CONFERENCE - Pharmacovigilance without borders - ISOP 2018
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Pharmacovigilance without borders CONFERENCE PROGRAMME #ISoP2018 | www.isop2018geneva.org
VENUE FLOOR PLAN
Cash Bar
Speaker Preview
Room 2
Plenary Hall Exhibition
& Posters
Room 3 Coffee Breaks
Room 4 Registration
Access to 1st Floor
for Lunches
Main Entrance
2 www.isop2018geneva.org
CONTENTS
Welcome Address 4 Social Programme 53
About ISoP 5 Geneva - Amazing Experiences 54
Committee 6 Company Profiles 59
General Information 7 Exhibition Map 63
Supporters 64
Conference Programme
Notes 65
Sunday 11 November 10
Monday 12 November 12
Tuesday 13 November 16
Wednesday 14 November 21
Poster Listing
Session 1 - Poster Presentation
Monday 12 November 24
Session 2 - Poster Presentation
Tuesday 13 November 39
ISoP 2018 • 11-14 November
3
WELCOME MESSAGE
Dear Colleagues,
On behalf of the ISoP Executive Committee and the Local Organizing Committee, it is our
great pleasure to welcome you to the 18th Annual Meeting of the International Society of
Pharmacovigilance (ISoP 2018), “Pharmacovigilance without borders”, in Geneva, Switzerland
from the 11th to 14th November 2018.
Geneva is in the heart of Europe, strategically well positioned in these changing times. In this central
and open environment we wish to continue discussing the importance of pharmacovigilance to health
professionals, as well as to medicines regulatory agencies, scientific organisations, universities, state
authorities and the pharmaceutical industry.
ISoP 2018 meeting will be an opportunity to take stock of current issues in pharmacovigilance, and for
the first time, ISoP members have organised their own conference symposia. This will raise new ideas
for discussion and also allow opportunity to return to some ongoing important issues.
Our aim is to optimise pharmacovigilance, so that it can operate without borders, offering us greater
efficiency, clarity of reporting and thus enable us to analyse the latest information to better care for
patients on a worldwide basis.
As you fly into Geneva it will be clear that you are on the shores of Europe’s largest lake and at the base
of the Alps, only 45 minutes away from the highest peak in Europe. Geneva does not live in the shadow
of its geographical surroundings. It strives to provide a strong multicultural balance, creating a city that
offers a very good homeostasis of outdoor activities and cultural offerings.
Welcome to Geneva!
Sincerely,
Victoria Rollason
Chair of the Local Organising Committee
Co-chair of the Scientific Committee
Sten Olsson
President of ISoP
Ian CK Wong
Chair of the Scientific Committee
Mira Harrison-Woolrych
Co-Chair of the Scientific Committee
4 www.isop2018geneva.org
ABOUT ISoP
INTERNATIONAL SOCIETY ANNUAL MEETINGS
OF PHARMACOVIGILANCE (ESOP AND ISoP)*
ISoP is a global professional, independent, not- ESOP Annual Meetings
for-profit society, open to anyone with an interest 1993 Geneva, Switzerland
in the safe and effective use of medicinal products. 1994 Rouen, France
ISoP aims to foster science, learning and research
1995 Cambridge, England
in pharmacovigilance in all countries.
1996 Lisbon, Portugal
These objectives are met by providing: 1997 Berlin, Germany
> Collegial and convivial support among 1998 Budapest, Hungary
fellow pharmacovigilance professionals 1999 Ankara, Turkey
> An open and impartial forum for sharing 2000 Verona, Italy
experience, knowledge and solutions
ISoP Annual Meetings
> A platform for discussion and generation
2001 Carthage-Tunis, Tunisia
of new research and ideas
2002 Amsterdam, The Netherlands
> Meetings, education and
2003 Marrakech, Morocco
affordable training
2004 Dublin, Ireland
> Regional Chapters and Special
2005 Manila, Philippines
Interest Groups
2006 Liège, Belgium
> Opportunities for networking
2007 Bournemouth, UK
in a friendly environment
2008 Buenos Aires, Argentina
2009 Reims, France
ISoP ADVISORY BOARD 2010 Accra, Ghana
EXECUTIVE COMMITTEE 2011 Istanbul, Turkey
President 2012 Cancun, Mexico
Sten Olsson (Sweden) 2013 Pisa, Italy
Vice President 2014 Tianjin, China
Ian C K Wong (UK and Hong Kong) 2015 Prague, Czech Republic
Secretary General 2016 Agra, India
Mira Harrison-Woolrych (New Zealand) 2017 Liverpool, UK
Treasurer 2018 Geneva, Switzerland
Jean-Christophe Delumeau (Singapore) 2019 Bogota, Colombia
BOARD MEMBERS
Hilda Ampadu (Ghana)
ISoP 2018 • 11-14 November
Brian Edwards (UK)
Deirdre McCarthy (USA)
Jan Petracek (Czech Republic)
Phil Tregunno (UK) * In 2000, the European Society
of Pharmacovigilance (ESOP)
Marco Tuccori (Italy) became the International Society
Hervé Le Louët (France, Past President) of Pharmacovigilance (ISoP).
5
COMMITTEES
LOCAL ORGANISING COMMITTEE
Chair
Victoria ROLLASON, University Hospitals of Geneva (Switzerland)
Committee
Mario Bertazzoli, Helsinn Healthcare Lugano (Switzerland)
Marie Besson, University Hospitals of Geneva (Switzerland)
Jules Desmeules, University Hospitals of Geneva (Switzerland)
François Girardin, University Hospitals of Geneva (Switzerland)
Roseline Ing Lorenzini, University Hospitals of Geneva (Switzerland)
Christian Lovis, University Hospitals of Geneva (Switzerland)
David Niedrig, University Children’s Hospital Zurich and drugsafety.ch (Switzerland)
Frédérique Rodieux, University Hospitals of Geneva (Switzerland)
Stefan Russmann, Klinik Hirslanden Zürich and drugsafety.ch (Switzerland)
Caroline Samer, University Hospitals of Geneva (Switzerland)
SCIENTIFIC PROGRAMME COMMITTEE ORGANISERS
Chair
Ian C K Wong, University of Hong Kong
and UCL School of Pharmacy (UK)
Co-Chairs
Mira Harrison-Woolrych, (New Zealand)
Victoria Rollason, University Hospitals of Geneva (Switzerland)
Committee
Pia Caduff, Uppsala Monitoring Centre (Sweden)
Bruce Donzanti, Genentech, Inc (USA)
Noha Iessa, WHO (Switzerland)
Ambrose Isah, University of Benin City (Nigeria)
Richard Hill, Therapeutic Goods Administration (Australia)
Gurumurthy Parthasarathi, JSS University Mysore (India)
Mónica Tarapues, Central University of Ecuador (Ecuador)
Lynn Zhou, Sanofi (China)
6 www.isop2018geneva.org
GENERAL INFORMATION
VENUE CERTIFICATE OF ATTENDANCE
International Conference Centre Geneva A certificate of attendance will be provided for
17, rue de Varembé all attendees of the pre-conference training course
CH-1202 Geneva and main conference by e-mail. Certificates will
Switzerland be emailed once the online survey has been
completed. A link to the survey will be emailed to
From Geneva Central Station (Cornavin): all attendees on the last day of the conference.
> Bus 5: Departing from the Gare Cornavin
and getting off at the stop Vermont
CLOAKROOM
> Bus 8: Departing from the Gare Cornavin
There is a cloakroom located opposite the
and getting off at the stop UIT
Registration Desk on the Ground Level of the
> Tram 15: Departing from the Gare Cornavin CICG which is open during conference hours.
and getting off at the stop Sismondi It is unmanned. Any items deposited there are
> On foot: Around 20 minutes the responsibility of each individual – the
organisers will not be responsible for any loss
From the Airport: of personal items.
> Bus 5: Departing from the airport
and getting off at the stop Vermont
EMERGENCY PROCEDURES
> By taxi: Around 15 minutes
In the event of an emergency at the CICG,
(depending on traffic)
please follow the instructions from the staff.
