International Pharmacovigilance Days

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.

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.

Education
Pharmacist, Bachelor of Pharmacy – Ain Shams University- Cairo – Egypt (2007)
Post graduate studies in epidemiology, Pharmacovigilance, Biostatistics, Drug Adverse reactions and Pharmacotherapy, Cairo University (2018)

Work Experience:
Working for Kyowa Kirin International as Pharmacovigilance Manager, Middle East & LSO UAE, Oman, Kuwait and Qatar (June 2020 – current)
worked for Vifor Pharma-International as Regional QPPV, MENA / LSO UAE and Quality Manager GCC (August 2018 to June 2020)
Worked for Minapharm Pharmaceuticals-Egypt and Rhein-Minapharm as QPPV/ Pharmacovigilance Manager (May 2016 to July 2018)
Worked for Hochster Pharmaceutical Industries-Egypt as QPPV (Dec. 2014 to April 2016)
Worked for Ministry of Health- Egypt as Quality GMP, GDP,GVP,GLP (GxP) Auditor and Inspector (Nov. 2008 to Nov. 2014) , audited and inspected around 70 Pharmaceutical Companies in the region in addition to auditing the only oncology Pharmaceutical factory in the Arab region.
Scientific training and experience
PV Speaker and Trainer in different international conferences
Has various trainings in the fields of Pharmacovigilance in addition to Pharmaceutical Quality and Auditing, as well as on job continuous training, below are the major trainings:
Pharmacovigilance Training GCC (2019, 2020 & 2021)

John Barber is the Managing Director and Lead Consultant for Plain Pharma Consulting. Until May 2019, he was the EEA QPPV and Head of Pharmacovigilance and Commercial Quality for Dr. Reddy’s Europe. Prior to that, he was Global Clinical Pharmacovigilance Manager for Glenmark Pharmaceuticals, during which he initiated the development of the company’s Pharmacovigilance quality management system for its clinical development programme. He was previously employed by Alliance Pharmaceuticals, a specialist UK pharmaceutical company, where he was latterly Director of Scientific Affairs. In this role, he was responsible for pharmacovigilance, medical information and clinical development. He also has experience as an information analyst with ICI Pharmaceuticals, Roche and Glaxo Wellcome. He is a Past President of the UK Pharmaceutical Information and Pharmacovigilance Association (PIPA) and has been a lead on pharmacovigilance issues for the British Generics Manufacturers Association (BGMA) and the European Generics Association (now Medicines for Europe). By education, he is a pharmacologist, attaining a BSc (Hons) from the University of Liverpool.

Andras Berta is CEO and Principal Consultant of the Swiss specialty management consultancy StratoServ Sciences AG founded in 2019 to offer services to the pharmaceutical sector in relation to R&D, Patient Safety, IT, Strategy and related Cloud Services. From Oct 2019 to end of 2020 via StratoServ Sciences Andras has been acting as the Chief Strategy Officer of ArisGlobal where he has been instrumental in unifying the Product Strategy Organization to include all domains (PV, Regulatory, Clinical, Medical, Quality, Strategy and Design) and has led the definition of a mid and long-term functional and non-functionality related Product and Platform Strategy.

Andras is a Medical Doctor and holds a Masters Degree in Healthcare Management, as well as an MBA. Andras started his pharmaceutical career at Gedeon Richter where he held ascending roles to Deputy EU QPPV and Deputy Global Head of Pharmacovigilance and lead Gedeon Richter’s initial 5.1.x ARISg implementation and the restructuring of their Global PV system and procedures. In 2010, Andras joined the Vifor Pharma as Global Head Drug Safety Operations. In 2013, Andras was promoted to VP, Global Drug Safety and Risk Management at Vifor and worked closely with ArisGlobal to partner on their next-generation Safety system, LifeSphere MultiVigilance. Andras has been instrumental in implementing EU Good Vigilance Practices and relevant Swiss and US FDA regulations and conducting fast-track full PV integrations of Switzerland-based OM Pharma and US-based Relypsa companies following their acquisitions.

Between 2011 and 2016 Andras has been member of the PV Committee of European Federation of Pharmaceutical Industries and Associations (EFPIA), and between 2018 and 2020 member of the ArisGlobal Safety Advisory Board.

During his career Andras has been overseeing 14 statutory PV inspection (including MHRA, EMA, Swissmedic, FDA and TGA).

