The United States Food and Drug Administration (FDA)
Lubna Merchant, PharmD, MS: Dr. Merchant currently serves as the acting Director of the Division of Medication Error Prevention and Analysis. She is also the Deputy Director of the Office of Medication Error Prevention and Risk Management in FDA’s Center for Drug Evaluation and Research (CDER) where she is responsible for the Center’s programs in risk management and medication error prevention. She provides expertise on development and implementation of programs and initiatives to support the Center’s policies related to Risk Evaluation and Mitigation Strategies (REMS). She serves as expert/scientific advisor on medication errors associated with drug and biological products within the Center and outside agencies. Dr. Merchant graduated from Massachusetts College of Pharmacy and Health Sciences with Master of Science in Industrial Pharmacy and Doctor of Pharmacy and completed a PGY1 Pharmacy Practice Residency. She has worked in a variety of health care settings including retail pharmacy, industry and hospital pharmacy as an inpatient pharmacist and as a clinical specialist.
Janet Woodcock, MD: Dr. Woodcock is Director of the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA). She joined FDA in 1986. Dr. Woodcock first joined CDER in 1994. From 2005 until 2008, she served in the FDA’s Commissioner’s office, holding several positions, as Deputy Commissioner and Chief Medical Officer, Deputy Commissioner for Operations, and Chief Operating Officer. Her responsibilities encompassed oversight of various aspects of scientific and medical regulatory operations. Dr. Woodcock received her M.D. from Northwestern Medical School. Prior to that, she completed further training and held teaching appointments at the Pennsylvania State University and the University of California in San Francisco.
Danielle Harris, PharmD, BCPS: Dr. Harris serves as the Deputy Director of the Division of Medication Error Prevention and Analysis in the Office of Surveillance and Epidemiology (OSE). Dr. Harris has over 10 years of drug safety experience and in her current role she provides oversight of the pre- and post-marketing safety activities related to drug nomenclature, labels, labeling, packaging, and product design to mitigate the risk of medications errors for drugs and biologic products regulated by CDER. She received her Doctor of Pharmacy degree from Northeastern University, after which she completed an ASHP accredited pharmacy practice residency at Beth Israel Deaconess Medical Center in Boston. Prior to joining FDA, she held the role of Quality and Safety Coordinator at Glens Falls Hospital.
Irene Chan, PharmD: Dr. Chan holds the rank of commander (CDR) in the US Public Health Service. CDR Chan currently serves as Deputy Director in the Division of Medication Error Prevention and Analysis (DMEPA), responsible for leveraging her knowledge of regulatory principles, human factors, and risk management to provide oversight of safety recommendations regarding drug nomenclature, labels, labeling, packaging, and product design. CDR Chan is committed to increasing the safe use of drug products by minimizing drug usage error that is related to naming, labeling, packaging, or design. CDR Chan received her B.S. in Pharmacy and Doctor of Pharmacy degree from Rutgers University Ernest Mario School of Pharmacy and she completed a PGY1 Pharmacy Practice Residency at Gallup Indian Medical Center. Prior to coming to FDA, CDR Chan worked with the Indian Health Service (IHS), and her responsibilities included chairing a multidisciplinary medication safety task force, serving as a supervisor of inpatient pharmacy services, and serving as the pharmacy residency program director. While stationed in New Mexico, CDR Chan also worked closely with the New Mexico Pharmacists Association (NMPhA), serving in various leadership positions within the state association.
Claudia Manzo, PharmD: Dr. Manzo serves as the Director of the Office of Medication Error Prevention and Risk Management, Office of Surveillance and Epidemiology (OSE). Dr. Manzo has 20 years of drug safety experience and in her current role directs review staffs that advise Risk Evaluation and Mitigation Strategies (REMS), Proprietary Names, Human Factors Studies, and Medication Errors for drugs and biologic products regulated by CDER. She received her Doctor of Pharmacy degree from the University of Tennessee, after which she completed a residency in clinical pharmacy practice at the Regional Medical Center in Memphis and a fellowship in Nutrition Support at the Philadelphia College of Pharmacy and Science. Prior to joining FDA, she was a clinical pharmacist at Walter Reed Army Medical Center and a pharmacy officer in the US Army.
