Leadership in Patient Safety Journey: Active Pharmacovigilance & Pharmacoepidemiology

Head of Regulatory Affairs Boehringer Ingelheim Hellas Single Member SA

Grigoris Agyralidis is a Pharmacist with a Master’s Degree in Industrial Pharmacy (Department of Pharmacy, University of Athens). He has almost 20 years of working experience in the Pharmaceutical Industry mainly focused in the fields of Regulatory Affairs and Pharmacovigilance. He has authored scientific and business articles and given many lectures in Greece, Cyprus and abroad. His current business position is Head of Regulatory Affairs in Boehringer Ingelheim Hellas with responsibilities for Greece and Cyprus. He is also an active member of the Regulatory Affairs working group of the local Pharmaceutical Industry Association (SFEE) and coordinator for Regulatory Science topics of ELEFI.

Board Member, Greek Patients Association 

Dimitrios Athanasiou holds a BA in Business Administration and an MBA in Financial Management. He speaks three European languages and has more than 25 years’ experience with international business projects, working in various countries in consulting, developing and reorganizing companies.  

When his son was diagnosed with Duchenne Muscular Dystrophy, a fatal and incurable rare disease, he become a strong international patient advocate in Duchenne and Rare Diseases.  

Having a passionate personality and technocratic background, he educated himself with basic rare disease and advocacy knowledge via the EURORDIS Summer School and then with the 14 month Patient Expert Course of the European Patient Academy of Therapeutic Innovation (EUPATI) acquiring basic biotech and regulatory knowledge, where he served as a Member of EUPATI’s Course Committee for the next year, representing the patient voice. Being a EUPATI fellow, he established the Greek EUPATI National Liaison Team.  

Locally in Greece he is the patient representative of MDA HELLAS, created an active network of patient advocates, and became a board member of the World Duchenne Organization (WDO) promoting a vibrant network of patient organizations where children with DMD will have access to the best care irrelevant to where they live. He is currently also a board member in European Patient Forum EPF, the umbrella of the patient organizations in Europe. He serves in the Board of Greek Patients Association and is a member of 95 Rare Alliance Greece.  

In his role as a patient advocate, he interacts with Regulators, HTA authorities, Industry and Academia promoting the rights of patients with rare diseases to have access to the best care possible and to new, safe and affordable drugs for rare diseases.  

As a strong and committed patient advocate for DMD and rare diseases, he serves the patient community through various roles. He is a board member of EPF, a EURORDIS EPAC/TAG member, he served in the Board of the European Forum for Good Clinical Practice (EFGCP), Co-Chairing the Children Medicines Working Party (CMWP), Patient Advisor in TREAT-NMD Advisory Committee for Therapeutics (TACT), DIA’s Program Committee Member and many others.  

In 2014 he was nominated patient expert by EMA for DMD and has participated in several of EMA’s Scientific Advice, SAG, Protocol Assistance and CHMP pilot meetings for Duchenne, providing the essential patient representative perspective when companies request regulatory advice or approval.  

He currently serves as PDCO member in European Medicines Agency representing EURORDIS since 2017.

Independent Medical Consultant Internal Medicine, Pharmaceutical Medicine Consultant, Research & Experimental Development Consultant

EL.E.F.I. President and IFAPP President-elect

Dr Baroutsou is a Licensed Physician certified in Internal Medicine.

She studied in Greece, Sweden and France, worked as a Hospital Physician & Clinical Investigator in Greece and as Pharmaceutical Physician in Clinical Development and Medical Affairs in Pharmaceutical Industry leadership roles in Greece, France and Switzerland with her latest position being Western Europe Chief Scientific Officer at Novartis. She has a wealth of experience in medicines development with a contribution to more than 200 global clinical development programmes that led to the successful introduction of innovative drugs and publications for the clinical practise of Medicine. 

Currently an Independent Medical Consultant and Pharmaceutical Medicine Consultant, affiliated with Greek Medical Schools’ postgraduate courses on Infectious Diseases, Molecular Basis of Human Diseases, Clinical Pharmacology Therapeutics and Current Challenges in Public Health.

Barbara is the President of Hellenic Society of Pharmaceutical Medicine and IFAPP President Elect.

Moreover, she is a member of EFGCP core Faculty, ACG Deree Graduate School Professional Studies in Pharmaceutical Medicine, a Stavros Niarchos Foundation Bioethics Academy Alumni and Editor-Reviewer of Greek and International Journals -including Frontiers in Pharmacology, Drug Outcomes Research &Policies.

