Global leader in medication safety, currently president of the International Society of Pharmacovigilance (ISoP), an institution with presence in 100 countries, whose mission is to improve the medication safety worldly.
Pharmacist, Epidemiologist, Ms Pharmaceutical Care, MSc Education. With 20 years of experience, she is an international consultant and lecturer in pharmacovigilance, safe use of medications and medical devices, patient safety, patient education, leadership and communication. Member of Research Ethics Committees, she was president of the Colombian Pharmacovigilance Association for 5 years, founding member and Co-chair of the ISoP Special Interest Group (SIG) “Medication errors”. ISoP SIG Risk Communication and SIG Patient Engagement member. Founding member of Latin American Network of Human Factors and Ergonomics in Healthcare Systems (RELAESA). Currently Pharmacy Career Director in Pontificia Universidad Javeriana.
Dr Edwards trained at Guy’s Hospital, London and spent 14 years in hospital medicine and clinical research before joining the UK regulatory agency which used to be called the Medicines Control Agency. After 5 years there, he joined a global CRO, Parexel, for six years followed by 18 months at Johnson & Johnson as a deputy qualified person for pharmacovigilance.
For the last 13 years up until 2021, he was Principal Consultant in Pharmacovigilance at NDA Regulatory Science based in the UK.
In addition, he co-chairs the ISOP Medication Error Special Interest Group) and Chair of the UK Pharmaceutical Human Factors group.
Previously, he chaired the panel overseeing the ‘Drug Safety Surveillance’ module as part of Higher Medical Training for pharmaceutical medicine in the UK between January 2006 and 2012. He has been awarded a Fellowship with the International Society of Pharmacovigilance.
Currently he is Managing Director of his own consultancy Husoteria Ltd and has been co-leader of the DIA/ASA Benefit Risk Assessment Planning working group since 2020. More recently, he was elected back to the Executive Committee of ISOP and is Vice-President of ISOP and Director of ISOP Secretariat Ltd.
In May 2023 he was awarded a Global Fellowship in Medicines Development.
A/Prof Geraldine Moses AM is a Doctor of Clinical Pharmacy specialised in Medicines Information. She works part-time in the Medicines Information Service at the Mater Hospital in Brisbane, but her main job is as consultant pharmacist to the Australian Dental Association, for whom she provides a national drug information service, writes regular articles, and presents education and podcasts. Geraldine also holds the position of Adjunct Associate Professor in the Schools of Pharmacy at the University of Queensland, QUT and the Dental School at UWA. She also consults to organisations such as the Department of Veterans Affairs, the Commission for Safety and Quality in Healthcare and the Qld Office of the Health Ombudsman.
Throughout her pharmacy career, Geraldine has held a strong interest in Pharmacovigilance and medication safety. During her doctoral research on Pharmacovigilance, she established and operated the NPS Adverse Medicine Events line, through which thousands of suspected adverse Drug reactions were reported by the general public and passed on to the TGA.
Dr Grace Wangge is a medical doctor and epidemiologist, teaching in the field of Public Health and Public Health Policy. She got her medical degree from Universitas Indonesia, Indonesia and PhD from Utrecht Universiteit in the Netherlands in the field of Pharmacoepidemiology. She also had a postdoctoral fellowship with Harvard Medical School/Brigham and Women’s Hospital, Boston, USA.
Since returning to Indonesia in 2014, she has developed research expertise in community medicine, community nutrition, public health policy and pharmacovigilance. She also has years of experience in research and capacity building at the grassroots level, as well as evaluating the implementation of health and nutrition programs in primary health services in Indonesia.
Helen Byomire Ndagije, a pharmacist and clinical epidemiologist is the Director of Product Safety at the National Drug Authority in Uganda. She is the President of the Africa Chapter of the International Society of Pharmacovigilance (ISoP), holds a masters in business administration and a doctorate in public health. She is known for having introduced a decentralised system of pharmacovigilance in Uganda. She has also been the Vice Chairperson of the African Vaccine Regulator’s Forum(AVAREF) , a network that has recently seen the regulatory system for clinical trials of medicines and vaccines uplifted in the region. She is a member of the Patient Engagement Special interest group of ISoP. She gives pharmacovigilance lectures to undergraduate, masters and post-graduate students and supervises doctorate students in pharmacovigilance.
