International Society of Pharmacovigilance
Israeli Chapter

Team

Executive Committee

Dr. Rina-Irene Fermont, Chairman

Dr. Rina-Irene Fermont, Chairman

Co-founder ISOP ISRAEL, Founder and Director IFC Ltd, Strategic Safety Consulting

Rina Irene Fermont has dedicated her career to patient’s safety. As a physician, Immunohematologist, she started with the setup of the Bone Marrow Graft unit in the Versailles Blood Bank and implemented a first of its kind experience in the Hopital de l’Ouest Parisien: implementing procedures and several autotransfusion techniques, educating the whole staff led to decrease blood transfusions by 50% within a year.

Completing her education with a Master in Bioengineering in Ecole Centrale Paris, she initiated large projects such as turnkey blood banks for developing countries and worked with Hebrew University technology transfer.

For more than 20 years, she created and managed Pharmacovigilance and Risk Management departments or companies at international level. Struck by the crisis she managed with a Low Molecular Weight Heparin, she created the working group on Misuse and Medication Error, gathering Pharmacovigilance centres, industry and authorities, whose results
were included in the French Good Pharmacovigilance Practices, several years before the European guidelines.

Irene is the founder and director of her own consulting company IFC in Israel, France and UK. Pioneering risks prevention, teaching on Risk Management, advocating multisciplinary and system approach, proposing new concepts, her passion led to the creation of the Israeli Chapter of ISOP, the International Society of Pharmacovigilance in 2013. Teaching and conceiving new projects to address unmet medication safety issues are her main drivers, in international congresses, in several countries and in Israel for more than 10 years. She is an active member of the ISOP Working Group on Risk Communication.

Dr Ayala Livneh

Dr Ayala Livneh

Secretary, Co-founder, Ministry of Health, Reference Laboratory, Hadassah Hospital

Presently in charge of quality procedures and ISO accreditation at the Hadassah Ein Kerem Infectious Diseases and Microbiology department, and at the Ministry of Health Central Laboratories in Jerusalem.

Before her alyah in 2015, Dr. Livneh has been the founder and CEO of various companies in the clinical laboratory and biotechnology fields, as well as General Manager or Department Head in two of the main French medical diagnosis groups.

During a significant part of her professional life in France, she has been the sole representative of all private French biology laboratories to the National Reagent Vigilance Committee, directly appointed by the Minister of Health, with attendance to various working groups (watch and innovation, quality control, in-vitro diagnosis devices…).

Steering Committee

Yehudith Wexler

ISOP ISRAEL Audit Committee and Cofounder, CEO Bioforum, ISOP ISRAEL

Yehudith Wexler, Co-founder and CEO of Bioforum Group: Bioforum Applied Knowledge Center, Data Focused CRO and IMP Clinical Supply services (JV with Teva Pharmaceuticals), celebrating its 20th anniversary.

Situated in the heart of the Israeli biotech community, Bioforum aims to improve and enhance the production, safety, quality and efficacy of the biotech industries. For two decades, Bioforum educates the biotech industry’s  professionals and trains the next generation of the clinical trials ecosystem.

Prior to Bioforum Yehudith played a leading role in the establishment of the Medical Devices Unit in the Ministry of Health and worked in major Israeli and international companies.

Yehudith is an avid advocate for the improvement of the clinical trials ecosystem.

Throughout her career she has established several professional networks in the clinical trials space and dedicates of her time to promote their interdisciplinary agendas.

She holds a  MSc from the Weizmann Institute of Science and a Diploma of Information Systems Analyst from the Technion.

Pascal Grin

ISOP ISRAEL Audit Committee, Past CFO Bayer

Pascal Grin is Graduated from ESCP (Ecole Supérieure de Commerce de Paris (Master in Business and Administration) and a Certified Public Accountant (French Expert Comptable).
 Past professional experience: 

  • BAYER Group (HEALTHCARE division)  Chief Financial Officer of Bayer HealthCare France, member of the Executive Board of Bayer HealthCare and of Bayer HealthCare Pharmaceuticals
     

  • THOMSON Group (then THALES) then ST Microelectronics
    Director of Corporate Accounting of ST Microelectronics
     

  • JOHNSON AND JOHNSON FRANCE
    Financial Controller

  • ERNST AND YOUNG
    External Auditor

Associative experience:

  • Member of the Management Committee of “Negba” in Israel. National Board Member of GERME (Management skills), for 6 years.