ACCOMMODATION In the event of an evacuation of the Convention
Centre, all delegates, exhibitors’ and organisers
For help booking accommodation or if you have
are requested to muster on the esplanade outside
any queries about your hotel reservation, please
the CICG. This is necessary so that we can readily
visit the registration desk where one of the
contact everyone to return to their building when
organisers will be able to assist you.
the emergency is over. Delegates with access
requirements will be guided to the nearest refuge
EXHIBITION, POSTERS point by venue staff, where they will receive
AND COFFEE BREAKS further assistance. No one is to return to the
building until official announcements have been
The exhibition will take place on the Ground made by the CICG.
Level, next to the Poster Area, right behind the
registration area. Refreshments will be served
at the following times:
Date Morning Afternoon
Monday 12 November 10:45 - 11:15 15:30 - 16:00
ISoP 2018 • 11-14 November
Tuesday 13 November 09:45 - 10:00 15:30 - 16:00
Wednesday 14 November 10:00 - 10:30 16:30 - 16:45
7
GENERAL INFORMATION
FIRST AID NAME BADGE
In the event of an accident or an emergency, A name badge will be provided on arrival to
contact a member of the organization at the the congress upon presentation of the relevant
registration. Please be as accurate and as registration documents. The name badge must
concise as possible with any information you be worn at all times and is to be visible both
are providing, especially the exact location inside the meeting rooms and sessions, as well
of the emergency. as at all events organised during the meeting,
including the supporting social programme.
INTERNET ACCESS
Complimentary Wi-Fi is available REGISTRATION TIMES
for all attendees: The main registration desk will be open at the
Network: ISOP2018 following times:
Password: GENEVA
The complimentary Wi-Fi is intended for Date Opening Times
basic browsing only.
Sunday 11 November
08:00 - 18:30
(training courses only)
INSURANCE
The conference organising committee or its Monday 12 November 07:30 - 17:30
agents will not be responsible for any medical
Tuesday 13 November 07:30 - 17:30
expenses, loss or accidents incurred during the
conference. Delegates are strongly advised to Wednesday 14 November 07:30 - 16:30
arrange their own personal insurance to cover
medical and other expenses including accident or
loss. Where a delegate has to cancel for medical GENEVA TOURISM
reasons, the normal cancellation policy will
apply. It is recommended that citizens from EU Geneva Tourism will have an information stand
countries bring with them a current EHIC card. accessible to all delegates for the duration of the
conference. Do not hesitate to visit the stand for
any information about Geneva.
LOST AND FOUND
If you have misplaced any personal items SMOKING AND ELECTRIC
or found an item to hand in, please visit the
registration desk located at the entrance of CIGARETTES
the conference venue. Under Swiss law smoking and vaping are
not permitted in enclosed public places and
MOBILE PHONES workplaces, including hotel bedrooms therefore,
please use designated smoking areas.
Delegates are kindly requested to keep their
mobile phones on silent in all rooms where
scientific and educational sessions are being SOCIAL MEDIA
held, as well as in and around the poster Follow @isoponline on twitter and get all
exhibition area. latest updates. We encourage you to tweet
your highlights during the conference using
hashtag #ISoP2018.
8 www.isop2018geneva.org
SPEAKER PREVIEW TIMES SOCIAL PROGRAMME
The Speaker Preview room is located near Please see page 53 for further details
the cash-bar on the Ground Level and is open on the Social programme.
at the following times:
Date Opening Times
Monday 12 November 07:30 - 17:30
Tuesday 13 November 07:30 - 17:30
Wednesday 14 November 07:30 - 16:30
USEFUL TELEPHONE
NUMBERS
118 for Fire Service
117 for Police
144 for Ambulance
ISoP 2018 • 11-14 November
9
PRE-CONFERENCE PROGRAMME
SUNDAY 11 NOVEMBER 2018
Pre-Conference Course 1 Morning Pre-Conference Course 2 Morning
Pharmacovigilance In Pharmacovigilance
The Aging Population Room 3 In Pre-Approval Phases Room 4
Elderly patients represent a special population Pharmacovigilance science has traditionally been
that requires a special monitoring of drug safety. a discipline focused on the postmarketing or
Polypharmacy, co-morbidities and the age- post-authorisation period, with due attention
related deterioration of physiological functions directed towards pre-clinical safety data, clinical
may contribute to increase vulnerability to trials and adverse events. As the biological
adverse drug reactions in this population. sciences have evolved, pharmacovigilance has
Chairs: Victoria Rollason, University Hospitals shifted toward earlier, proactive consideration
Geneva (Switzerland) / Marco Tuccori, University of risks and potential benefits of drugs in the
Hospital of Pisa (Italy) pre- and peri-approval stages of drug
development, leading to an evolution and
maturing of drug safety and risk management
throughout the lifecycle.
In this one-day course, we will provide examples
of drugs never approved for safety reasons, we
will give practical examples of how collect safety
information during the different phases of drug
development and we will review international
guidelines on pharmacovigilance planning
applicable to the pre-approval phases of
medicines development.
Chairs: Jan Petracek, PrimeVigilance (Czech
Republic) / Bruce Donzanti, Genentech, Inc (USA)
08:30 – 09:00 Registration 08:30 – 09:00 Registration
09:00 – 10:00 Old Age Is No 09:00 – 10:00 Drug Development Stopped
Place For Sissies For Safety Reasons In
Pia Caduff, Uppsala Monitoring Pre-Approval Phases
Centre (Sweden) Mario Bertazzoli, Helsinn
(Switzerland)
10:00 – 11:00 Drugs And Aging: 10:00 – 11:00 Collecting Adverse Drug
Pharmacologist Perspective Reactions In Clinical Trials
Marco Tuccori, University Jan Petracek, PrimeVigilance
Hospital of Pisa (Italy) (Czech Republic)
11:00 – 11:30 Coffee Break
11:30 – 12:30 ADRs From Medication Error 11:30 – 12:30 Development Safety
In The Elderly Population Update Reports
Brian Edwards, Chair Jan Petracek, PrimeVigilance
Pharmaceutical Ergonomics & (Czech Republic)
Human Factors Group (UK)
12:30 – 13:30 Lunch Break
10 www.isop2018geneva.orgPre-Conference Course 1 Afternoon Pre-Conference Course 2 Afternoon
Pharmacovigilance In Pharmacovigilance
The Aging Population Room 3 In Pre-Approval Phases Room 4
13:30 – 14:10 Drug Safety In Elderly Patients: 13:30 – 14:30 Pharmacovigilance Planning
Role Of Co-Morbidities Jan Petracek, PrimeVigilance
And Polypharmacy (Czech Republic)
Stefan Weiler, University
Hospital of Zurich (Switzerland)
14:10 – 14:50 Adverse Drug Reactions 14:30 – 15:15 Approaches To Safety In
In The Elderly: Age-Based Vulnerable Populations
Signal Detection (Including Pregnancy, Children)
Laura Sottosanti, Italian Brian Edwards, Chair
Medicines Agency (Italy) Pharmaceutical Ergonomics
& Human Factors Group (UK)
14:50 – 15:30 Elderly Patients In Clinical
Trials: Status Of The Art