Office : – Institute of Forensic Sciences and Criminology Udayana University Denpasar Bali, Indonesian
– Department of Pharmacy Faculty Mathematic and Basic Sciences Udayana University
Qualifications and affiliations :
1987 – 1992 Undergraduate Pharmacy at Institute of Technology Bandung (ITB) – West Java, Indonesia
1992 – 1993 Pharmacist (Apotheker) at Institute of Technology Bandung (ITB) – West Java, Indonesia
1995 – 1997 Master Pharmacy at Institute of Technology Bandung (ITB) – West Java, Indonesia
2000 – 2004 Doctor of Natural Sciences in Field Forensic Toxicology – at Institute of Pharmacy, University Hamburg, Germany and at Institute of Forensic Medicine, George August University – Goettingen, Germany
2000 – 2004 Young Scientist Researcher in Field Forensic Toxicology at Institute of Forensic Medicine, George August University – Goettingen, Germany
2004 – now Senior Lecture in Pharmacy Department – Faculty of Mathematics and Natural Sciences – Udayana University
2018 – bow Expert advisor of Governor Bali in Field Balinese Traditional Medicine and Balinese Wellness
Dr. Raoh-Fang (Jasmine) Pwu, PhD, is the CEO of the Data Science Center at Fu-Jen Catholic University and currently holds the position of adjunct Assistant Professor at Taipei Medical University. She completed her training as an epidemiologist at the College of Public Health, National Taiwan University, where she developed expertise in research designs and the analysis of large/claims databases early in her career. Along her research path, she discovered a keen interest in economic evaluations in healthcare, which led her to pursue a career in this field.
In 1999, Dr. Pwu, along with several colleagues from her college, co-founded a consulting company specializing in clinical/epidemiological research design and data analysis. However, her career took a turn in 2007 when the Taiwanese government approached her to join the project of developing a health technology assessment (HTA) system in Taiwan. She accepted the opportunity and began working for the Division of HTA at the Center for Drug Evaluation. Since assuming this role, she has been instrumental in developing a robust HTA system and conducting research. In 2009, she became the Director of the HTA Division.
In 2016, Dr. Pwu was recruited by the Ministry of Health and Welfare (MOHW) to serve as the Director of the National Hepatitis C Program Office in Taiwan. She held this position until 2023, during which significant progress was achieved.
Dr. Pwu has actively contributed to the field of HTA at both national and international levels. She served on the INAHTA Board from 2010 to 2012 and, together with her HTA colleagues from Thailand and Korea, founded HTAsiaLink in 2010, where she assumed the role of President from 2014 to 2016. Furthermore, she has been a member of ISPOR (International Society for Pharmacoeconomics and Outcomes Research) since 2001 and served as a Board of Director for three years (2018-2021).
Dr Joanna Hikaka (Ngāruahine) is a pharmacist and Senior Research Fellow at the University of Auckland, New Zealand. Her clinical and research work focuses on older adult and Māori health, spanning primary, secondary, and aged residential care settings. Joanna is a Co-director of the newly established Centre for Co-Created Ageing Research at the University of Auckland and holds a number of regional and national governance and advisory roles relating to the responsible use of medicines, gerontology, and aged residential care. She is a Fulbright Scholar and previous winner of New Zealand Pharmacist of the Year (2019) and
Jo Barnes is Professor in Herbal Medicines and Deputy Head of the School of Pharmacy in the Faculty for Medical and Health Sciences at the University of Auckland in New Zealand. Jo is the chapter lead for the Western Pacific chapter of the International Society of Pharmacovigilance, and was the founding chair of the Herbal and Traditional Medicines special interest of ISoP (2017-2022). Jo was a member of the Executive Committee of ISoP (2006-2009).
Senior Research Fellow of the Ateneo Policy Center, School of Government, Ateneo de Manila University. Former Undersecretary of Health and Director General of the FDA Philippines. Internist-Toxicologist by training.
Dr. Manal Younus is currently the head of the Iraqi Pharmacovigilance Center based in MOH. Manal is a pharmacist with a Ph.D. in clinical pharmacy. She led the creation and expansion of the Iraqi pharmacovigilance system. Currently, she is an International Society of Pharmacovigilance (ISoP) fellow and ISoP Advisory Board member, working with students to increase awareness regarding pharmacovigilance. She is an Executive Committee member of the Council of International Organizations of Medical Sciences (CIOMS). Manal is the co-founder of the ISoP Patient Engagement SIG, the vice president of the ISoP Middle East chapter, and a member of both the ISoP Risk Minimization SIG and the ISoP Pharmacovigilance Professional Qualification Framework SIG. She had authored more than 40 articles on different drug safety-related subjects. She is a WHO bench-marking assessor. Finally, a member of the International Academy of Public Health’s (IAPH) Scientific Council and Antimicrobial Resistance Specialty Committee.