Patient Safety Specialist, Patient Safety Department, Global Drug Development, Novartis

Eirini Chatzopoulou started her professional career in 2010 at Novartis Hellas as a medical representative in Pharma, then moved to the medical department as a Clinical Research Associate at Trial Monitoring Organization and in the last years she has assumed the role of Patient Safety Specialist in the Patient Safety Department/Global Drug Development. She currently has undertaken a short-term assignment in Development Quality in Novartis Spain. She holds a degree in Biology from the National and Kapodistrian University of Athens, a Diploma in Sales Management from EEDE (Hellenic Society of Business Administration) and a Medical Affairs in Medicines Development Certification Program by IFAPP Academy & London Kings College.

Medical Inf. & Patient Safety Manager, Country DPO Deputy

Georgios has worked in pharmaceutical sector since 2006 in various positions. Starting as a Clinical Research Associate (PhIIIb-IV) at Sanofi Greece for 5 months, Regulatory Affairs Officer for 10 years (also being a Pharmacovigilance (& Product Technical Complaints Handling) Back-up for some years), and as Drug Safety Unit Lead for Greece & Cyprus for 1½ year. In 2017, he joined AstraZeneca Greece as Medical Information & Patient Safety Manager, and since August 2018 he has the roles of Medical Information & Patient Safety Manager and AstraZeneca’s DPO’s local representative in Greece. He holds a BSc (Hons) in Biomedical Sciences from Northumbria University (UK) and a MSc (Med Sci) in Medical Genetics from University of Glasgow (UK).

President, Greek Patients Association 

Nikos Dedes is founder and chair of ‘Positive Voice’, the Greek Association of People Living with HIV and Chair of the Greek Patient Organisation.  

Nikos has a longstanding involvement in European organisations and initiative and is currently member of the Steering Committee of NEAT id (European Treatment network of HIV, Hepatitis and Global Infectious Diseases), member of the HIV Treatment Guidelines Panel of EACS (European AIDS Clinical Society) and a member of the Steering Committee of the “HIV Outcomes” and “EuroTEST” initiatives.  

Nikos has been past chair of the European AIDS Treatment Group (EATG), past member of the Management Board of the European Medicines Agency (EMA) and past member of the WHO Strategic and Technical Advisory Committee on HIV. Nikos advocates for universal access to evidence-based and cost-effective care and prevention services for all people as a moral imperative and pre-condition for a prosperous and fair society.

Pharmacovigilance Manager  “Pharmassist Ltd”

Alexandra Falara has a bachelor in Nursing (2009) and a Master in Health Management (2011), both from the University of Athens. She has been working in the pharmaceutical business and specifically in Pharmacovigilance sector since 2012. Currently, she holds the role of the Pharmacovigilance Manager in the Contract Research Organisation “Pharmassist Ltd”.

During her career, she has had the opportunity to work for many Major Pharmaceutical companies, providing support in both national and international level, while she has occasionally engaged in various big projects such as RMP and aggregate reports writing (for both generic and innovator medicinal products), participating in audits/ inspections and performing signal detection.

From her current position as Pharmacovigilance Manager, she is leading those groups of professionals working in pharmacovigilance department on signal detection and aggregate reports development – whose activities cover a broad range of drug classes.

In terms of professional training, she has participated in several trainings and events, such as the training on electronic reporting of ICSRs organized by DIA Global, for which she is officially certified. During her 10-year experience she has gained solid knowledge in the whole range of pharmacovigilance processes – from ICSRs data entry and analysis, authorship of medical safety documents, to development and implementation of standard operating procedures and corrective plans.

Biologist (PhD), Cell Therapy Medical Manager, Novartis Greece

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Associate Medical Director Greece, Cyprus & Malta, Novartis Gene Therapies Switzerland

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Assoc. Prof of Hygiene and Environmental Protection, Medical School of Alexandroupolis, Democritus University

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Consultant in Respiratory and Critical Care Medicine, ex Director of the Critical Care Unit of Konstantopoulio Hospital ‘Agia Olga’ Athens ,Greece

Dr Nina Maguina-Vlachantoni is a consultant in Respiratory and Critical Care Medicine with a special interest in Medical Education, Clinical Quality Assessment and Bioethics.

She graduated from Pierce College (1970) and obtained her medical degree from the University of Athens in 1976. After completing her Respiratory Medicine specialty training in Athens in 1981, she went on to subspecialize in Critical Care Medicine at the Cedars Sinai Medical Center UCLA in Los Angeles. She subsequently obtained significant clinical experience as a consultant at the Center for Respiratory Failure at the Athens Chest Hospital ‘Sotiria’ until 1991 before being appointed to found and establish the Critical Care Unit of Konstantopoulio Hospital ‘Agia Olga’ which she continued to manage until her retirement in 2015.  Her PhD focused on ICU patient mortality prediction based on severity scores on admission.