Giovanni Furlan, Pfizer (Italy)
15:30 – 16:00 Coffee Break 15:15 – 15:45 Coffee Break
16:00 – 16:30 Tools To Assess Potentially 15:45 – 16:30 Limits Of Safety Assessment
Inappropriate Prescribing In Clinical Trials: Ethnic, Social
In The Elderly Population And Cultural Factors
Victoria Rollason, University Brian Edwards, Chair
Hospitals Geneva (Switzerland) Pharmaceutical Ergonomics
& Human Factors Group (UK)
16:30 – 17:30 QPPV Role And 16:30 – 17:30 Advancements In
Future Challenges Pharmacovigilance
Lucía Castrillo Soto, Helsinn Pre-Approval Phases
(Ireland) Bruce Donzanti, Genentech, Inc
(USA)
17:30 – 17:45 Wrap-up and Conclusions 17:30 – 17:45 Wrap-up and Conclusions
18:00 – 19:30 Welcome Reception
ISoP 2018 • 11-14 November
11CONFERENCE PROGRAMME
MONDAY 12 NOVEMBER 2018
08:00 – 09:00 Registration
09:00 – 09:30 Opening Ceremony
Sten Olsson, President of ISoP; Ian CK Wong, Chair of the Scientific Committee; Mira
Harrison-Woolrych, Co-chair of the Scientific Committee; Victoria Rollason, Chair of the
Local Organising Committee
WHO-ISoP joint session: PV Coalition of Interested Partners 09:30 – 13:00 Room 2
09:30 – 10:45 Opening session / WHO-ISoP joint session
WHO Coalition of Interested Partners (CIP) initiative
Chair: Clive Ondari (WHO)
Speakers: Viola Macolic (WHO) and Sten Olsson (ISoP)
10:45 - 11:15 Coffee Break & Poster Viewing
11:15 - 12:00 WHO-ISoP joint session (Continued)
Integrating PV in disease programmes / Experience working with multi-stakeholders
in HIV and TB
Chairs: Viola Macolic (WHO) and Ian CK Wong (University of Hong Kong)
Current Status of PV in Botswana and Opportunities for System Strengthening
Stephen Ghanie (Botswana Medicines Regulatory Authority)
Private sector collaboration with National regulatory systems 12:00 – 13:00 Room 2
for PV – Regional Updates
12:00 - 12:10 Africa and Middle East angle
Esteban Herrero-Martinez (AbbVie, UK), on behalf of IFPMA
12:10 - 12:20 Latin America angle
Bruce Donzanti (Genentech Inc., USA), on behalf of FIFARMA
12:20 - 12:30 Asia Pacific angle
Jean-Christophe Delumeau (Bayer, Singapore), on behalf of EFPIA
12:30 - 12:40 Russia/CIS angle
Jean-Christophe Delumeau (Bayer, Singapore), on behalf of EFPIA
12:40 - 13:00 Discussion / Q&A
13:00 - 14:00 Lunch Break
13:00 - 14:00 ISoP Chapter Networking Session Around A Lunch Level 1 Cafeteria
12 www.isop2018geneva.orgSymposium 1 14:00 –15:30 Room 2 Symposium 2 14:00 –15:30 Room 3&4
Taking advantage of new data and technologies The impact of adverse drug reactions on public
to facilitate the collection of safety data and health – how to get relevant and reliable data
to enhance their value for contributing to as the basis for preventive measures and the
decision making assessment of their success?
Chair: Katherine Donegan (MHRA, UK) Chair: Jürgen Beckmann (Germany)
14:00 – 14:20 Additional data sources for 14:00 - 14:25 Measuring the Impact of
supplementing signal detection Adverse Drug Reactions on
Sophie Reeve (MHRA, UK) Public Health – an Overview
of the Methodology
Suzanne McCarthy
(School of Pharmacy, University
College Cork, Ireland)
14:20 - 14:40 Promotion of Digitalized 14:25 - 14:50 O-002 Opportunities and
Pharmacovigilance Technologies Pitfalls when Measuring
towards Protection of Harm Reduction through
Public Health Pharmacovigilance Activities
Phil Tregunno (MHRA, UK) / Florence Van Hunsel
Amin Hussein Al Amiri (The Netherlands
(UAE Ministry of Health Pharmacovigilance Centre
and Protection) Lareb, Netherlands)
14:40 - 15:00 Harnessing the Power 14:50 - 15:05 O-003 Serious Consequences
of Real-World Data for from Medication Errors
Safety Surveillance Identified in Vigibase
Jamie Geier (Pfizer, USA) Alem Zekarias
(Uppsala Monitoring Centre,
Uppsala, Sweden)
15:00 - 15:30 Q&A / Panel discussion 15:05 - 15:30 Discussion
15:30 – 16:00 Coffee Break & Poster Viewing
ISoP 2018 • 11-14 November
13CONFERENCE PROGRAMME
MONDAY 12 NOVEMBER 2018
Symposium 3 16:00 – 17:30 Room 2 Symposium 4 16:00 – 17:30 Room 3&4
Pavia And Proforma; Projects Increasing Teaching Pharmacovigilance To Undergraduates
PV Readiness In Sub-Saharan Africa And Pharmacovigilance Beginners
Chair: Linda Härmark Chair: Eugene van Puijenbroek
(Pharmacovigilance Centre Lareb, Netherlands) (Pharmacovigilance Centre Lareb, Netherlands)
16:00 - 16:20 O-005 PAVIA: Strengthening 16:00 - 16:05 Introduction
Pharmacovigilance in Africa Eugene van Puijenbroek
Frank Cobelens (Amsterdam (Pharmacovigilance Centre
Institute for Global Health Lareb, Netherlands)
& Development)
Ambrose Isah (University of 16:05 - 16:25 Methods For
Benin/University of Benin Undergraduate Education
Teaching Hospital, Nigeria)
Jelle Tichelaar
(VU University Medical Centre
(VUmc), Netherlands)
16:20 - 16:40 O-004 The Proforma 16:25 - 16:45 O-006 What Future Healthcare
Project Presentation Professionals Need To Know
Eleni Aklillu About Pharmacovigilance.
(Karolinska Institute, Sweden) Development Of A PV Core
Curriculum For University
Teaching With Focus On
Clinical Aspects
Rike van Eekeren
(Pharmacovigilance Centre
Lareb, Netherlands)
16:40 - 17:00 Results Baseline Assessment/ 16:45 - 17:00 O-007 Anywhere, Anytime
PVRoad Map 1 – Distance Learning In
Sten Olsson (Karolinska Pharmacovigilance
Institute, Sweden) Anna Hegerius
(Uppsala Monitoring Centre,
Uppsala, Sweden)
14 www.isop2018geneva.orgSymposium 3 (Cont) 16:00 – 17:30 Room 2 Symposium 4 (Cont)16:00 – 17:30 Room 3&4
17:00 - 17:20 Results Baseline Assessment/ 17:00 - 17:15 O-008 Learning By Doing
PVRoad Map 2 – Implementation Of
Abdela Kasso Pharmacovigilance In The
(Food, Medicine and Health Clinical Setting In A National
Care Administration and Control Referral Hospital In Kenya
Authority (FMHACA), Ethiopia) Faith Apolot Okalebo
(Department of Pharmacology
and Pharmacognosy, School
of Pharmacy, University of
Nairobi, Kenya)
17:20 - 17:30 Discussion 17:15 - 17:30 O-009 Long Term And Clinical
Effects Of A Pharmacovigilance
Educational Intervention In
Specialist Oncology Nurses
Michael Reumerman
(VU University Medical Center
(VUmc), Netherlands)
‘Going Further Together’ 17:30 – 18:00 Room 3&4
17:30 -18:00 A film about global medicines safety from Uppsala Monitoring Centre
ISoP 2018 • 11-14 November
15CONFERENCE PROGRAMME
TUESDAY 13 NOVEMBER 2018
Session A 08:30 – 09:45 Room 2 Session B 08:30 – 09:45 Room 3&4
O-010 Communication - The Key To Role Of The Pharmaceutical Industry
Implementation Of Risk Management In Enhancing Pharmacovigilance
And Patient Safety Chairs: Ambrose Isah (University of Benin/
In partnership with the ISoP Special Interest University of Benin Teaching Hospital, Nigeria)
Group for Medicinal Product Risk Communication and Jayesh Pandit (Bayer, Kenya)
(CommSIG)
Chairs: Priya Bahri (EMA, Netherlands), Katarina
Ilich (USA) and Ulrich Hagemann (Germany)
08:30 - 08:35 Welcome And Session Objective 08:30 - 08:40 A Global Overview Of
Pharmaceutical Industry’s
Reports from the UMC
Pia Caduff (Uppsala Monitoring
Centre/UMC, Sweden)
08:35 - 08:42 Risk Communication With 08:40 - 08:53 Perspectives From Africa
Patients – Clear Questions, Jayesh Pandit (Bayer, Kenya)
Clear Responses?