  • 15 years of membership in numerous professional memberships related to CFO activities

Dr Ophir Lavon

ISOP ISRAEL Steering Committee, Head Clinical Pharmacology and Toxicology, Carmel Hospital, Haifa

Board-certified specialist in internal medicine, clinical pharmacology and toxicology.
Experienced consultant for pharmacology, pharmacovigilance, drug safety, toxicology, biocompatibility, patient safety, risk management, risk assessment, drug and medical device regulation and development 

Dr Gil Mileikowsky

ISOP ISRAEL Steering Committee, President Alliance for Patients Safety, USA.

Dr. Mileikowsky is President and Founder of the “Alliance for Patient Safety” USA,  and “Alliance for Patient Safety” IL, Gil strives to save patients’ lives and physicians’ careers.

He received his MD degree, Cum Laude, at the Catholic University of Louvain – Residency in Ob/Gyn at Baylor College, Houston, Tx and his Fellowship in Reproductive Endocrinology & Infertility at USC in Los Angeles Founding Investor & Director of PillTracker

Dr Hesh Hershman

Treasurer, Forensic Medicine

Coming Soon

Dr Guila Lion

Deputy Director of the Pharmacy, Hospital Mayanei HaYeshua, Bnei Brak

Coming Soon

Scientific Committee

Prof Mati Berkovitch

Head Clinical Pharmacology and Toxicology, Assaf Harofeh Hospital, Safety Advisor for the Ministry of Health.

Prof. Mati Berkovitch is a Pediatrician and a Specialist in medical pharmacology. A member of the academic staff at the faculty of medicine, Tel-Aviv University. Deputy- dean for education matters
for Tel-Aviv University at ‘Assaf Harofeh Medical center. Served as the chairman of the Pediatrics Israeli Association and chairman of the Israeli Clinical Pediatric Association.

Prof. Elliot M Berry

Public Health in the Hebrew University of Jerusalem, Ministry of Health, Geriatric Department, in charge of the campaign of Polypharmacy in elderly People.

My research interests include the sociotype and coping with chronic disease especially concerning weight regulation. I have been a visiting scientist at Rockefeller, MIT, Cambridge and Yale Universities. A former Director of the Braun School of Public Health, the Dept of Human Nutrition and head of the WHO Center in Capacity Building. I was co Editor-in-Chief of the Encyclopaedia on Food Security and Sustainability (Elsevier) and am Chief Editor for Nutrition and Environmental Sustainability.

Prof. Gideon Koren

Prof. Gideon Koren

Director at Motherisk Israel. Senior Scientist, Maccabi-Kahn Institute of Research and Innovation and Ariel University.

Prof Koren is an IsraeliCanadian pediatrician  and a composer of Israeli popular music. After graduating in medicine in Israel, he pursued research in Toronto where he became an International expert in Pediatric Toxicology, Pharmacology and Membrane Biology.

He focused mainly on understanding the complex interactions between drugs and the developing fetus. Professor Koren established the only group worldwide that studies brain development in children exposed in utero to drugs. He tests IQ, language, attention and behavior in children exposed during pregnancy to a large selection of drugs.​

In 1985, Prof Koren founded and directed until 2015The Hospital for Sick Children‘s Motherisk Program in Toronto.

He is the founder of the FACE (Fetal Alcohol Canadian Expertise) Network[25] and founding editor of the peer-reviewed Journal of FAS International (Fetal Alcohol Syndrome).

Among his many achievements and awards, Prof Koren was nominated as: 

Since 1986, Koren has trained physicians from over 30 countries, and over 80 graduate students in pharmacology, making his program the largest worldwide.

Author of 1750 peer review papers and 15 medical books, mostly in the area drug safety, with focus on pregnancy and children. A professor in several Israeli and Canadian universities. All this information has led to major changes in the methods of counseling pregnant women, worldwide.

