiar with them.
Wrap-up and Conclusions. (LATAM Conclusions, perspectives and new tools).
Wendy Camelo and All
Deirdre McCarthy / Natalia Kocankova
15:45 - 16:15 Hospital Active Pharmacovigilance.Liliana Vargas
16:15 - 16:45 A successful case study of active surveillance.Carlos Maldonado
Room Cauca
Welcome Cocktail. 18:00 - 20:30
Pre Conference Course 2Active surveillance in pharmacovigilance including
pharmacoepidemiology tools.* ARRANGED BY NATALIA KOVANTOVA, PRIME VIGILANCE *
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PRE-CONFERENCEPROGRAMME
Saturday October 26th
08:00 - 08:30
10:30 - 11:00
08:30 - 09:30
09:30 - 10:30
Registration.
Coffee Break.
Gloria Giraldo / Mariano Madurga Sanz
Gloria Giraldo
Global regulations on PV for biological and biotechnological (FDA, Health Canada, EMA, ICH, WHO). Strategies and actions taken as a result of the regulations. Audit findings and improvement opportunities. Industry problems to apply regulations.
* RMP and biological and biotechnological Controversies: utility in practice, in the clinic, in theregulatory agencies. * The impact of different reference models, FDA vs EMA and WHO. * Examples.
12:30 - 13:30
11:00 - 12:00
12:00 - 12:30Stephan Jarpa / Gillian Winstanley
Lunch Break.
Practical aspects of Case Management Plan focusing on naming and traceability.
Discussion panel.
13:30 - 14:30
14:30 - 15:15
15:15 - 16:00
Interchangeability and the role of pharmacovigilance. Switch studies.
Interactive case.
Workshop feedback.
Marco Tuccori
Marco Tuccori / Santiago Schiaffino / Mariano Madurga Sanz / Gloria Giraldo
All16:00 - 16:30 Coffee Break.16:30 - 17:15
17:15 - 17:40
Patient role and impact public health.
Conclusions and wrap-up.Stephan Jarpa
Gloria Giraldo / Mariano Madurga Sanz
Room Tolima
Welcome Cocktail. 18:00 - 20:30
Pre Conference Course 3 Biological and biotechnological product safety.* ARRANGED BY GLORIA GIRALDO *
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07:30 - 08:30
09:30 - 10:30
11:00 - 11:45
11:45 - 12:30
10:30 - 11:00
12:30 - 14:00
08:30 - 09:30
Registration.
Patients in Pharmacovigilance.
Importance of Human factors in pharmacovigilance.
ENCEPP talk: assessing the impact of pharmacovigilance and interventions to minimise risk.
Coffe Break/Poster Viewing
Lunch for Delegates*Reserved area SIG Meetings*
OPENING SESSION.Sten Olsson (President of ISoP)Brian Edwards (UK) Chair ISoP 2019Angela Caro (Colombia) Co Chair ISoP 2019 Carlos Maldonado (Colombia) Claudia Vaca (Colombia)Marie Lindquist (UMC)Shanti Pal (WHO)
Helen Haskell / Evangelina Vásquez
Carlos Aceves González / Yordan Rodríguez
Agnes Kant
Room El Dorado
Sunday October 27thCONFERENCE PROGRAMME
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14:00 - 14:30 14:00 - 14:20
14:30 - 14:50 14:20 - 14:40
14:50 - 15:10
15:10 - 15:30
Parallel session ARoom El Dorado 1 Room El Dorado 2
Current approaches to Traditional ChineseMedicines (China).
Theater in indigenous populations andPharmacovigilance. (Teleconference)
Cannabis products: pharmacological andpharmacovigilance challenges.
Vigilance of cannabis products in Canada.
Abstract oral presentation:#52 - Current status and thoughts about heart injury
related to Traditional Chinese Medicine.
Abstracts oral presentation: #87 - Systematic Instructions for Haematological
Monitoring in Summary of Product Characteristics– what constitutes good practice.
#19 - MedSafetyWeek:joining forces on social media to raise
ADR awareness.
Herbal and traditional medicines SIG.
Safety issue communication requirements.
Open Discussion.
Importance of Communication inPharmacovigilance.