Francois Houÿez
(EURORDIS, France)
08:42 - 08:47 Urgent and important: good
information on medicines
for women worldwide
Bruce Hugman (Uppsala
Monitoring Centre, Sweden)
08:47 - 08:52 O-011 Human factor science 08:53 - 09:06 Perspectives From Asia
for improving the impact of And Middle East
risk communication Mayada Alkhakany (Boehringer
Brian Edwards Ingelheim, United Arab
(Chair Pharmaceutical Emirates)
Ergonomics & Human Factors
Group, UK)
08:52 - 08:57 O-012 Health Care
Communication Empowerment
– a successful programme
in Colombia
Angela Caro Rojas
(Colombian Pharmacovigilance
Association, Colombia)
16 www.isop2018geneva.orgSession A (Cont) 08:30 – 09:45 Room 2 Session B (Cont) 08:30 – 09:45 Room 3&4
08:57 - 09:02 O-013 Central To Risk 09:06 - 09:19 Perspectives From Europe
Communication In Healthcare – Esteban Herrero-Martinez
The National Pharmacovigilance (AbbVie, UK)
Centre In Tunisia
Riadh Daghfous
(Tunisian National Centre
of Pharmacovigilance, Tunisia)
09:02 - 09:07 Risk Management For
Anticoagulants – A Multi-
Stakeholder Project In Israel
Irene Fermont (ISoP Israel
Chapter, Israel)
09:07 - 09:12 Coordinated Communication – 09:19 - 09:32 Perspectives From The US
In Crises And In Everyday Work. Véronique Kugener
Stina Wessling (CIP, Sweden) (Takeda, USA)
09:12 - 09:45 Wrap-Up And Conclusions 09:32 - 09:45 Discussion
09:45 – 10:00 Coffee Break & Poster Viewing
ISoP 2018 • 11-14 November
17CONFERENCE PROGRAMME
TUESDAY 13 NOVEMBER 2018
Session C 10:00 – 11:15 Room 2 Session D 10:00 – 11:15 Room 3&4
Pharmacovigilance Of Medical Devices Benefit Risk Assessment In Pharmacovigilance
Chairs: Jeff Aronson (Centre for Evidence - Based Chair: Jan Petracek
Medicine, UK) and Jitendar Sharma (PrimeVigilance, Czech Republic)
(Andhra Pradesh MedTech Zone /AMTZ, India)
10:00 - 10:15 O-015 What Is A Device? 10:00 - 10:25 Recent Published Failures
Definition And Classification Of Benefit Risk Management
Jeffrey K Aronson Systems – Lessons Learned”
(Centre for Evidence-Based Jan Petracek (PrimeVigilance,
Medicine, UK) Czech Republic)
10:15 - 10:30 What Harms Do Devices Cause? 10:25 - 10:45 Benefit-Risk Evaluation: The Past,
Robin E Ferner (West Midlands The Present And The Future.
Centre for Adverse Drug Juhaeri Juhaeri (Sanofi, USA)
Reactions, UK)
10:30 - 10:45 A Test Case: Adverse 10:45 - 11:05 Quantitative Approaches To
Reactions To Vaginal Mesh Benefit-Risk Assessment
The Patient’s Perspective In Pharmacovigilance: Are We Up
Kath Sansom To The Challenge?
(Sling The Mesh, UK) Ola Caster (Uppsala Monitoring
Centre, Sweden)
10:45 - 11:00 A Test Case: Adverse 11:05 - 11:15 O-016 A Multidisciplinary
Reactions To Vaginal Mesh Management Of Oncologic
The regulatory perspective Patients Treated With Immune
Carl Heneghan Checkpoint Inhibitors (Icpi)
(Centre for Evidence-Based Agnès Lillo-Le Louët
Medicine, UK) (Pharmacovigilance Hospital
European Georges Pompidou,
France)
11:00 - 11:15 Discussion
18 www.isop2018geneva.orgCIOMS Lecture 11:15 – 12:15 Room 2
“New use of clinical concepts in MedDRA: Can MedDRA labelling groupings help to standardise safety labelling?”
Chairs: Hervé Le Louët (President of CIOMS) and Victoria Rollason (Chair of the Local Organising Committee)
Introduction Hervé Le Louët, President of the Council for International Organizations
11:15 - 11:30
of Medical Sciences (CIOMS), France
11:30 - 12:00 Speakers: William Gregory (Pfizer, USA), Sonja Brajovic (FDA, USA), Ilona Grosse-
Michaelis (Bayer, Germany)
12:00 - 12:15 Discussion
12:15 – 13:15 Lunch Break
13:15 – 14:00 ISoP General Assembly
The Bengt Erik Wiholm Lecture and Expert Panel 14:00 – 15:30 Room 2
“Putting Patients First in Pharmacovigilance” Chairs: Mira Harrison-Woolrych (ISoP Secretary General, NZ)
and Linda Harmark (Pharmacovigilance Centre Lareb, Netherlands)
14:00 -14:30 Patient Modulation Of Risks Relating To Medicines Pharmacovigilance Initiatives
For Patients And Their Organisations
Speaker: Francois Houÿez (EURORDIS, France)
14:30 -15:00 O-017 Management of Adverse Experiences from the Use of Herbal Medicines:
The Consumers’ Perspectives
Speaker: Chuenjid Kongkaew (Naresuan University, Thailand)
15:00 – 15:30 Round Table Discussion With International Experts On Patient Perspectives
Panelists: François Houÿez, Chuenjid Kongkaew, Kawaldip Sehmi (IAPO, UK),
George Sabblah (Ghana Pharmacovigilance Centre, Ghana)
15:30 – 16:00 Coffee Break & Poster Viewing
ISoP 2018 • 11-14 November
19CONFERENCE PROGRAMME
TUESDAY 13 NOVEMBER 2018
Symposium 5 16:00 – 17:30 Room 2 Symposium 6 16:00 – 17:30 Room 3&4
Need For A Joined Up Strategy To Optimize Use Promotion Of Pharmacovigilance, As A
Of Medicines For HIV/AIDS, TB, And Diabetes Professional Pharmaceutical Service: The
Chairs: Jing Bao (Frontier Biotechnologies, Inc, Experience Of Joint Work Between Academia,
China) and Brian Edwards Chair (Pharmaceutical Pharmaceutical Associations And The
Ergonomics & Human Factors Group, UK) Pharmaceutical Industry
Chair: Victoria Hall Ramírez (University of Costa Rica,
Costa Rica)
16:00-16:25 O-020 Systems Factors Associated 16:00 - 16:30 O-018 Efforts Made By The
With The Use Of Intravenous University In Costa Rica To
Insulin Infusions – Current Promote Pharmacovigilance
Evidence And Future Directions Victoria Hall Ramírez
Brian Edwards (Chair (University of Costa Rica,
Pharmaceutical Ergonomics Costa Rica)
& Human Factors Group, UK)
16:25 - 16:50 O-021 Strengthening HIV 16:30 - 17:00 O-019 How The Colombian
Pharmacovigilance In China Pharmacovigilance Association
Jing Bao (Frontier Join The Stakeholders In
Biotechnologies, Inc., China) Pharmacovigilance, And Promote
The Best Practices In Latam?