Prof. Ronen Loebstein

Head of the Pharmacology and Toxicology, Sheba-Tel Hashomer Medical Center

Coming Soon

Prof. Ilan Matok

School of Pharmacy, Hebrew University of Jerusalem

Prof Ilan Matok is a Senior Lecturer in Clinical Pharmacy at the Institute for Drug Research, School of Pharmacy, the Faculty of Medicine of the Hebrew University.

He received his PhD from the Ben Gurion University, Israel. His research focused on the fetal safety of drugs used during pregnancy.

Upon completion of his PhD, Prof Matok started a post-doctoral fellowship in the Hospital for Sick Children (Sickkids) in Toronto, Canada, with Prof Gideon Koren at the division of clinical pharmacology and toxicology.

After completing his post-doctoral fellowship at Sick Kids hospital, Ilan started a post-doctoral fellowship at McGill University and the Jewish General Hospital under the supervision of Prof Samy Suissa from the Centre for Clinical Epidemiology.

His group is studying the use, safety and effectiveness of drugs mainly in special populations (pregnant women, children and the elderly) by using computerized databases and the use of pharmaco-epidemiological research methods and by using advanced methods of meta-analysis.

Dr Gidi Stein

CEO MedAware

A practicing physician, software engineer and entrepreneur.

I have more than 20 years of experience in the IT industry. Served in roles of CTO and Chief Architect of several algorithm-rich startup companies in Israel. In 2002 I graduated Tel-Aviv’s Medical School and later specialized in Internal Medicine, serving as deputy head of an Internal Medicine Ward in Rabin Medical Center, Israel.

I hold a PhD degree in computational biology from Tel-Aviv University, where I teach clinical medicine and molecular imaging.

In 2012 I co-founded MedAware, which developed and patented a disruptive technology that revolutionizes the application of big data in healthcare management. 

International Advisory Board

Prof Hervé Le Louët

CEO of WHO Uppsala International Drug Monitoring Center. Past President, CIOMS*, Past President ISOP, EU Commission Representative in EMA Pharmacovigilance and Risk Assessment Committee

Prof Hervé Le Louët is the new CEO of WHO Uppsala International Drug Monitoring Center,
Past
 President of CIOMS – Council of International Organizations of Medical Sciences established by WHO World Health Organization designing guidelines and standards, basis of all the regulations worldwide.
Prof Hervé has supported the creation of the Israeli Chapter when he was President of ISOP. He is a Member of the ISOP ISRAEL Advisory Board from its creation.

Hervé Le Louët is a Professor of Clinical Pharmacology. He is currently the head of the Pharmacovigilance department of Paris University-Hospitals (AP-HP). He is a hepatologist by training and has a Ph.D. in Pharmacogenetic from the East Paris University.

He is the President of the Council for International Organizations for Medical Sciences (CIOMS) and immediate Past President of the International Society of Pharmacovigilance (ISoP)

He was co-opted member by the European Commission of the Pharmacovigilance Risk Assessment Committee (PRAC) at the European Medicines Agency.

He is a member of the board of the European Network of Centers for Pharmacoepidemiology and Pharmacovigilance (ENCEPP) and is an Honorary Consultant for Uppsala Monitoring Centre (WHO). He was the advisor of the Minister of Health and Social Security.

He worked on liver metabolism assessment in patients with different liver conditions and on the drug-induced mitochondrial toxicity. He also worked on serious cutaneous adverse reactions (SCAR), especially on causality assessment for Steven Johnson Syndrome and Toxic Epidermal Necrolysis. He has learning activities in several universities worldwide.

Dr Michael Cohen

Founder & Director of ISMP, Institute for Safe Medication Practices, ISMP : working with FDA for 35 years to prevent medication errors

Michael R. Cohen, RPh, MS, ScD (hon.), DPS (hon.), is founder and president at The Institute for Safe Medication Practices (ISMP). Dr. Cohen’s passion for medication safety began in 1974 when he was involved in a serious adverse event with insulin in the hospital where he was employed.  He immediately saw the value in sharing his story with other hospital pharmacists to prevent the same error from occurring.  Dr. Cohen founded ISMP in 1994 and launched the first of five ISMP Medication Safety Alert! publications in 1997.  The Newsletters along with Safety Alerts now reach over a million health professionals in the US as well as regulatory authorities and others in over 30 foreign countries. 