Mihai Alexandru Bica is a Director, Clinical Safety Physician at CSL Behring in Marburg, Germany, Fellow of the Royal Society of Public Health in London, United Kingdom and Fellow of the Academy of Science in Siena, Italy. He obtained his medical degree at the University of Medicine Iasi, Romania in 2006 and specialised in infectious diseases epidemiology in 2012; He completed his MPH studying Health Management, Bioinformatics and Biostatistics and has an executive Master degree in Vaccinology and Pharmaceutical Clinical Development from the University of Medicine Siena, Italy where he graduated “cum laude” in 2016. He is currently overseeing the active monitoring and continued assessment of safety profiles of a wide range of therapeutics and conducts multiple clinical research activities in therapeutic areas such as Immunology, Infectious Diseases, Respiratory and Transplant. Previously he lead clinical and pharmaco-epidemiological research activities with prophylactic mRNA-based and recombinant vaccines focusing on rabies, influenza, meningitis, shigella and various oncological indications at GSK and CureVac AG. Prior to this he served as Head of the Epidemiology and Disease Control Department at the National Public Health Authority of Romania within the Ministry of Health where he coordinated several national programs for immunizations, infectious disease control and epidemic and pandemic preparedness. He has successfully interacted with international groups interested in clinical and epidemiological research as also public health issues regarding migrant health. These include the World Health Organization (WHO) or the European Centre for Disease Prevention and Control (ECDC). His publication includes several manuscripts on various topics in public health, infectious diseases, epidemiology and rare diseases

Antonella Cardone is the Director of the European Cancer Patient Coalition, which is the largest cancer patient umbrella organization in Europe with over 450 members from 49 countries. She has over twenty years of international activity in health, social and employment sectors. Prior to ECPC, Antonella was the Executive Director of the Fit for Work Global Alliance, a multi-stakeholder coalition championing change in health and work policy. She was previously Director of the Global Smokefree Partnership of the American Cancer Society, leading a movement of over 100 members to coordinate the development of smokefree laws in 40 countries. She holds a Master’s in Science and one in Business Administration. She currently represents ECPC on the Board of Pancreatic Cancer Europe.

Education: Pharmacist (Pharm D) & MBA in Health Management
Background: Regulatory affairs, Pharmacovigilance and Quality Assurance
Location: Chicago, IL

Abbvie Background Information:
2015: AbbVie employee for 6 years joined as Affiliate Safety Representative for Levant and Pakistan
2017: Worked on Merger with NWA and was nominated PV Hub Lead for Near East North West Africa
2018: Joined the Affiliate Vigilence Excellence for CEE region
2019 to Present: International Pharmacovigilance Operational Excellence & EEMEA Pharmacovigilance Point of Contact.
Current Focus & Project:
• Global Affiliate PV system oversight integration strategy Lead
• Pharmacovigilance Hub Integration Lead
• Affiliates COVID-19 IPEx Link: Development of global guidance and Affiliates Contingency Plan
• Global Biosimilar Readiness Strategy Lead for Affiliates
• Affiliate Learning & Development Program Lead including: National QPPV Framework, Affiliate Medical Director, Affiliate Safety Representative Pharmacovigilance Onboarding and Continuous Learning.
• Development and Global Roll-out of Affiliate Safety Representative Success Profile and Talent Development Strategy and Process (including stakeholders’ engagement and Communication Plan)

François Houÿez is working at the European Organisation for Rare Diseases EURORDIS where he is Director of Treatment Information and Access.
He has always been working as a patient advocate since the early 90s, first in the HIV/AIDS advocacy, and in rare diseases since 2003.
He represents EURORDIS at the Patients’ and Consumers’ Working Party at the European Medicines Agency (EMA). François advised the SCOPE joint Action on pharmacovigilance, took part in the development of a mobile app to report suspected adverse drug reactions.
François is also a patient.

Kristina Keeler is currently the Senior Director of Global Safety Operations at Drug Safety Navigator, based in Research Triangle Park (RTP), North Carolina.  She has more than 13 years of experience in the healthcare and pharmaceutical industry. Prior to joining DSN four years ago, Kristina held vital roles at (Ashfield, Quintiles, WRB), where she developed deep expertise in Post-Marketing, managing Medical Information programs, building Medical Information and PV departments, Post-Marketing pharmacovigilance requirements and management of vendors, budgets and PV programs.

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.

Claudia Lehmann serves as Vice President of Global Patient Safety & Pharmacovigilance Operations & Systems for Boehringer Ingelheim.

In her current role she has oversight for PV operations including PV system implementation and governance, case management, GPV writing, PV agreements with license partners, internal and external compliance and GPV vendor oversight and governance including oversight and a digital innovation lead.

Claudia has designed many core processes in her area of accountability and with colleagues in teams across other functions in medicine, has implemented multiple systems and with them new technologies within BI medicine, such as remote data capture and most recently an end-to-end automation system for PV. She has also conducted interface training across the globe. In addition, she has always ensured a large internal and external network, being involved in external expert organizations such as the ICH MedDRA Management Committee, the Eudravigilance Expert Working Group headed by EMA, and in prior years the CDISC consortium.

Claudia has been trained in medical information management at an affiliation of the University of Ulm, Germany.