Ángela Caro Rojas
(Colombian Pharmacovigilance
Association, Colombia)
16:50-17:15 O-022 Clinical Application And 17.00-17.30 Discussion
Regulation On Oral Medicines
For Diabetes In China: Current
Status And Further Perspective
Jukai Huang (Dongfang Hospital,
Beijing University of Chinese
Medicine, China)
17:15 - 17:30 Discussion
19:00 – 00:00 Conference Dinner
20 www.isop2018geneva.orgCONFERENCE PROGRAMME
WEDNESDAY 14 NOVEMBER 2018
Symposium 7 08:30 – 10:00 Room 2 Symposium 8 08:30 – 10:00 Room 3&4
Why Do So Many People Receive Treatments Current Challenges In Data Collection
They Do Not Need And What Can We Do About It? On Safety Regarding Drug Use During
Chairs: Ralph Edwards (Uppsala Monitoring Pregnancy And Breastfeeding
Centre, Sweden) and Craig Hartford (Pfizer, UK) Session sponsored by the ISoP Special Interest
Group for Women’s Medicines
Chair: Mira Harrison-Woolrych (ISoP Secretary
General, NZ) and Agnes Kant (Pharmacovigilance
Centre Lareb, Netherlands)
08:30 – 09:00 Adverse Drug Reactions 08:30 - 8:35 The Challenges In Data
Are Caused By Medicines Collection On Safety Regarding
Joan-Ramon Laporte Drug Use During Pregnancy
(Vall d’Hebron University Hospital, And Breastfeeding
Spain) Linda Harmark,
(Pharmacovigilance Centre
Lareb, Netherlands)
09:00 – 09:30 Too Much Alteplase For 08:35 - 8:50 O-024 Opportunities of
Ischemic Stroke? prospective observational
Sir Richard Thompson ENTIS studies
(Royal College of Physicians, UK) Corinna Weber-Schoendorfer
(Charité - Universitätsmedizin
Berlin, Germany)
08:50 - 9:05 O-025 A Population Based
Cohort, Pregnant
Saskia Vorstenbosch
(Pharmacovigilance centre Lareb,
Netherlands)
09:30 – 10:00 O-023 Universal Health 09:05 - 9.20 O-026 Experience With The
Coverage Is Possible with Who Central Registry For The
Effective Pharmacovigilance Epidemiological Surveillance
at Current Expenditure Level Of Drug Safety In Pregnancy
in Nigeria Christine Halleux (WHO)
Emmanuel Okoro (University
of Ilorin, Nigeria) 09:20 - 10:00 Round Table Discussion
10:00 – 11:30 Coffee Break
ISoP 2018 • 11-14 November
21CONFERENCE PROGRAMME
WEDNESDAY 14 NOVEMBER 2018
Symposium 9 10:30 – 12:00 Room 2 Symposium 10 10:30 – 12:00 Room 3&4
O-027 Back To The Future: The Case Narrative Practical Aspects Of Pharmacovigilance In
And Artificial Intelligence Resource-Limited Countries
Chair: Rebecca Chandler (Uppsala Monitoring Chair: Hilda Ampadu (The African Collaborating
Centre, Sweden) Centre for Pharmacovigilance/ACC, Ghana)
10:30 - 10:40 Introduction 10:30 - 10:48 O-029 Enhancing
Rebecca Chandler Pharmacovigilance In
(Uppsala Monitoring Centre, Sub-Saharan Africa: Sharing
Sweden) Experiences From A GSK Pilot
Initiative In Malawi
Olga Menang (PATH)
and Viviane Jusot (GSK)
10:40 - 11:10 O-028 Information On Clinical 10:48 - 11:06 O-030 Strengthening
Reasoning And Heuristics, Pharmacovigilance Capacity For
A Missing Link In Vaccine Manufacturers In Low-
Pharmacovigilance And-Middle-Income Countries
Eugene van Puijenbroek Olga Menang (PATH)
(Pharmacovigilance Centre
Lareb / Netherlands)
11:10 - 11:40 O-033 Distilling The Value 11:06 - 11:24 O-031 Development Of
Of Narratives With Machine Pharmacovigilance System In
Learning A Resource-Limited Country,
Lucie Gattepaille The Experience Of Democratic
(Uppsala Monitoring Centre, Republic Of Congo
Sweden) Didier Nzolo
(National PV Center, Democratic
Republic of Congo)
11:24 - 11:42 O-032 Drug-drug interaction
studies in the field: examples
of South-North collaboration
projects
Andrea Kuemmerle (SwissTPH) /
Samantha Akakpo (MMV)
11:40 - 12:00 Discussion 11:42 - 12:00 Discussion
12:00 – 13:00 Lunch Break
22 www.isop2018geneva.orgCONFERENCE PROGRAMME
WEDNESDAY 14 NOVEMBER 2018
Symposium 11 13:00 – 14:30 Room 2 Symposium 12 13:00– 14:30 Room 3&4
Bringing Together Medication Safety, Human Risk Minimisation Interventions For Diverse Health
Factors And Improvement Science To Achieve Care Systems. Following-Up On CIOMS IX
“Medication Without Harm” Chair: Jean-Christophe Delumeau (Bayer, Singapore)
Chair: Yogini Jani (Centre for Medicines
Optimisation Research & Education, UK)
13:00 - 13:10 Introduction 13:00 - 13:30 O-036 Establishing Criteria
Yogini Jani (Centre for Medicines To Decide The Need For Risk
Optimisation Research & Minimisation Interventions -And
Education, UK) Their Type- Suitable For Diverse
Health Care Systems
13:10 - 13:30 O-034 Similar Sounding Names In Yola Moride (Faculty of
Medications Safety: Risky Or Not? Pharmacy, University of
Yogini Jani (Centre for Medicines Op- Montréal, Canada)
timisation Research & Education, UK)
13:30 - 14:00 0-035 Patient involvement in 13:30 - 14:00 O-037 Addressing the challenges
Adverse Drug Reaction detection affecting the implementation of
and reporting routine risk minimisation and
Rakhi Karwa (Purdue University risk minimisation interventions
College of Pharmacy, USA| Moi in diverse countries.
Teaching and Referral Hospital, On behalf of the SiG Rmin Asia
Kenya) and Mercy Maina (Moi Jean-Christophe Delumeau (ISoP
Teaching and Referral Hospital, treasurer and Bayer, Singapore)
Kenya)
14:00-14:30 Medication Without Harm: 14:00 - 14:30 Panel Discussion CIOMS IX, Four
Is There A Role For Improvement Years After. Moving To The Next Step
Science? Interactive Session Introduced and chaired by
Yogini Jani, Rakhi Karwa, Prof. Hervé Le Louët
Mercy Maina Panelists:Yola Moride, Hervé le Louët,
Jean-Michel Dogne (University of
Namur, Belgium), Stefan Heaton
(Bayer), WHO representative, Chao
Pi Hu (Taiwan Chinese Taipei), Jean-
Christophe Delumeau (Singapore)
14:30 - 16:00 Plenary lecture O-038 “Listening to Kasparov: Putting Human Experts Room 2
and Artificial Intelligence Together to create Advanced Pharmacovigilance”
ISoP 2018 • 11-14 November
Chair: Bruce Donzanti (Genentech Inc., USA)
Speakers: Shaun Comfort (Roche-Genentech PDSS IIDO, USA) and Monica Munoz (FDA, USA)
16:00 - 16:15 Poster Prize Awards Room 2
16:15 - 16:30 ISoP 2019 Presentation And Closing Remarks Room 2
16:30 End Of The Meeting / Tea And Coffee
23POSTER LISTING
284 posters have been successfully accepted for sessions but during the conference on Monday
this year’s 18th ISoP Annual Meeting. Posters will and Tuesday.
be displayed in the exhibition hall area with half
of the posters being displayed on Monday and Official poster session times are:
half on Tuesday.
Date Time
Poster judging will take place during the
conference and the three best posters will be Monday 12 November 10.45 - 11.15
awarded during the poster prize ceremony on 15.30 - 16.00
Wednesday 14 November 16:00 – 16:15. 09.45 - 10.00
Tuesday 13 November
Presenting authors are kindly requested to be 15.30 - 16.00
present throughout the official poster viewing
times (as specified above) but due to the large Assistance for poster mounting / dismantling
number of posters, the Poster Committee will be available at the Poster desk located in
will not only view the posters during the official the exhibition hall area.