As head of the Critical Care Unit, Dr Maguina-Vlachantoni organized and coordinated specialty training for medical trainees as well as nursing staff with an emphasis on Rescuscitation training as a certified BLS/AED, ALS and ACLS instructor. Her main focus has been the standardization of critical care procedures and improvement of patient safety which led to a successful ISO accreditation of her ICU in 2008, the first of its kind in Greece.

Dr. Maguina-Vlachantoni was appointed in 1996 as the Editor-in-Chief of PNEUMON, the official Hellenic Society of Respiratory Medicine journal and held this position until 2006. During the course of her career Dr Maguina-Vlachantoni developed a keen interest in the connection between ethics and health that inform and affect the decision-making process within the Critical Care multidisciplinary team. She now focuses on teaching Quality and Performance improvement of Critical Care, Patient Safety and Bioethics in the clinical as well as in the academic post-graduate setting (University of Crete).

Patient Safety Specialist, Deputy of Patient Safety Head, Global Drug Development, Novartis

Adamantia Maniatakou is a graduate of the Department of Chemistry of the Aristotle University of Thessaloniki and holds a PhD from the Department of Chemistry of the National and Kapodistrian University of Athens.

She has worked as a medical representative in various therapeutic areas for 8 years at Novartis.

Since 2016 she has been working in the Patient Safety department of Novartis and since 2018 she has been a member of the Pharmacovigilance Working Group of EL.EFI.

Her current position is Patient Safety Specialist / Deputy of Patient Safety Head.

Physicist, MSc in “Medical Electronics and Physics, Head Pharmacovigilance at Creative Pharma & HR Services

Errietta Economou is a Physicist, graduate of the National and Kapodistrian University of Athens. She holds a master’s degree in “Medical Electronics and Physics” from St. Bartholomew’s Hospital, University of London.  From 1994 to 2001 she has been operating in the promotion and technical support of medical devices. She was in MSD (formerly Schering Plough), since 2001, in the fields of Clinical Trials, Medical Information, Quality Complaint Management and Pharmacovigilance. Since 2008 she has been the Head of Pharmacovigilance Department at CRO. Since 2016 she holds the position of Head Pharmacovigilance at Creative Pharma & HR Services.

Pharmacovigilance Manager, Menarini Hellas

Alexandra Patrinelli has studied Biology at Aristotle University of Thessaloniki and she has performed a PhD thesis in Toxicology at University of Surrey, UK in cooperation with the National Center of Scientific Research “Demokritos” in Athens.
She worked as a Post-Doctoral Research Fellow in Dept. of Chemical Pathology and Human Metabolism, The Royal Free Hospital, in London.

Between 1996 and 2019 she worked as a Μanager at the Pharmaceutical Company Pfizer Hellas in the functions of Regulatory Affairs, Pharmacovigilance, Scientific & Skills training.

Since October 2019 she has been working in the Pharmaceutical Company Menarini Hellas as a Pharmacovigilance Manager.

MSc in Clinical Pharmacy, Director of Pfizer’s Pharmacovigilance Departments for Southeastern Europe Cluster

Maria Polydorou is a pharmacist, a graduate of the National and Kapodistrian University of Athens (NKUA). She holds a master’s degree in Clinical Pharmacy from the same University (NKUA). Since 1999 she has been active in Pfizer Hellas successively in the fields of Regulatory Affairs, Medical Information and Pharmacovigilance. In 2006, she became the Lead of the Pharmacovigilance Department for Greece, Cyprus and Malta. Since 2010, she has been the Director of Pfizer’s Pharmacovigilance Departments for Southeastern Europe (Cluster Safety Lead for SEEU).

Vice President, K.E.F.I Association of Athens

Elisavet Psilopoulou is a graduate of the Economics University of Athens, having worked primarily in multinational enterprise-level companies throughout the years acting as the Chief Financial Officer. She has attended a variety of workshops, seminars and lectures mostly on topics surrounding finance and economics, strategic development as well as human resources.

In the year 2009 and after receiving a medical diagnosis of breast cancer, she was fortunate to have been given the unconditional psychological and emotional support that was needed through the K.E.F.I Association of Athens. As a sign of gratitude for all the help that she had received, she had made the decision to give back to the community by actively participating and contributing to the assosiation’s initiatives and activities.

