International Pharmacovigilance Day - Relatori

Martijn van de Leur has over 16 years of experience in pharmacovigilance.

Martijn van de Leur graduated from Radboud University as a Biomedical Scientist with specializations in Pathobiology and Oncology. Since 2005, he started to work in the life science industry, concentrating in the pharmacovigilance area. As a senior leader in pharmacovigilance and experienced (Deputy) EU QPPV, Martijn has a broad network within the industry and is a known industry speaker with excellent drug safety experience. Before joining Biomapas, he acted as Global Head of Drug Safety Compliance and Global Head of Drug Safety Technologies at Vifor Pharma, and further back in his career working as Pharmacovigilance Lead at Merck.

Martijn Dahlhaus is Head of Country Pharmacovigilance in The Netherlands at Bristol Myers Squibb. Heading the local pharmacovigilance organisation, he carries responsibility for all pharmacovigilance and risk management activities in The Netherlands and has regularly and successfully hosted PV audits. He is also deputy for Belgium and Luxembourg. Martijn has been in this role for the past 9 years, before which he held various roles in Pharmacovigilance and Medical Information at Genzyme and Novartis.  Martijn is an ACRP-certified CRA and holds a Master’s degree in Medical Biology and a PhD in Neurobiology, both from the Vrije Universiteit in Amsterdam, Netherlands.

Jørgen Matz, MSc, PhD, PgD is the Head of Global Pharmacovigilance & Drug Safety for InsudPharma in Madrid, which is a healthcare company with business units for worldwide manufacturing, development, and marketing of branded, generic and biotechnological products. Jorgen Matz has been in the pharmaceutical industry for about 25 years, hereof 15 years in Global Pharmacovigilance & Drug Safety. He has a background as an experimental pharmacologist and his focus areas in recent year has been on implementing pharmacovigilance systems tailored to support ICSR processing and continuous benefit-risk assessments of marketed products.

Dr Martin Huber is the German member of the Pharmacovigilance Risk Assessment Committee (PRAC) and has been a member of the Pharmacovigilance Working Party (PhVWP) before. He has been actively involved in many pharmacovigilance procedures including important referrals at PRAC and also contributes to the work of several working groups at the European level. Since October 2018 he is the vice-chair of the PRAC. In addition, he is also chairing the Non-prescription medicinal products Task Force of the CMDh since May 2017.
Being a pharmacist by training and holding a degree in public health he gathered comprehensive experience in pharmacovigilance in a hospital setting both in Germany and Switzerland before entering BfArM in 2010. Since 2013 he has been head of the unit ‘PRAC and other Committees’, and since 2017 he is head of the unit ‘PRAC, Legal Status, Adverse Reaction Reports, Medication Errors’ within BfArM’s division of pharmacovigilance.

Ranjana has a Masters in Technology and a Post Graduate DIploma in Pharmacovigilance. She has been working in this field since 2004, starting her career in Safety Case Processing in a CRO followed by working in various Pharmaceutical companies. Since 2012, Ranjana has been responsible for Pharmacovigilance Quality assurance which includes conducting all types of audits, leading HA Inspections, providing Training and overseeing all QMS aspects. She has led teams globally, presented at several conferences and published articles on aspects of Pharmacovigilance QA.

Ashraf Megahed holds a Bachelor of Science in Pharmaceutical Science from the University of Tanta Egypt, a Graduate Certificate clinical and Drug Development university of New South Wales Australia and a Graduate Certificate Clinical Pharmacy Queen’s University Belfast Ireland. With over 30 years’ experience in the pharmaceutical industry, in his last role, he worked in Aspen Healthcare as MENA Regional QPPV & Quality Manager to setup the local quality Management system and the local Pharmacovigilance system until his current role. Ashraf Megahed is currently the Regional QPPV for the Arab region markets and Iran.  He is responsible of establishing and maintaining/managing the company’s pharmacovigilance system in Arab Region. He maintains Local PSSF and oversight over all delegated tasks and the entire Local pharmacovigilance system.  Personally, responsible for the safety of the products marketed by Vifor Pharma so he has an overview of the safety profiles and any emerging safety concerns for the company’s products.

Nina Sagbana holds a Bachelor of Science in Pharmaceutical Science from the University of North London, the UK, and a master’s in Environmental Technology from Imperial College London, UK. She began her career in the pharmaceutical industry with GSK in 2002 as a clinical coding specialist in data management and transitioned to pharmacovigilance in 2004.

With over 17 years’ experience in the pharmaceutical industry, in the last 5 years, she worked in Roche as a consultant International PV Leader for EEMEA, at Syneos Health, as the Associate Director Safety & PV responsible for the setup of the local PV networks until her last role at Vifor Pharma. Nina Sagbana worked as the International Deputy QPPV at Vifor Pharma based in Zurich, Switzerland. She was responsible for the oversight of pharmacovigilance activities in the non-EU countries/regions, as well as PV regulatory intelligence within Vifor’s global PV organization. As part of her operational activities, she was also responsible for the maintenance of the Vifor Pharma Pharmacovigilance System Master File (PSMF) and provided guidance to Regional and local QPPVs on the creation of PV Sub-System Files (PSSF). She is currently an independent pharmacovigilance consultant.

Jose Torres Fuenzalida holds a Master of Sciences in Biology and a PhD in Biology from the National University of Buenos Aires, Argentina. He began his career as a basic science researcher in the Liver Stem Cells field. After 10 years in research, he decided to move to the pharmaceutical industry. He joined Cognizant Technologies Solutions as a Safety Data Analyst in 2011 and, in 2013, he was promoted to PV Team Leader. In 2015 he received the opportunity to join the National Health Authority in Argentina (A.N.M.A.T.) as Advanced Therapies Medicinal Products Leader and, in 2017, he was promoted to Chief of the Department of Biological Products in the same institution.