SESSION 1 POSTER PRESENTATION MONDAY 12 NOVEMBER
Benefit-Risk Assessment And Risk Management In Pharmacovigilance
Poster No. | Abstract Paper Title Presenter
1 ISoP18-1436
Planning For Implementation Of A Structured Benefit-Risk Framework Within Industry
Abimbola Cole, Takeda Pharmaceuticals, United States
2 ISoP18-1125
The Impact Of A Restrictive Regulatory Action On The Utilization Of Pregabalin Containing
Products In Saudi Arabia
Amal Alshatri Almotiry, Saudi Food and Drug Authority (SFDA), Saudi Arabia
3 ISoP18-1074
Objectives And Design Of The Post-Authorization Studies Evaluating The Effectiveness
Of The Risk Minimization Measures In The Eu Pas Register
Andreea Farcas, University of Medicine and Pharmacy Cluj-Napoca, Romania
4 ISoP18-1086
Process Indicators Vs. Correlated Endpoints In Studies Evaluating The Effectiveness Of Risk
Minimization Measures In The Eu Pas Register
Andreea Farcas, University of Medicine and Pharmacy Cluj-Napoca, Romania
24 www.isop2018geneva.org5 ISoP18-1087
A Description Of Medicines Associated Safety Issues Evaluated Through A Referral Procedure
At The Eu Level
Andreea Farcas, University of Medicine and Pharmacy Cluj-Napoca, Romania
6 ISoP18-1298
Cast Analysis Of Uk Pregnancies Reported During/After Isotretinoin Administration. Proposal
For Application In A Global Safety Study.
Brian Edwards, NDA Regulatory Science LTD, United Kingdom
7 ISoP18-1477
Risk Factors Contributing To Insulin Prescription Errors In A Public Tertiary Care Hospital
In Sub Saharan Africa
Dorothy Atieno Aywak - Aloyo, Kenyatta National Hospital, Kenya
8 ISoP18-1437
Management Of Medication Errors In Pharmacovigilance Centres: Case Of Morocco
Ghita Benabdallah, CAPM WHO CC, Morocco
9 ISoP18-1032
Analysis Of The Risk Management Plans Submitted To The Rational Drug Use And
Pharmacovigilance Department At Jfda (2014-2017)
Jaber Jaber, Jordan food and drug administration, Jordan
10 ISoP18-1303
Consideration Of Benefit-Risk Assessment And Risk Management In Clinical Research
Of Traditional Medicines
Li Zhang, Dongfang Hospital Affiliated to Beijing University of Chinese Medicine, China
11 ISoP18-1174
A Comparison Of Safety-Related Label Changes For Medicines With And Without Major
Objections At Time Of Marketing Authorisation
Lourens Bloem, Utrecht Institute for Pharmaceutical Sciences, Utrecht University,
Dutch Medicines Evaluation Board, Netherlands
12 ISoP18-1085
Risk Minimization Measures Of A Paediatric Orphan Drug For Treatment Of Neonatal Diabetes
Manon Exposito, AMRING, France
13 ISoP18-1404
Practical Aspects Of Developing Relevant Key Performance And Quality Indicators
For Risk-Based Quality Management In Pharmacotherapy.
Marina Alexandrovna Malikova, Boston University, Boston Medical Center, United States
14 ISoP18-1222
In Vivo Tests For Investigating Immediate Hypersensitivity To General Anesthetics
ISoP 2018 • 11-14 November
Mehdi Bouhlel, Tunisian National Centre of Pharmacovigilance, Tunisia
15 ISoP18-1177
A Review Of Benefit-Risk Assessment Over The Product Lifecycle
Milena Miljkovic, PrimeVigilance, Serbia
25POSTER LISTING
16 ISoP18-1183
The Association Between Inappropriate Medication Use And Health-Related Outcomes Among
Nursing Home Residents: A Systematic Review And Meta-Analysis
Pajaree Mongkhon, Faculty of Pharmaceutical Sciences, Naresuan University, University of Phayao, Thailand
17 ISoP18-1152
Is The Risk Of Linezolid To Cause Serotonin Syndrome Real In Routine Clinical Practice ?
Paul M. Tulkens, Université catholique de Louvain, Belgium
18 ISoP18-1341
Anticoagulant Therapy In Patients With Atrial Fibrillation And Risk Of Bleeding: Interim Analysis
- Tyrion Study
Sara Ferraro, University of Pisa, Italy
19 ISoP18-1130
Assessment Of Cyclosporine Blood Concentrations In Adults With Aplastic Anemia
Riadh Daghfous, Clinical and Experimental Pharmacology Research Laboratory LR16SP02,
National Pharmacovigilance center, Tunisia
20 ISoP18-1386
Safety And Efficacy Of Tolvaptan In The Suisse Adpkd Cohort
Stefan Russmann, drugsafety.ch, Swiss Federal Institute of Technology Zurich (ETHZ), Switzerland,
Clinic Hirslanden, Boston University School of Public Health, United States
Global Pharmacovigilance
21 ISoP18-1331
Drug-Induced Anaphylaxis In French And Vietnamese Pharmacovigilance Database 2010-2015:
A Social Pharmacology Discussion
Jean-Louis Montastruc, Centre Hospitalier Universitaire, Faculté de Médecine de l’Université
Paul-Sabatier, France
23 ISoP18-1504
Toxic Epidermal Necrolysis Related To Lamotrigine: About A Case
Amina Tebaa, Moroccan center of pharmacovigilance, Morocco
24 ISoP18-1364
Thyroid Dysfunction After Long-Term Treatment By Amiordarone
Amina Tebaa, Poison and pharmacovigilance center of Morocco, Morocco
25 ISoP18-1510
Development Of Inhibitors In Hemophils A: About Four Case
Amina Tebaa, Moroccan center of pharmacovigilance, Morocco
26 www.isop2018geneva.org26 ISoP18-1202
Reporting Of Qt Interval Prolongation And Torsade De Pointe For Hiv-Antiretrovirals In Vigibase:
Focus On Potential Drug-Drug Interactions
Anne Simon, Swiss Tropical and Public Health Institute, University of Basel, Switzerland
27 ISoP18-1362
Ecopharmacovigilance For Better Health In Ghana
Cynthia Amaning Danquah, Kwame Nkrumah University of Science and Technology, Ghana
28 ISoP18-1064
Pharmacovigilance In Emerging Markets: An Industry Initiative To Strengthen Global
Engagement And Support
Esteban Herrero Martinez, AbbVie, United Kingdom
29 ISoP18-1129
Spontaneous Reporting Of Suspected Adverse Drug Reactions In Patients
With Arthritis: A Scoping Literature And Data Review
Gary Greer, University of Oxford, United Kingdom
30 ISoP18-1078
Tamoxifen And The Risk Of Parkinsonism: A Case Non-Case Study
Jean-Louis Montastruc, Faculté de Médecine - Centre Hospitalier Universitaire, France
31 ISoP18-1118
Risk Of Diabetes Associated With Statins Fibrates And Their Association
Jean-Louis Montastruc, Faculté de Médecine, France
32 ISoP18-1119
Fluoroquinolones And Aortic Aneurysms: What Are The Fluoroquinolones At Risk?