Ilisa B.G. Berstein, PharmD, JD: Dr. Bernstein is the Deputy Director of the Office of Compliance in the Center for Drug Evaluation and Research (CDER). She leads this Office in promoting and protecting public health through outreach, strategies, and actions that minimize consumer exposure to unsafe, ineffective, and poor quality drugs. From 2006 to 2010, Dr. Bernstein was the Director of Pharmacy Affairs at FDA and from 1991-2002 and 2003 to 2006, she was a Senior Advisor in the Office of the Commissioner. From 2002 to 2003, Dr. Bernstein was a Senior Associate Director at Pfizer in the Regulatory Liaison Office in Rockville, Maryland. Dr. Bernstein began her career at FDA in 1988 as a Pharmacokinetic Reviewer in CDER. Dr. Bernstein completed a post-doctoral residency at the National Institutes of Health, focusing on clinical and research pharmacokinetics. Dr. Bernstein received her Doctor of Pharmacy degree from The University of Michigan College of Pharmacy and her Juris Doctor (JD) from The American University Washington College of Law.
Sonja Brajovic, MD: Dr. Brajovic is a Medical officer in the Office of Surveillance and Epidemiology (OSE), Center for Drug Evaluation and Research (CDER). She is responsible for monitoring Medical Dictionary for Regulatory Activities (MedDRA) coding quality of reports in the FDA Adverse Event Reporting System (FAERS). Dr. Brajovic represents FDA on the International Conference on Harmonization (ICH) MedDRA Points to Consider workgroup and the Council for International Organizations for Medical Sciences (CIOMS) Implementation workgroup on Standardized MedDRA Queries (SMQs).
Jo Wyeth, PharmD: Dr. Wyeth is the Postmarketing Surveillance Program Lead in the Division of Medication Error Prevention and Analysis (DMEPA), Office of Surveillance and Epidemiology (OSE), Center for Drug Evaluation and Research (CDER). She oversees postmarketing efforts related to collecting and analyzing medication error reports, communicating safety issues, establishing partnerships, training, and research to support drug safety regulatory activities. She is also the lead for the DMEPA Rapid Response Team and represents DMEPA on several internal and external workgroups.
The Institute for Safe Medication Practices (USA)
Michael R. Cohen, RPh, MS, ScD (hon.), DPS (hon.): Mr. Cohen is president of The Institute for Safe Medication Practices (ISMP), a non-profit healthcare organization that specializes in understanding the causes of medication errors, providing error-reduction strategies to the healthcare community, policy makers, and the public. Cohen serves as co-editor of the ISMP Medication Safety Alert! publications that reach over 2 million health professionals in the US as well as regulatory authorities and others in over 30 countries. He is also co-editor of the ISMP consumer website, www.consumermedsafety.org. Cohen is the Chairperson of the International Medication Safety Network (IMSN - www.intmedsafe.net), which develops guidance to minimize preventable harms from medicine use in practice. He has served terms on 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. Among recognitions he has received, he is a recipient of the John M. Eisenberg Patient Safety and Quality Award from the National Quality Forum and the Joint Commission, the Harvey A. K. Whitney Award from the American Society of Health-System Pharmacists and he has also been recognized as a MacArthur Fellow by the John D. and Catherine T. MacArthur Foundation.
The World Health Organization (WHO)
Shanthi Pal, B.Pharm, M.Pharm and PhD in Pharmacology: Group Lead (Medicines Safety), Safety and Vigilance, Department of Essential Medicines and Health Products, World Health Organization, Geneva, Switzerland. She also holds multiple titles as the Secretary of the WHO Program for International Drug Monitoring, Secretary of the WHO Advisory Committee on Safety of Medicinal Products, Secretary of the International Working Group for Drug Statistics Methodology, Board Member, Uppsala Monitoring Centre, WHO Nominee, ICMRA Big Data and Pharmacovigilance sub-working groups and WHO Nominee, ICH Expert Working Group (E19) on Optimization of Safety Data Collection. Her responsibilities include managing the WHO Medicines Safety Program and the relevant Collaborating Centres for the Program, promoting global exchange of information on medicines safety and regulatory decisions, supporting the development of norms and standards in pharmacovigilance, and their application in low-middle income countries (LMIC), building partnerships for pharmacovigilance with public health program and global health initiatives such as the Gates Foundation, Global Fund, Medicines for Malaria Venture (MMV) and UNITAID and mobilizing resource for pharmacovigilance in LMIC.
Medicines and Healthcare Regulatory Agency (United Kingdom)
Jan Macdonald: Jan MacDonald is a pharmacist by profession and is currently Group Manager for the Access, Information for Medicines & Standards Group in the Vigilance and Risk Management of Medicines Division at the MHRA. A key aspect of her role is safe packaging and quality information for healthcare professionals and patients. Jan has undertaken assessment and management roles within the agency. Prior to this she was principal pharmacist for quality assurance and quality control in the National Health Service.