Parallel session B
15:30 - 16:00 Coffe Break/Poster Viewing
Coordinator: Jo Barnes
Katarina Illic
Stephanie Jack
Dr. Jia-bo Wang
L.Zhang, Y.Wen, J.Huang
Coordinator: Ulrich Hagemann
Juan Miguel Palacios
Gillian Winstanley
C.Anton, J.Coleman, R.Ferner, T.New, S.Pontefract
F.Santoro, G.Norgela
14:40 - 14:55
14:55 - 15:10
15:10 - 15:30
Sunday October 27thCONFERENCE PROGRAMME
17
Sunday October 27thCONFERENCE PROGRAMME
Room El Dorado 1 Room El Dorado 2
16:00 - 16:30 16:00 - 16:30
17:05 - 17:20 17:05 - 17:20
Moving vaccine pharmacovigilance into the 21st century.
Abstract oral presentation:#91 - Vaccines safety in children and in general
population: a pharmacovigilance study onadverse events following immunization in Italy.
Transcelerate projects in PV.
Abstract oral presentation:#143 - Creation of an Innovation Function in
Pharmacovigilance.
What’s new from North America and EU? Safe use of Vaccines.Chair: Gloria Giraldo
Jose Vega
Jose Vega / Fabio Lievano / Felix Arellano
S.Beauchamp, N.Tetarenko, S.Desai, R.Mockute,D.Abatemarco, B.Assuncao, M.Widdowson, E.Mingle
Rebecca Chandler
Alex Dodoo
F.Lippi, G.Crescioli, M. Del Lungo, M.Rossi, C.Azzari,R.Bonaiuti, M.Levi, P.Bonanni, N.Lombardi, S.Ricci,
A.Bettiol, L.Giovannetti, C.Ravaldi, M.Parrilli, V.Borsi
Chair: Houda Langar
16:30 - 17:05 16:30 - 17:05Panel Discussion. Progress with malaria vaccine.
Parallel session C Parallel session D
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08:30 - 09:00 08:30 - 09:00
09:00 - 10:00 09:00 - 10:00
Parallel session E
Abstract oral presentation:
Risk management and Signal detection.
PV Education experience of LATAM. Symposium.Digital approaches to risk minimisation.
Biotechnological and biosimilars drugs.
Challenges in Latin-American Pharmacovigilance.
Parallel session F
10:00 -10:30 Coffe Break/Poster Viewing
Chair: Jean-Christophe Delumeau Chairs: Luis Alesso / Raquel Herrera
Jorge Machado / Adalton Ribeiro /Raquel Herrera / Luis Alesso
Dirige: Marco Tuccori / Fabio Lievano /Gillian Winstanley / Pedro Lima
Mark Perrott
H.Sefiani, I.Talibi, G.Benabdallah, L.Alj , A.Tebaa,R.Soulaymani Bencheikh
M.Forstner
P.Ryan, R.Chandler
#14 - Application of Qualitative method to detect signals and manage alerts in pharmacovigilance: Moroccan
experience.
#29 - Digital tools for the communication of riskminimization measures for medicines.
#5 - Integrated use of spontaneous reports of adversedrug reactions and observational healthcare data in
signal assessment.
Discussion.
Room El Dorado 1 Room El Dorado 2Monday October 28th
CONFERENCE PROGRAMME
19
Monday October 28thCONFERENCE PROGRAMME
11:45 - 12:30
Parallel session G
Expert Panel discussion on women’s medicines.
Abstract oral presentation:#147 - How the Romanian women perceive the
advantages and risks of the contraceptives?
Parallel session H
10:30 - 10:35
10:35 - 11:10
11:10 - 11:30
11:30 - 11:45
10:30 - 11:30 Welcome and introduction.
International overview of long-acting reversiblecontraceptives (LARCs) for women.
Teleconference.
Mifespristone introduction experience.
Medicines for Reproductive Health:International and local perspectives for
Latin American Women.
Panel.
Desafios de la farmacovigilancia “Spanishcommunity” España, Latam y USA.
Chair: Dr. Mira Harrison-Woolrych
Dr. Mira Harrison-Woolrych
Prof. Sam Rowlands
Ulrich Hagemann / Raquel Herrera / Katarina Illic /PROFAMILIA representantes
PROFAMILIA: Juan Carlos Vargas /Fidel Ramírez / Andres Reyes
A.Butuca, L.Rust, C.Morgovan, I.Lupse, A.Juncan,L.Vonica Tincu, F.Gligor, A.Muntean, S.Ghibu
Chair: Angela Caro / Mariano Marduga
OD.Arias Romero
S.Schiaffino, L.Rodrigues, R.Moraes, P.Santos,C.Travassos
Evangelina Vasquez (Patient vision), Pilar Lagos (Regulatory)Elki Sollenbring (UMC)
Stephan Jarpa (Public Health and Pharma Industry)Wendy Camelo (Pharmacoepidemiology)
Claudia Vaca (WHO)Liliana Vargas Neri (Hospital Vision)
Open panel with public.