Lidia Maksyutkina is a Regional Pharmacovigilance Manager, Russia and CIS at Biomapas. Prior to working in pharmacovigilance, Lidia Maksyutkina has graduated Chuvash State University, faculty of medicine, qualified as a Medical Doctor. She worked in Russian Academy of Medical Science, Research Center of Neurology as a neurologist for 7 years. Lidia holds a PhD degree in medicine with a specialty in neurology. Lidia began working in Pharmacovigilance 8 years ago. She started as a PV specialist and then led the PV team in Russia ana CIS countries. She is experienced in PV system management, local PSMF maintenance, patient support, real world evidence programmes and other diverse projects.

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.

Laimonas Sutkus is an IT infrastructure specialist with over 7 years of experience in software development, cloud architecture, and IT team coordination. Laimonas has mostly worked on cloud-based and artificial-intelligence-based projects with FinTech companies and startups. His career has begun as a Software Developer in Bentley but quickly rose to a Lead Developer to a Team Lead to a Chief Technology Officer in iDenfy. In early 2020 Laimonas has joined Biomapas as a Chief Technology Officer to lead a growing IT department and implement cutting-edge automation solutions. Biomapas is a functional and full outsourcing solution provider to the global life science industry.

Gianluca Trifirò is MD, with post-graduate degree in Clinical Pharmacology (University of Messina, Italy), Master of Science in Clinical Epidemiology (NIHES, NL) and PhD in Clinical Pharmacology (University of Messina) and Pharmacoepidemiology (Erasmus Medical Center, Rotterdam, NL). He currently works as Full Professor of Pharmacology at the University of Verona and with honorary position at the Department of Medical informatics of the Erasmus Medical Center of Rotterdam. He is member of the Scientific Secretariat of postmarketing surveillanve Office of the Italian Drug Agency and clinical pharmacologist of Phase I Clinical Trial Unit of Bambino Gesù Pediatric Hospital of Rome (Italy).

He is scientific coordinator of an Academic Master program on “Use of Real world data for evaluations in Pharmacovigilance, Pharmacoepidemiology and Pharmacoeconomics” at University of Verona and he is the scientific coordinator of the Italian Society of Pharmacology working group on pharmacovigilance, pharmacoepidemiology, pharmacoeconomics and & Real World Evidence.

He has been active in the field of pharmacovigilance and pharmacoepidemiology since around 20 years. He is member of the steering group of the International Society of Pharmacovigilance and of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) of European Medicine Agency and member of advisory board of International Society of Pharmacovigilance.

He is member of Editorial Boards of Drug Safety, Pharmacoepidemiology and Drug Safety, Biodrugs, and Clinical Drug Investigation.

Authors of more than 200 publications on international scientific peer-reviewed journal.

Willemijn has worked in the pharma industry for >20 years, both in Clinical Research and Safety functions.
She joined BMS in 2003 in the World Wide Patient Safety organisation and is currently responsible for Patient Safety in the European Region. She has extensive experience with the development and management of the PSMF. Willemijn is the chair of EFPIA IPVG.

Dr J Vijay Venkatraman is a Diabetologist, Drug Safety Physician and Entrepreneur, with 16 years of experience. He holds a MBA degree in Services Management. He is the first Indian to have been conferred the Fellowship of the Pharmaceutical Information & Pharmacovigilance Association (PIPA), UK.
Dr Vijay founded Oviya MedSafe, a global Pharmacovigilance Consulting & Drug Safety Services company incorporated in Coimbatore, India and London, UK, which has been fulfilling the compliance needs of the global pharmaceutical industry since 2012.
Dr Vijay holds the honorary position ‘Regional Editor, India’ of Global Forum, the official magazine of the Drug Information Association (DIA). He has been the Chair of the Pharmacovigilance Council of the Indian Society for Clinical Research (ISCR), since the inception of the council in 2015.
Dr Vijay is an invited speaker and chairperson in national and international conferences. He has numerous publications to his credit. He is a member of several professional associations and is actively involved in promoting pharmacovigilance awareness among all stakeholders of the discipline.
Dr Vijay is a recipient of many awards including the ‘Leadership Excellence Award’ and the ‘State Appreciation Award for Co-ordinating Academic Activities’ by the Indian Medical Association.

Richard Wolf is the Executive Director, Pv Operations Head in the Global Clinical Safety and Pharmacovigilance group at CSL Behring. He directs Case Management, Medical Evaluation, Manufacturing Site Pharmacovigilance Representatives, Combination Products Pv Center of Excellence, and Pv Business Process and Technology groups.
Richard has been with CSL for the past 6 years, having spent the prior 12 years working across many areas in Global Medical Safety at Johnson and Johnson.
He earned a BA from the University of Richmond and an MBA from Rutgers Graduate School of Management. Richard was also an Accenture manager and an Airborne Ranger qualified Infantry officer in his life prior to joining the pharma industry.