Mandeep joined the MHRA in 2008 as a Good Clinical Practice (GCP) Inspector and
performed more than 150 inspections. Notably, leading EMA inspections associated with
marketing authorisation applications, in conjunction with other regulators, such as ANSM,
HPRA and PEI, at sites in the UK as well as Australia, Croatia, Germany, India, Malawi, and Tanzania.
As Head of the MHRA Pharmacovigilance Inspectorate from 2013 to 2020, Mandeep was responsible for managing the Pharmacovigilance inspection team and the UK pharmacovigilance inspection programme, as well as developing relationships with key
regulatory partners, such as the US FDA.
In addition, Mandeep chaired the international PIC/S GCP & GVP Inspectors Working
Group, was responsible for managing the global joint visit programme and supported
pharmacovigilance inspection training initiatives for NMPA (China), NPRA (Malaysia) and
After a 12-year career at the MHRA, Mandeep joined Kyowa Kirin, a Japan-based specialty pharmaceutical company, as the Global Head of Pharmacovigilance Audits and Inspections, and has responsibility for readiness strategy, audit and inspection CAPA management and regulatory intelligence.
Mandeep has a BSc (Hons) in Pharmacology from King’s College London and is studying for an MSc in Public Health.
Dr. Mayada Alkhakany is a highly accomplished healthcare professional with an impressive track record of success in the pharmaceutical industry. Currently serving as Regional Healthcare Affair, Innovation, Patient Engagement Manager at Boehringer Ingelheim in the United Arab Emirates, she brings a wealth of experience to her role
Prior to her current position, Dr. Alkhakany held several other key positions at Boehringer Ingelheim, including Global Senior Non-Trial Activities Manager, where she led the review committee on a global level to approve non-trial projects. She also served as the head of pharmacovigilance in the Middle East, Turkey, and Africa, where she was responsible for ensuring patient safety across the region.
Before joining Boehringer Ingelheim, Dr. Alkhakany worked as an Associate Director of Pharmacovigilance at Merck Sharp & Dohme. She has also held various other positions with MSD, including Medical Advisor and Clinical Research Project Manager.
Dr. Alkhakany is a recognized leader in the field of pharmacovigilance and patient engagement. She is an Advisory board member of ISoP (International Society of Pharmacovigilance) for the 2023-2026 term and is the founder and chair of the ISoP Patient Engagement Group. She is also a co-founder and ex-president of the ISoP Middle East chapter and served as the chair of the local organizing committee for the annual meeting of ISoP in 2021. Additionally, Dr. Alkhakany is an active member of ISPOR (International Society for Pharmacoeconomics and Outcomes Research) in the patient engagement and digital solution groups.
Dr. Alkhakany holds a bachelor’s degree in Dentistry from Baghdad University in Iraq and has completed numerous international training programs in medical affairs, clinical research, business foundation, leadership, healthcare assessment tools, and coaching.
Throughout her career, Dr. Alkhakany has demonstrated a strong commitment to patient safety, innovation, and engagement. Her contributions to the pharmaceutical industry have been significant, and she is widely recognized as a leader in her field.
Safety Officer, and is based in Montreal, Canada. He is an Executive Committee member and Treasurer of the International Society of Pharmacovigilance (ISoP), Leader of the Medical Device Safety – Special Interest Group (SIG) and serves on the NASoP Executive Committee as the Coordinator of Membership.
He previously held leadership roles in pharmaceutical companies in Europe and Canada. He holds a Degree in Pharmacy and PhD in Pharmacology from Algiers University, Algeria and a Master in Pharmacovigilance and Drug Safety from Paris Descartes University, France.
Omar has presented in multiple scientific forums with interest in new technologies and the improvement of pharmacovigilance around the world.
Priya Bahri, PhD, FISoP is the lead for Pharmacovigilance and Risk Management Guidance and Policies at the European Medicines Agency (EMA). In her role at EMA, she is also the editor of the EU good pharmacovigilance practice guidelines (EU-GVP), and she currently focusses on new approaches for stakeholder engagement to support regulatory decision-making and implementation of risk minimisation measures in healthcare. She has wide experience in the coordination of the European Union regulatory pharmacovigilance network, stakeholder interactions, and international collaboration at the level of WHO, CIOMS and the International Council of Harmonisation (ICH).