Abstracts oral presentation.
11:30 - 12:00
12:00 - 12:30
#37 - Impact and Characterization of the DrugRelated Problems Reported by Polymedicated Inpatients
with Prolonged Stays.
#46 - Initiative to increase PV awareness and supportaccess to medication for the patient.
Room El Dorado 1 Room El Dorado 2* Conference language: Spanish
20
12:30 - 13:30 Lunch for Delegates*Reserved area Chapter Meetings*
13:30 - 14:45 ISoP GENERAL ASSEMBLY
1. Welcome and approval of Agenda and Minutes General Assembly Geneva.
3. Financial position and membership fee for 2020.
5. ISoP Advisory Board Elections 2019.
2. Fellowship awards.
4. Highlights since Geneva (governance, partnership, meetings, chapters and SIGs).
6. Planning for the future.
7. Any other business.
Room El Dorado 2
Monday October 28thCONFERENCE PROGRAMME
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Monday October 28thCONFERENCE PROGRAMME
15:30 - 16:00 15:30 - 16:00Abstracts oral presentation: Abstracts oral presentation:
14:45 - 15:30 14:45 - 15:30
Parallel session I
Brazil:
Mexico:
Latin America perspective:
Asia:
Industry Contribution to the developmentof effective global and national
pharmacovigilance systems.
Impact in real life: are we making a difference? (Hospital/community vision)
Parallel session J
Chair: Katarina Illic
Helaine Capucho
Liliana Vargas Neri
T.M. Alshammari, N.Alghaythi, A.Alshammari,A.Altebainawi
C.A.Calderon Ospina, M.Galvez Bermudez, C.Lopez Cabra, F.Aristizabal Gutierrez, P.Laissue Hormaza, D.Fonseca
Mendoza, J.Rodriguez
Gillian Winstanley
Jean-Christophe Delemeau
K.Pisani, V.Hernandez
Chair: Marco Tuccori
#59 - Patient counselling practice among healthcareprofessionals in Saudi Arabia: its impact on patient safety.
#129 - Differences in Pharmacovigilance RegulatoryRequirements in Latin America countries (LATAM).
#110 - Medication errors and genetic factors aspossible causes of therapeutic failures and
adverse drug reactions in a group of Colombian epilepsy patients.
16:00 - 16:20 Coffe Break/Poster Viewing
Room El Dorado 1 Room El Dorado 2
22
Monday October 28thCONFERENCE PROGRAMME
16: 20 - 17:00
16: 20 - 17:00
Chapters Session
Africa Chapter.
North American Chapter
Middle East:
Latest news about ISoP Chapters.Chair: Brian Edwards
Sten Olsson
Veronique Kugener
Thamer AlShammaryItaly Chapter:Marco Tuccori
South East Europe:
Pacific Rim Chapter:
Indonesia:
Katarina Illic
Mira Harrison-Woolrych
Jean-Christophe Delumeau
17:00 - 17:40
Special Interest Group Session
SIGs Risk Communication, Medication Errors, Women’s Medicines Group Risk Minimisation Methods for Asian countries, Herbal and Traditional Medicines, PV Professional Qualification Framework, Medical Devices.
What SIGs exist, why and how can I join a SIG?Chair: Deirdre McCarthy
19:00 - 19:30 Transportation to the Gala Dinner venue.
20:00 - 24:00 Gala Dinner.
17:45 - 18:10 “Going Further Together” . A film about global medicines safety from Uppsala Monitoring Centre.
Room El Dorado
Room El Dorado
23
09:00 - 09:30
10:00 - 10:40
11:00 - 11:45
14:00
10:40 - 11:00
12:30 - 14:00
09:30 - 10:00
Strengthening the capacity for signal detection and management for national centres.(Uppsala Monitoring Centre).
Smart Safety Surveillance: what, why and how.
End of the meeting.
Coffee Break
Lunch
Bengt Erik Wiholm Lecture.Which are the new opportunities for new generations?
11:45 - 12:30 Posters and abstracts awards.Host presentation for ISoP 2020 in Oman
Mariano Madurga Sanz
Dr. Birgitta Grundmark
Shanti Pal
Dr. Mayada Alkhakany
Tuesday October 29thCONFERENCE PROGRAMME
Room El Dorado
CIOMS Lecture.CIOMS Update about hepatoxicity and DILI.Chair: Hervé Le Louët / Dr. Olry AlexandreSpeaker: Einar S. Björnsson
