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Saturday October 26thPre Conference Course 1
Medication errors and human factors
- Arranged by Angela Caro and Brian Edwards -
08:00 - 08:30
08:30 - 09:30
09:30 - 10:30
11:00 - 12:00
13:00 - 13:45
Registration.
SIG Group presentation: Set the scene - medication errors terms and definitions, epidemiology.
Risk factors for medication errors: what works? Current medication errorsstrategies (ISMP, WHO, ASHP).
Good case management with advice about better coding and classification.
Extrinsic Human Factors (Working environment, Fatigue, Stress, Blame culture ) Relevance for team working, culture change, leadership.
Brian Edwards (UK)
Thamer Al-Shammary / Mayada Alkhakany
Katarina Kralova / Neslihan Mendi (Support)
Carlos Aceves González / Yordan Rodríguez
10:30 - 11:00
12:00 - 13:00
Coffee Break
Lunch Break
Saturday October 26th
Medication errors and human factors- Arranged by Angela Caro and Brian Edwards -
Pre Conference Course 1
13:45 - 14:15
14:15 - 15:15
Medication error management from detection to risk minimization actions.
Sentinel events and analysis based on intrinsic human factors and Metacognition (Workshop).
Ghita Benabdallah / Houda Sefiani
Angela Caro / Ghita Benabdallah
15:45 - 16:15
16:15 - 16:45
16:45 - 17:15
Interactive case study: Injecting oral medicine intravenously. (Workshop)
Hospital experience.
Wrap-up and Conclusions.
All
Helaine Capucho
Brian Edwards (UK)
15:15 - 15:45 Coffee Break
Saturday October 26thPre Conference Course 2
08:00 - 08:30
08:30 - 09:30
09:30 - 10:00
10:00 - 10:45
11:15 - 12:15
Registration.
Active pharmacovigilance fundamental aspects:• Definitions• Regulatory aspects: FDA,EMA and Latam
Methods in active pharmacovigilance:• Description• Examples
Methods in Pharmacoepidemiology:What do regulatory agencies do with PV Databases?Do we have a room for improvement?
Industry perspective Global and local.
10:45 - 11:15
12:15 - 13:15
Coffee Break
Lunch Break
Pedro Lima / Natalia Kocankova
Deirdre MacCarthy / Katarina Ilic
Natalia Kocankova
Wendy Camelo
Active surveillance in pharmacovigilance including pharmacoepidemiology tools- Arranged by Natalia Kovantova, Prime Vigilance -
Saturday October 26thPre Conference Course 2
13:45 - 15:15
16:45 - 17:15
13:15 - 13:45
15:45 - 16:15
16:15 - 16:45
Practical workshop.The workshop should allow participants to use the different methods described to enhance their familiarity with them.
Wrap-up and Conclusions (LATAM Implications, perspectives and new tools).
Interactive case.
Hospital setting: Active Pharmacovigilance.
A successful case study of active surveillance.
15:15 - 15:45 Coffee Break
Pedro Lima
Liliana Vargas
Carlos Maldonado
Wendy Camelo and All
Deirdre MacCarthy / Natalia Kocancova
Active surveillance in pharmacovigilance including pharmacoepidemiology tools- Arranged by Natalia Kovantova, Prime Vigilance -
Saturday October 26thPre Conference Course 3Biological and biotechnological
product safety- Arranged by -08:00 - 08:30
08:30 - 09:30
09:30 - 10:30
11:00 - 11:30
11:30 - 13:00
Registration.
Global regulations for PV of 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 approaches to effectively apply regulations.
* RMP and biological and biotechnological Controversies: utility in practice, in the clinic, in the regulatory agencies. * The impact of different reference models, FDA vs EMA and WHO.* Explain basis of workshop later on the agenda.
Importance of naming and identifying precisely and accurately suspect biological product of the adverse reaction and its essential place in enabling product safety and quality.
Traceability: What is this and why is it important for monitoring patient safety, effectiveness, quality of life, adherence, etc. What are the systematic challengesand how can we address these barriers?
Gloria Giraldo / Mariano Madurga Sanz
Gloria Giraldo / Carlos Maldonado
Fabio Lievano / Gillian Winstanley / Felix Arellano
Fabio Lievano / Gillian Winstanley / Felix Arellano
10:30 - 11:00 Coffee Break
Saturday October 26thPre Conference Course 3
Biological and biotechnologicalproduct safety- Arranged by -
14:00 - 15:00
15:30 - 16:30
Interchangeability and the role of pharmacovigilance - actual experiences and how canthis be measured?: How as a patient am I involved in the decision on interchangeability?Switch studies.
Event researcher workshop:How do I proceed from the recognition of an adverse event to implementing a risk minimisation measure?How can we assess impact on the patient and the public health? Example Infliximab.
Marco Tuccori
Carlos Maldonado and All
13:00 - 14:00 Lunch Break
15:00 - 15:30 Interactive case.Carlos Maldonado
16:30 - 17:00 Coffee Break
17:30 - 17:40
17:00 - 17:30
Conclusions Workshop.
Patient role and impact public health.Stephan Jarpa
Gloria Giraldo / Mariano Madurga Sanz / Carlos Maldonado
Sunday October 27th
08:00 - 09:00
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.
Break
Lunch
OPENING SESSION. Sten Olsson (President of ISoP)Brian Edwards (UK) Chair ISoP 2019Angela Caro (Colombia) Co Chair ISoP 2019Prof. Carlos Maldonado (Colombia) Claudia Vaca (Colombia)Marie Lindquist (UMC)Shanti Pal (WHO)
Helen Haskell / Evangelina Vasquez
Carlos Aceves González / Yordan Rodríguez
Agnes Kant
Sunday October 27th
14:00 - 14:30
14:30 - 14:50
14:50 - 15:10
15:10 - 15:30
Parallel session A
Dr. Wang presentation. Theatre in indigenous populations and PV.