Before joining EMA in 1996, she had gained work experience in hospital and community pharmacies as well as in projects for associations of physicians in the public insurance system and for the German international development agency GTZ. Her background consists of a degree in pharmacy (University of Heidelberg), a post-graduate diploma in epidemiology & biostatistics (McGill University), and a PhD (Humboldt University Berlin with research at University Utrecht) on quality management for patient safety. She holds further post-graduate certificates in strategic health communication (Johns Hopkins University) and global health diplomacy (Graduate Institute Geneva).
As pro bono activities, she was lecturer for the previous master study programme Consumer Health Care at Humboldt University Berlin and now provides advice and lectures to the Utrecht Centre for Pharmaceutical Policy and Regulation as affiliated researcher. She was awarded as Fellow of the International Society of Pharmacovigilance (ISoP) and is also active in the International Society of Pharmacoepidemiology (ISPE). She is the editor of the book “Communicating about Risks and Safe Use of Medicines: Real Life and Applied Research” published by Springer in 2020.
Dr. Steven Black is a pediatric infectious disease specialist who received degrees in Biology and Chemistry from the University of California Santa Barbara and an MD degree from the University of California San Diego. He completed a fellowship in pediatric infectious diseases at the University of California San Francisco. He has spent more than 30 years conducting clinical trials and safety studies of vaccines including being the principal investigator in five pivotal licensure trials and six phase four post marketing trials. He has also conducted numerous phase 1-2 clinical trials. He is co-Director of the 25 country Global Vaccine Data network currently engaged in the safety evaluation of COVID-19 and other vaccines. He is work package lead for DSMB activities for the CEPI funded SPEAC project supporting the assessment of vaccine safety in CEPI funded clinical trials. He is currently Emeritus Professor of Pediatrics at the University of Cincinnati Children’s Hospital in Ohio USA and Honorary Professor of Pediatrics at the University of Auckland in New Zealand. He is editor in chief of the Pediatric Infectious Disease Journal.
Prof. Rahman is in Pharmacology for more than 2 decades. He published 7 books, 17 chapters and more than 200 papers in various journals. He edited 11 periodicals and delivered/chaired more than 200 lectures as guest speaker and resource person. He attended 80 Workshops/Training Programs and presented papers during 90 International and 105 National Conferences. He organized 3 international conferences/CMEs and 22 national conferences/symposiums/CMEs and handled 7 academic projects. After MD (Pharmacology), he obtained PhD from Western Sydney University, Australia. With his initiative, PhD programme was started in the Department of Pharmacology, Aligarh.
He reported several ADRs and gave the concept of Environmental Pharmacovigilance. The term, ‘Pharmacoenvironmentology’ in relation to Environmental Pharmacovigilance was coined by him in 2006. He served the Society of Pharmacovigilance, India (SoPI) in various capacities. He started Journal of Pharmacovigilance & Drug Safety. Currently serving the Society as National Secretary. Indian Pharmacopoeia Commission nominated him as Coordinator of AMC-PvPI and MDMC-MvPI at JNMC, AMU, Aligarh. Being a member of ISoP, he takes interest in the Special Interest Group of Ecopharmacovigilance as well as Herbal and TM.
While working on morphine de-addiction properties, he proposed modified method for moderately and severely induced morphine dependent rats. He specifically screened Delphinium denudatum and Myristica fragrans for its protective activity in morphine induced physical dependence. Four of his MD candidates expanded the same work. He is the co-founder of Ibn Sina Academy of Medieval Medicine & Sciences for which he bequeathed his ancestral property worth millions of Indian Rupees. The Academy is designated as Centre of Excellence by Ministry of AYUSH, Govt. of India and listed in the Directory of History of Medicine, NLM, USA.
He received International Postgraduate Research Scholarship to pursue PhD from Australia. The same university decorated him with International Alumni Leadership Award. He was invited to serve as member jury panel to select Science Scholars Awards of Sun Pharma Science Foundation. He is member of 40 learned educational bodies including recipient of Fellowship of International Medical Sciences Academy (FIMSA), National Academy of Medical Sciences (MAMS/FAMS) and IMA Academy of Medical Specialities (FIAMS).
Viviane Jusot is currently Project lead at GSK Vaccines Wavre, Belgium, coordinating the project aimed to enhance Pharmacovigilance infrastructure in Sub-Saharan Africa (SSA).
Trained in pharmaceutical medicine, clinical research, epidemiology, virology and project management, Viviane has more than 25 years of experience in successfully managing PV, clinical, epidemiology and laboratory science projects within the pharma industry, the university environment, with national governments and the humanitarian sector; and for a wide range of communicable diseases in SSA, Latin America, Europe and USA.