Jose Torres Fuenzalida is currently the Regional QPPV for Latin America (LATAM) Region at Vifor Pharma based in Buenos Aires, Argentina. He is responsible for the oversight of pharmacovigilance activities performed by the commercial partners in LATAM region. As part of his regular activities, he provides PV training and shares best practices with commercial partners.

Professor Bart van den Bemt is clinical pharmacist, clinical pharmacologist and senior clinical scientist at the departments of Pharmacy in the Sint Maartenskliniek and the Radboud University Medical Center in Nijmegen, The Netherlands. Bart is medical manager of the in- and outpatient pharmacy of the Sint Maartenskliniek and head of Research and Innovation of the same hospital.

Bart earned his MSc in pharmacy and his pharmacist’s degree at the University of Utrecht. Subsequently he completed his postgraduate qualification as community pharmacist. After several years working in a community pharmacy Bart decided to broaden his experience and started to work as pharmaceutical care-developer for a franchise formula for community pharmacies. Since 2003 Bart is working at the Sint Maartenskliniek.

Due to his experiences as community-, clinical-, outpatient- and formula-pharmacist Bart has extensive experience of pharmacy practice, the development pharmaceutical care programs and development of educational programs. Bart also founded a new Dutch bachelor course Pharmaceutical Consultant and is member of several committees/boards on pharmacotherapy, education, pharmaceutical care and outpatient pharmacy. Bart was president of the European Society of Clinical Pharmacy and vice-president of the Dutch Association of Hospital Pharmacy..

Bart’s research interests are focused on Personalized Pharmaceutical Care including medication adherence, e-health, medication review, therapeutic drug monitoring of biologicals, inflammatory pain, transitional care and medication wastage.

Olga Asimaki is a certified Medical Affairs professional experienced in Pharmacovigilance and Medical Information activities. After Olga decided to move to the pharmaceutical sector leaving Academia and Research, she started her career in Pharmacovigilance in Zencro, a European CRO, and later moved to large Pharma for over 7 years as Head of Pharmacovigilance and Medical Information at AbbVie. Olga has extensive experience in all aspects of Pharmacovigilance, leading and developing PV teams and local PV systems. Additionally, Olga has successfully led the PV function through audits and inspections and driven a plethora of global projects and initiatives. With regard to Medical Information, she worked with AbbVie’s global teams to successfully launch and implement a global Medical Information system and processes.

Currently, as International QPPV in Biomapas, Olga is leading the QPPV Office, and overseeing the global network of Regional QPPVs and the Full PV activities executed by Biomapas.

Olga is a post-doctoral Neuroscientist holding an MSc from King’s College London and a PhD in Pharmacology (BRFAA / School of Medicine, University of Thessaly). After joining the industry, Olga obtained an official certification from King’s College/IFAPP in Medicines Development.

Ruth López Magdaleno is the Clinical and Pharmacovigilance Quality Manager for Insud Pharma in Madrid, which is a healthcare company with business units for worldwide manufacturing, development, and marketing of branded, generic and biotechnological products. Ruth López Magdaleno works in Pharma Industry since 2001, majority of the time in Clinical Operation Departments changing into a Quality Department in 2015. She has a big experience implementing systems across the different business units and countries, leading and hosting GCP and GVP audits and inspections across de World.

Christel Gremion Viatte leads currently the Global Regulatory Affairs CTA group at CSL Behring. She has 16 years experience in management of global clinical trials and in development of clinical trials regulatory strategy. For the EU Clinical Trial Regulation EU536/2014 she was involved in early testing of the CTIS submission portal and contributed as sponsor representative to EMA stakeholder readiness activities. Since several years, she is actively involved in the workstream getting CSL Behring ready for this regulation.
Christel holds a PhD in Immunology and a Regulatory Affairs Certificate in Pharmaceuticals and Medical Devices from the RAPS University.

Livia Del Rey is responsible for supporting Patient Safety activities in Spain, including Risk Minimization programs, interaction with NCA on safety-related matter, ensuring overall audit/inspection readiness, regulatory compliance and assisting as deputy for the Head of Country Pharmacovigilance in collaboration, with the local business organization. She also worked on a temporal assignment in Middle East and Africa as Head of Country Pharmacovigilance for BMS, broadening her knowledge in other markets. Livia holds a bachelor degree in Pharmacy from Universidad de Alcalá de Henares, Spain. She started her professional career working in community pharmacy and later moved into the Pharmaceutical industry holding roles of greater responsibility in Medical Information and Pharmacovigilance for the last 14 years.

Željana Margan Koletić is Head of Department for Pharmacovigilance and Rational Pharmacotherapy at Croatian Agency for Medicinal Products and Medical Devices (HALMED) with more than 10 years of pharmacovigilance experience. She is pharmacist by training and holds a degree in clinical pharmacy. She is author of Croatian guidelines for the national approval of additional risk minimisation measures (aRMMs) and Dear Doctor Letters (DHPCs) published on HALMED’s website. Together with her team, she is responsible for coordination of SAFE-CT, an EC project for increasing expertize in EU national agencies for safety assessment in clinical trials following implementation of EU CTR. She is member of HALMED’s Medicinal Products’ Safety Committee and since 2016 she is Croatian Alternate Member of Pharmacovigilance Risk Assessment Committee (PRAC).