Cannabis Talk (Regulatory point of view)
Cannabis Talk (Clinical and safe Use)
Abstract oral presentationCurrent status and thoughts about heart injury related to Traditional Chinese Medicine Drugs.
Abstract oral presentationSystematic Instructions for Haematological
Monitoring in Summary of ProductCharacteristics – what constitutes good practice
PLUS BACK UP
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 Break
Coordinator: Jo Barnes
Stephanie Jack (Health Canada)
TBD
Coordinator: Priya Bahri
Juan Miguel Palacios TC
Gillian Winstanley
16:00 - 16:30
17:05 - 17:20
Feedback on UMC seminar about vaccine safety.
Abstract:Vaccines safety in children and in generalpopulation: a pharmacovigilance study on
adverse events following immunization in Italy.
Transcelerate projects in PV.
Abstract:Creation of an Innovation Function in
Pharmacovigilance.
What’s new from North America and EU? Safe use of Vaccines.
Sunday October 27th
Chair: Gloria Giraldo
Jose Vega
Jose Vega, Fabio Lievano, Felix Arellano,Gayatri Jayaraman
(Celgene)
Rebecca Chandler
Alex Dodoo
Chair: Houda Langar
16:30 - 17:05Panel Discussion. Progess with malaria vaccine.
17:30 - 18:00 Musical show at the hotel.
Parallel session C Parallel session D
Monday October 28th
08:30 - 09:00
09:00 - 10:00
Parallel session E
Abstract oral presentation.
Risk management and Signal detection.
PV Education experince of LATAM.Digital approaches to risk minimisation.
Symposium.
Biotechnological and biosimilars drugs.
Challenges in LatinamericanPharmacovigilance.
Parallel session F
10:00 -10:30 Break
Chair: Jean-Christophe Delumeau Chairs: Luis Alesso / Raquel Herrera
Raquel Herrera
Jorge Machado, Javier Uribe, Raquel Herreraand Luis Alesso
Leandro Castillo / Gillian WinstanleyPedro Lima
Mark Perrott
A comparison of cardiology medical devices recall in the United States and the European
Union for 2018.
Application of Qualitative method to detect signals and manage alerts in pharmacovigilance:
Moroccan experience.
Digital tools for the communication of riskminimization measures for medicines.
Discussion.
Monday October 28th
11:45 - 12:30
Parallel session G
Expert Panel discussion on women’s medicines.
Abstract oral presentation.How the Romanian women perceive the
advantages and risks of the contraceptives?
Parallel session H
10:30 - 11:45 Welcome and introduction.
International overview of long-acting reversible contraceptives (LARCs) for women.
Teleconference.
Mifespristone introduction experience.
Women’s Health (SIG).
Panel.
Desafios de la farmacovigilancia “Spanish community” España, Latam y SC in USA.Chair: Mira Harrison-Woolrych
Dr Mira Harrison-Woolrych
Prof Sam Rowlands
Speakers and Ulrich Hagemann
PROFAMILIA: Juan Carlos Vargas,Fidel Ramírez, Andres Reyes
Chair: Angela Caro / Mariano Marduga
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
Impact and Characterization of the DrugRelated Problems Reported by Polymedicated
Inpatients with Prolonged Stays.
Initiative to increase PV awareness and support access to medication for the patient.
12:30 - 13:30 Lunch
13:30 - 14:45 ISoP GENERAL ASSEMBLY.
15:30 - 16:00Abstracts presentation. Abstracts presentation.
14:45 - 15:30
Parallel session I
Brazil:
Mexico:
Africa and Middle East:
Latin America perspective:
Asia:
Impact in real life: are we making a difference? (Industry vision)
Impact in real life: are we making a difference? (Hospital/community vision)
Parallel session J
Chair: Katarina Ilic
Helaine Capucho
Liliana Vargas Neri
Esteban Herrero Martínez
Gillian Winstanley
Jean-Christophe Delemeau
Chair: Marco Tuccori
Monday October 28th
The impact of Pharmacovigilance in Patient Support Programs for Orphan Diseases,
experience in Colombia.
Patient counseling practice among healthcare professionals in Saudi Arabia: its impact on
patient safety.
Differences in Pharmacovigilance RegulatoryRequirements in Latin America countries
(LATAM)
Medication errors and genetic factors aspossible causes of therapeutic failures and
adverse drug reactions in a group of Colombian epilepsy patients.
16: 20 - 17:00
Chapters Session
Africa Chapter.
Middle East:
Latest news about ISoP Chapters.Chair: Brian Edwards
Sten Olsson
Thamer AlShammary
Monday October 28th
16:00 - 16:20 Coffee
Italy Chapter: Marco Tuccori
South East Europe:
Pacific Rim Chapter:
Indonesia:
Katarina Ilic
Mira Harrison-Woolrych
Jean-Christophe Delumeau
17:00 - 17:40
Special Interest Group Session
SIGs Risk Communication, Medication Errors, Women’s Medicines GroupRisk 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 Mc Carthy
20:00 - 24:00 Gala Dinner.
19:00 - 19:30 Transportation to the Gala Dinner venue.
Monday October 28th
Tuesday October 29th
09:00 - 09:30
10:00 - 10:40
11:00 - 11:45
10:40 - 11:00
12:30 - 14:00
09:30 - 10:00
UMC project about signal detection: Strengthening the capacity for signal detection and management for national centres.
Reduction of medication error: the WHO challenge advances (WHO).
CIOMS Update about hepatoxicity and DILI - Lecture.
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
Niklas Noren
Shanti Pal
Hervé Le Louët
Thamer M. AlShammary