Dr. Cohen is active in many patient safety initiatives including co-editor of the ISMP consumer website, Chairperson of the International Medication Safety Network, former member of the US FDA Drug Safety and Risk Management Advisory Committee (DSaRM) and the Nonprescription Drugs Advisory Committee (NDAC) and is currently a consultant to FDA.

Prof. Ronald Litman

ISMP Medical Director, Prof. Pediatric Anesthesiology University Hospital, Philadelphia, appointed FDA Advisory Committee, Chair FDA AADPA,

Ronald Litman, D.O. is Medical Director at ISMP, a pediatric anesthesiologist at The Children’s Hospital of Philadelphia (CHOP) and Professor of Anesthesiology and Pediatrics at the Perelman School of Medicine at the University of Pennsylvania.

He is the Chair of the hospital’s Sedation Committee, the Vice-Chair of the Conflict of Interest Committee, and a member of the Therapeutics & Standards Committee.

From 1991 to 2001 he was Director of Pediatric Anesthesia at Strong Memorial Hospital in Rochester, NY, and returned to Philadelphia in 2001.

He became a crusader for safer medication practices after investigating a fatal medication error in a child during anesthesia. Dr. Litman attended medical school at the NY College of Osteopathic Medicine, completed a residency in pediatrics at Rainbow Babies and Children’s Hospital in Cleveland, OH, anesthesiology residency at Mount Sinai Medical Center in New York, and fellowship in pediatric anesthesia and critical care at CHOP.

Peter Pitts

President, Center for Medicine in Public Interest, past FDA Associate-Commissioner

Peter Pitts is President and co-founder of the Center for Medicine in the Public Interest. Prior to founding CMPI, Pitts was a Senior Fellow for healthcare studies at the Pacific Research Institute.

From 2002-2004, Peter was FDA’s Associate Commissioner for External Relations, serving as senior communications and policy adviser to the Commissioner. He supervised FDA’s Office of Public Affairs, Office of the Ombudsman, Office of Special Health Issues, Office of Executive Secretariat, and Advisory Committee Oversight and Management. He served on the agency’s obesity working group and counterfeit drug task force.

His book, Become Strategic or Die, is widely recognized as a cutting edge study of how leadership, in order to be successful over the long term, must be combined with strategic vision and ethical practice. He is the editor of the new book, Coincidence or Crisis, a discussion of global prescription medicine counterfeiting.

He has served as an adjunct professor at Indiana University’s School of Public and Environmental Affairs and Butler University.

Prof. Nick Sevdalis

King’s College London, Centre for Implementation Science and Patient Safety

An experimental psychologist by training, Nick is a Professor of Implementation Science and Patient Safety, Director of the Centre for Implementation Science at King’s College London, Chief Editor of BMJ Simulation & Technology Enhanced Learning and Associate Editor of Implementation Science. Prior to this appointment, Nick was a Reader in Patient Safety in the Department of Surgery and Cancer at Imperial College London, UK, and Deputy Director of the Imperial Patient Safety Translational Research Centre.

Nick’s research vision is to achieve population health and high quality healthcare delivery through application of psychological and behavioural sciences, including psychometrics, and partnership development between stakeholders in academia, health services, charitable organisations and industry. Nick’s research is situated within the multidisciplinary space of implementation science, improvement science, and applied psychology.

Nick has been investigating team-based care delivery – mainly in surgical and cancer pathways, amongst other clinical services. Nick is interested in the application of team science principles to improve safety and quality of care through improved team effectiveness. His research further focuses on systematically analysing implementation gaps in the delivery of improvement interventions (including checklists, team skills development, and clinical pathway redesign) and developing practical methods to address them.

Nick’s research has been disseminated in over 250 peer-reviewed publications and over 90 invited lectures worldwide, and has won over 25 national and international awards. He serves as an expert advisor to the UK’s Royal College of Anaesthetists Safe Anaesthesia Liaison Group (since 2011). He has previously served on the Board of Directors of the US-based Association for Surgical Education (2013-16) and on numerous trials and study steering groups.