The Institute for Safe Medication Practices (ISMP-BRASIL)
Lisiane Leal: Lisiane Leal is currently a consultant of ISMP Brasil as a member of the workgroup which is reviewing the labeling and packaging legislation in Brasil. She is also a PhD candidate in Epidemiology at the Universidade Federal do Rio Grande do Sul. Lisiane worked during nine years as a hospital pharmacist at Moinhos de Vento Hospital, Rio Grande do Sul, Brazil.
United Arabs Emirates
Rabih Dabliz, PharmD: Dr. Dabliz is the Senior Manager for Quality & Medication Safety Services at Cleveland Clinic Abu Dhabi, UAE. He graduated with a Doctor of Pharmacy Degree from the Lebanese American University, Lebanon. He then completed his Post Graduate Pharmacy Practice Residency and Post Graduate Pediatric Pharmacy Residencies in the USA. Prior to joining Cleveland Clinic Abu Dhabi, Dr. Dabliz completed a Safe Medication Management Fellowship at the Institute for Safe Medication Practices (ISMP -USA). Dr. Dabliz’ main areas of interest are pediatric medication safety as well as the application of human factors and visual design in risk mitigation across the continuum of the medication use process.
European Medicines Agency (EMA)
Alexios Skarlatos: Mr. Skarlatos received a law degree from the Democretian University of Thrace in Greece and has a Masters in European Judicial Studies from the European Institute of Public Administration in Luxembourg. Mr. Skarlatos briefly worked for the Greek ministry of interior affairs in its EU & international department before moving to Luxembourg to work for the Translation Centre for the bodies of the EU as a legal linguistic expert. In 2001 he joined the EMA and in 2009 was appointed Head of the Product Information Quality section (now called Labeling Review & Standards Office). Mr. Skarlatos is responsible for all labelling aspects of centrally authorized products, namely review of product information, packaging materials (mock-ups & specimens), naming issues, coordination of translations in all EU languages, Chair of the Quality Review of Documents (QRD) group and Chair of the Name Review Group (NRG).
Geraldine Lissalde Bonnet: Ms. Bonnet is the director of the global office of an international non-for-profit standard development organization GS1. GS1 is known as the organization who created the retail barcode more than 40 years ago and develops global standards for unique identification and data sharing. She is the youngest director in the history of her organization. Prior to joining GS1, she worked in the private sector (law firms and public affairs departments), complemented by several years in the European Commission (dealing with gender equality and then with product safety). She is working with an increasing GS1 Healthcare Community, composed of large manufacturers, distributors and innovative hospitals, across 112 countries that achieve to bring to the same table policy makers and healthcare stakeholders to create together solutions that enhance patient safety and save lives around the world. She has recently grown the capacity for GS1 to be the common denominator for multiple international organizations (incl. WHO, UNICEF, Global Fund, GAVI, World Bank, USAID, APEC) working to scale up their humanitarian projects in Asia and Africa.
Greg Bylo: Mr. Bylo is the vice president of the GS1 US Healthcare sector, is an accomplished leader with over 25 years’ experience in supply chain, logistics, continuous improvement, ERP implementations, and operations management. He is responsible for working with industry stakeholders to understand their collective objectives and offer strategic guidance on the use of standards and technology to improve business and clinical processes in the healthcare sector. Prior to joining GS1 US, Mr. Bylo was the senior director of global supply chain support services at Integra Life Sciences where he was responsible for supply chain planning of global products. He also spent more than 15 years at Becton Dickinson leading supply chain business processes globally, sales and operations planning, and working across a multi-divisional structure to drive supply chain optimization focused on decreasing organizational supply chain costs and increasing customer engagement.
The Institute for Safe Medication Practices (ISMP-CANADA)
Michael J.A. Hamilton BSc, BEd, MD, MPH, CCFP: Dr. Hamilton is the Physician Lead and Medication Safety Specialist for ISMP Canada. Dr. Hamilton’s work at ISMP Canada is focused on the reduction of errors and preventable harm from the use of medications. Dr. Hamilton contributes to the investigation of medication errors, the development of mitigation strategies, and collaborates in the many ongoing research projects. He assists in representing ISMP Canada on many national and international organizations and has been privileged to be able to advise and educate health care providers, administrators, policymakers, and legislators about issues in medication safety. Dr. Hamilton also continues to work in general practice and long-term care.
The Brazilian Health Regulatory Agency (ANVIZA)
Douglas Simoes Costa Souto: Graduated in pharmacy and biochemistry with specialization in sanitary surveillance. Eleven years working at ANVISA, among them, 6 years dedicated to the registration of new medicines and therapeutic indications, 4 years carrying out inspections of good practices in the manufacture of medicines and health products and he currently occupies the position of coordinator of the area of registration of medicines of less complexity.