Jean-Louis Montastruc, Faculte de Medecine, France
33 ISoP18-1324
Retrospective Study On Cutaneous Adverse Drug Reactions Induced By Antiepileptic Drugs
Latifa Aït Moussa, cCntre Antipoison et de Pharmacovigilance du Maroc, Morocco
34 ISoP18-1372
Serious Adverse Drug Reactions: Experience From The Moroccan Pharmacovigilance Centre
Latifa Aït Moussa, Centre Antipoison et de Pharmacovigilance du Maroc, Morocco
35 ISoP18-1221
Drug Sefty : In-Vitro Study Of Physicochemical Incompatibilities Of Injectable Antibiotics
ISoP 2018 • 11-14 November
Used In Pediatrics With Other Drugs In An Infusion
Mustapha Bouatia, University Mohamed V, Rabat, Morocco
36 ISoP18-1359
Drug Sefty : Drug Incompatibilities In Intensive Care
Mustapha Bouatia, University Mohamed V, Rabat, Morocco
27POSTER LISTING
37 ISoP18-1256
Acetylsalicylic Acid Adverse Events: A Survey Of General Practitioners
In Democratic Republic Of Congo
Odette Mapipi Mboma, University of Kinshasa, Congo, The Democratic Republic of the
38 ISoP18-1151
Psychiatric Adverse Drug Reactions With Anti-Hypertensive Treatment: Review & Analysis
Of Smpcs
Pipasha Biswas, Symogen Limited, United Kingdom
39 ISoP18-1224
Comparison Of 4 Commonly Prescribed Antipsychotics Patient Information Leaflets
Of Indian Companies With The Original Smpc From Innovator Companies
Pipasha Biswas, Symogen Limited, United Kingdom
40 ISoP18-1460
Factors Associated With Serious Medication Errors In Moroccan Pharmacovigilance
Database From 2006 To 2016
Rachida Soulaymani Bencheikh, Centre Anti Poison et de Pharmacovigilance du Maroc, Morocco
41 ISoP18-1254
Adverse Drug Reaction Reports Following A “Brand Switch”. The New Zealand Experience.
Rhiannon Braund, University of Otago, New Zealand
Miscellaneous
42 ISoP18-1165
Social Media: The Battleground For Public Opinion On Medicines Safety
Alexandra Hoegberg, Uppsala Monitoring Centre, Sweden
43 ISoP18-1354
Reporting Immune Related Adverse Events During Checkpoint Inhibitor Therapy
Anne Leuppi-Taegtmeyer, University Hospital Basel, University Hospital Basel, Switzerland
44 ISoP18-1264
Adherence To Treatment Of Chronic Patients In General Practitioner Office-First Results
Of A Cross-Sectional Survey
Camelia Bucsa, “Iuliu Hatieganu” University of Medicine and Pharmacy, Romania
45 ISoP18-1144
An Example Of Qualitative Signal Detection Within The French Signal Management Process
Claire Ferard, ANSM, France
28 www.isop2018geneva.org46 ISoP18-1497
Risk Perception Of Adverse Drug Reactions By Health Students – Influence Of
Undergraduate Education
Cristiano Matos, Coimbra Health School, Portugal, Faculty of Pharmacy, University of Seville, Spain
47 ISoP18-1416
Reducing Prescribing Errors Associated With In-Patient Electronic Prescribing Systems: An
Investigation Of Pharmacist Interventions
Fahad Alshahrani, University of Birmingham, United Kingdom
48 ISoP18-1412
Exploring Health Professionals Perceptions About Drug Related Problems In Older Patients
Fátima Roque, Research Unit for Inland Development, Polytechnic Institute of Guarda (UDI/IPG), Portugal
49 ISoP18-1297
Impact Of The Doctor-Patient Relationship On Non-Compliance With Pharmacological Medical
Prescription In Chronic Disease. A Cross-Sectional Study
Fátima Roque, Research Unit for Inland Development (UDI/IPG), Health Sciences School,
Polytechnic of Guarda (ESS/IPG), Portugal
50 ISoP18-1299
Factors Of Non-Adherence To Therapy In Chronic Patients With Pathologies Covered By Specific
Legislation In Portugal
Fátima Roque, Research Unit for Inland Development (UDI/IPG), Health Sciences School,
Polytechnic of Guarda (ESS/IPG), Portugal
51 ISoP18-1280
Nurses’ Experiences, Attitudes And Perspectives About Adrs And Reporting In The Netherlands
Gerda Weits, Netherlands Pharmacovigilance Centre Lareb, Netherlands
52 ISoP18-1098
Awareness Survey On Drug-Drug Interactions Among Argentinean Health Care Professionals
Guadalupe Darderes, GADOR S.A., Argentina
53 ISoP18-1117
Pvknow: A Pharmacovigilance Knowledge Management System
Jeltje Boer, Netherlands Pharmacovigilance Centre Lareb, Netherlands
54 ISoP18-1282
The Impact Of Facilitated Reporting Of Adverse Drug Reactions By Health Care Professionals
As A New Source Of Adr Information
Jette van Lint, Netherlands Pharmacovigilance Centre Lareb, Netherlands
55 ISoP18-1133
Framework For Analyzing Consumer Health Questions
Joyce Cao, Herbalife Nutrition, United States
ISoP 2018 • 11-14 November
56 ISoP18-1495
Overview Of Adverse Reactions (Adrs) For Elderly Patients Reported In 2017 In Croatia
Katarina Gvozdanovic, Agency for Medicinal Products and Medical Devices of Croatia, Croatia
29POSTER LISTING
57 ISoP18-1272
Comparison Of Reported Adverse Events Of Premature And Term Born Infants Following
Childhood Vaccinations In The Netherlands
Leontine van Balveren, Netherlands Pharmacovigilance Centre Lareb, Netherlands
58 ISoP18-1094
Expectedness Of Antimicrobials Adverse Drug Reactions In Iraqi, 2010-2017
Manal Mohammed Younus, MOH, Iraq
59 ISoP18-1185
Process Characteristics And Time To Follow-Up Of Adverse Drug Reaction Reports
From A Single Center: A Retrospective Analysis
Matthias Ganso, Department of Medicine, ABDA - Federal Union of German Associations
of Pharmacists, Germany
60 ISoP18-1420
Multiple Drugs Neosensitization Following Dress Syndrome Induced By Cotrimoxazole
Mehdi Bouhlel, Tunisian National Centre of Pharmacovigilance, Tunisia
61 ISoP18-1488
Cetuximab-Induced Acneiform Eruption Resistant To Doxycycline Preventive
And Curative Therapy
Mehdi Bouhlel, Tunisian National Centre of Pharmacovigilance, Tunisia
62 ISoP18-1489
Cerolizumab Pegol-Induced Palmoplantar Pustulosis
Mehdi Bouhlel, Tunisian National Centre of Pharmacovigilance, Tunisia
63 ISoP18-1334
Impact Of Quality And Outcomes Framework On Prevalence Of Chronic Kidney Disease
In United Kingdom
Moninder Kaur, Cognizant Technology Solutions, United Kingdom
64 ISoP18-1377
Adverse Drug Reactions Arising From The Use Of The Products Outside The Terms
Of The Marketing Authorisation
Nikica Mirošević Skvrce, Agency for Medicinal Products and Medical Devices, Croatia
65 ISoP18-1066
What German Physicians Think About The Spontaneous Reporting System And How
They Would Change It. Results Of An Online Survey
Thomas Stammschulte, Drug Commission of the German Medical Association, Germany
30 www.isop2018geneva.orgPatient Involvement In Pharmacovigilance
66 ISoP18-1187
Contribution Of Patient’S Reports In Signal Detection: Experience Of
A Pharmacovigilance Center
Agnès LILLO-LE LOUET, Pharmacovigilance Hopital Européen Georges Pompidou, France
67 ISoP18-1509
Lyell Syndrome With Carbamazépine And Amoxicilline: Clinical Case
Amina Tebaa, Poison and pharmacovigilance center, Morocco
68 ISoP18-1307
Understanding Paediatric Patients’ Pharmaceutical Needs Post Discharged From
A Hospital: An Exploration Study
Asia Rashed, King’s College London, Evelina London Children’s Hospital, Guy’s & St Thomas’
NHS Foundation Trust, United Kingdom
69 ISoP18-1263
Patient Reporting Of Adverse Drug Reactions In Romania-Pilot Phase
Of A Cross-Sectional Survey
Camelia Bucsa, “Iuliu Hatieganu” University of Medicine and Pharmacy, Romania
70 ISoP18-1250
Contribution Of Patients To Pharmacovigilance – The Views Of European Patient Organizations
Cristiano Matos, Faculty of Pharmacy, University of Seville, Spain, Coimbra Health School - IPC, Portugal
71 ISoP18-1128
Monitor The Benefit And Risk Of Medicines In Primary Care; Building A Bridge Between
Daily Practice And Research
Eugene van Puijenbroek, Netherlands Pharmacovigilance Centre Lareb, University of Groningen, Groningen
Research Institute of Pharmacy, Unit of PharmacoTherapy, - Epidemiology & -Economics, Netherlands
72 ISoP18-1430
What Think Older Patients About Their Medicines?
Fátima Roque, Research Unit for Inland Development, Polytechnic Institute of Guarda (UDI/IPG), Portugal
73 ISoP18-1345
Consumers’ Contributions To Pharmacovigilance For Herbal Medicines –Analyses
Of Global Reports In Vigibase®
Florence Van Hunsel, The Netherlands Pharmacovigilance Centre Lareb, Netherlands
74 ISoP18-1415
Patient Knowledge Of Adverse Drug Reaction Reporting
Karamjit Badyal, West Midlands Centre for Adverse Drug Reactions, University of Birmingham,
United Kingdom
ISoP 2018 • 11-14 November
75 ISoP18-1467
Active Surveillance Of Adverse Events Following Immunization (Aefi) Using Both
Paper Forms And Sms
Laura Gonella, University of Verona, Italy
31POSTER LISTING
76 ISoP18-1101
The Degree Of Impact Of Adverse Drug Reactions As Experienced By Patients
Michelle Haaksman, Netherlands Pharmacovigilance Centre Lareb, Netherlands
77 ISoP18-1068
An Ecological Study On Consumer Adverse Event Reporting To The Us Food
And Drug Administration
Monica Munoz, US Food and Drug Administration, University of Florida, United States
78 ISoP18-1496
A Mysterious Resistance To Acenocoumarol!
Riadh Daghfous, Centre National de Pharmacovigilance, Tunisia
79 ISoP18-1492
Adverse Drug Reactions Leading To Ocular Surface Disease Clinic Visits At An Eye Hospital:
A Brief Report
Safa Alizadeh, Tehran University of Medical Sciences, Iran, Islamic Republic Of
80 ISoP18-1053
The Moroccan Phytovigilance System: An Experience Of Involving Patients From 2012 To 2016
Souad Skalli, Faculty of Sciences, Mohammed V University In Rabat, Morocco
81 ISoP18-1056
Chronic Disease Sufferers’ Willingness To Participate In Spontaneous Adverse Drug
Reaction Reporting System
Violeta Getova, Medical University of Plovdiv, Bulgarian drug agency, Bulgaria
Pharmacovigilance And The Pharmaceutical Industry
82 ISoP18-1320
The Impact Of Pharmacovigilance Oversight On Expanded Access Programs (Eaps)
With Nivolumab In Bristol-Myers Squibb Turkey
Belce Cilmi Arslan, Bristol-Myers Squibb Ilacları Inc. Istanbul, Turkey, Turkey
83 ISoP18-1021
Developing A New Methodology For Preparing A Guideline: The Case Of Good
Pharmacovigilance Outsourcing Practices
Brian Edwards, ACRES, United Kingdom
84 ISoP18-1216
Pharmacovigilance In Bioequivalence Studies: Is There A Difference In The Prevalence
Of Adverse Events Between Original And Generic Medicines ?
Mustapha Bouatia, Mohammed V University, Faculty of Medicine and Pharmacy, Morocco
32 www.isop2018geneva.orgPharmacovigilance in Resource-Limited Countries
85 ISoP18-1279
Serious Adverse Drug Reaction Reports In The Nigerian Vigiflow Database
From September 2004 To December 2016
Ali Ibrahim, NAFDAC, Nigeria
86 ISoP18-1173
Vaccine Safety Surveillance In Pregnancy Using Gaia Definitions For Neonatal Conditions:
A Feasibility Assessment In Low- And Middle-Income Countries
Anke L. Stuurman, P95 Epidemiology and Pharmacovigilance Consulting and Services, Belgium
87 ISoP18-1505
The New Pharmacovigilance Guidance In India- Diluted Wine In A Borrowed Bottle
Anupama Ramkumar, Arkus Research Pvt Ltd, India
88 ISoP18-1400
Management Of Individual Case Safety Reports From Multiple Source
In The Drc National Pharmacovigilance Center
ARNOLD NSEKA ZI NSEKA, National Pharmacovigilance Center, Congo, The Democratic Republic of the
89 ISoP18-1267
An Online Collaborative, Open Access Pharmacovigilance Platform
For Resource-Limited Countries
Elizabeth Allen, University of Cape Town, South Africa
90 ISoP18-1161
Online Availability Of Regulatory Documents, Safety Information And Adverse Drug Reaction
Reporting In African Countries
Hanneke Dominicus, Dominicus Medicus Consultancy, Consortium for African Regulatory expertise
Development, Netherlands
91 ISoP18-1045
Drug- Or Herb- Induced Liver Injury In China
Jia-Bo Wang, Beijing 302 Hospital of China, China National Advisory Council of Traditional Chinese
Medicines-Induced Liver Injury, China
92 ISoP18-1403
Pharmacovigilance Intensive During The Administration For Perfusion Of Non-Innovative
Rituximab In The Rebagliati Hospital From March To June 2015
Liz Aliaga, Hospital Rebagliati- EsSalud, Peru
93 ISoP18-1517
Surveillance Of Anti-Tuberculosis Drugs In Thailand
Pakawadee Sriphiromya, Ministry of Public Health, Thailand
ISoP 2018 • 11-14 November
94 ISoP18-1252
Present Status And Future Prospects Of Pharmacovigilance In Nepal
Renu Karki, Pokhara University, Nepal
33POSTER LISTING
95 ISoP18-1507
Pharmacovigilance System In Arabic Countries: A Systematic Review Of 22 Arab Countries
Thamir Alshammari, University of Hail, Saudi Food and Drug Authority, Saudi Arabia
96 ISoP18-1232
The Experience Of Using Khartoum Medicines Information Center (Khmic) As A Focal Point
To Enhance Pharmacovigilance In Sudan
Tsneem Yousef, Ministry of Health Khartoum State, Sudan
97 ISoP18-1262
Opinion Of Costa Rican Pharmacists Regarding A New Adverse Drug Reaction
Reporting Platform, 2017
Victoria Hall Ramirez, University of Costa Rica, Costa Rica
98 ISoP18-1140
Factors Influencing Low Adverse Drug Reaction Reporting Among Healthcare
Professionals In Ghana
Walter-Rodney Nagumo, University Of Sheffield, United Kingdom
99 ISoP18-1512
Implementation Of Medication Errors Reporting Tools In Two Teaching Hospitals In Kinshasa
Yves Lula, University of Kinshasa/National Pharmacovigilance Centre, Congo, The Democratic Republic of the
99.a ISoP18-1054
Frequency Of Regulatory Breach Of Risk Management Plans In Mexico.
Octavio Alejandro Enríquez Lara, Federal Comission for Health Risks Protection, Mexico
99.b ISoP18-1443
Use Of Pharmacovigilance Data Mining For Signal Detection In The Mexican
Pharmacovigilance National Center Spontaneous Reports Database.
Raymundo Castillo Del Valle, Federal Comission for Health Risks Protection, Mexico
Pharmacovigilance Of Medical Devices
100 ISoP18-1321
Reporting Point Side Effects Medical Implants: Experiences After One Year
Carolina Molto-Puigmarti, RIVM, Meldpunt en Expertisecentrum Bijwerkingen Implantaten, Netherlands
101 ISoP18-1035
Herpes Simplex Virus Encephalitis After Deep Brain Stimulation For Epilepsy: A Case-Report
Marylaure GAVARD, Grenoble Alpes University Hospital, France
102 ISoP18-1219
Dress Syndrome Associated With Diclofenac
Ons Charfi, National Centre of Pharmacovigilance of Tunisia, Tunisia
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