As of the year 2010 she has been elected as a member of the Management Board in the function of the Treasurer, while in the latest elections she was appointed the position of the board’s Vice President. Throughout the years she has had the opportunity to act as the representative on behalf of the association in multiple events both in Greece as well as abroad.

BSc in Biology, MBA in Health Management, Pharmacovigilance& Regulatory Manager, Medical Department 

Eleonora Sarikou is a Biologist, a graduate of the Aristotle University of Thessaloniki. She holds a master’s degree in Health Management (Hellenic Open University of Patra). Since 1996 she has worked in GlaxoSmithKline, holding different positions in Sales, Clinical Operations, Pharmacovigilance and Regulatory Affairs departments. 

From 2014-2022 she was the Lead of the Pharmacovigilance Department in Greece, participating as a member of the Pharmacovigilance team of ELEFI. 

Since September 2022 she is the Local Delivery Lead in Clinical Operations for Greece. 

Since 2014 she is the Lead of the Pharmacovigilance Department in Greece. She participates as a coordinator in the Pharmacovigilance sub-group of SFEE and is a member of the Pharmacovigilance team of ELEFI.

PhD Biochemistry/Protein Engineering, BSc Genetics/Microbiology, Medical Affairs Manager Excelya

PhD graduate in Biochemistry/Protein Engineering from Imperial College London, BSc in Genetics/Microbiology from Queen Mary College (University of London) and Postgraduate Diploma in Cellular Therapies from Université Paris Diderot 7.

She has been working in Excelya Greece (formerly Zeincro) since 2014 in PV&Safety Department and since 2017 in Medical Affairs as a medical writer (current position Manager, Medical Affairs).

She has been teaching in the following MSc programmes:

• Regulatory Affairs (University of Nicosia, Cyprus) since 2019 and
• MSc Clinical Trials (University of Athens Medical School) since 2017

Health Economist, Visiting Research Fellow, University of York, UK, Founding Partner PharmEcons

Eugena Stamuli is a Health Economist (MSc, University of Sheffield, UK) with first degree in Pharmacy (BSc, National University of Athens, Greece). Her areas of expertise include cost-effectiveness modelling/early modelling for health technology assessment, design and conduct of economic evaluations alongside clinical trials, discrete choice experiments (DCEs), patient reported outcomes (PROs), utility elicitation and evidence review & synthesis. She has conducted numerous primary studies and analyses in various disease areas. Eugena is co-founder of PharmEcons Easy Access, an international consulting company in Health Economics, Outcomes Research and Market Access. She holds a Visiting Research Fellowship position with University of York, UK where she worked for nearly 10 years as an academic researcher.

Professor of Pharmacology and Internal Medicine
Director of Molecular Immunopharmacology and Drug Discovery, Department of Immunology, Tufts University School of Medicine, Boston, MA, USA

Dr. Theoharides was born in Thessaloniki, Greece, and graduated with Honors from Anatolia College. He received all his degrees from Yale University (BA, cum laude in Biology and History of Medicine, MS, MPhil, PhD, MD), and was awarded the Dean’s Research Award and the Winternitz Price in Pathology. He trained in internal medicine at New England Medical Center, which awarded him the Oliver Smith Award “recognizing excellence, compassion and service.” He also received a Certificate in Global Leadership from the Tufts Fletcher School of Law and Diplomacy and a Fellowship at the Harvard Kennedy School of Government.

He has been serving as the Clinical Pharmacologist of the Massachusetts Drug Formulary Commission continuously since 1986. In Greece, he served on the Supreme Advisory Health Councils of the Ministries of Health and of Social Welfare, as well as on the Board of Directors of the Institute of Pharmaceutical Research and Technology. He Chaired an International Committee appointed by the Hellenic Ministries of Education and Health for the establishment of an independent medical school in Greece, and he is a member of the International Advisory Committee for the University of Cyprus School of Medicine. He is also the Director of Health Science Programs and Research for the American College of Greece. He is a member of 15 academies and scientific societies. He was inducted into the Alpha Omega Alpha National Medical Honor Society and the Rare Diseases Hall of Fame.  He has received the Tufts Excellence in Teaching ten times, the Tufts Distinguished Faculty Recognition Award twice, the Tufts Alumni Award for Faculty Excellence, and the Dr. George Papanicolaou Award. He has also been awarded an Honorary Doctor of Medicine from Athens University and an Honorary Doctor of Sciences from Hellenic-American University, as well as the 2018 Albert Nelson Marquis Lifetime Achievement Award.  

Dr. Theoharides is a member of the American Academy of Allergy, Asthma and Immunology. In 2020, he was inducted in the World Academy of Sciences. For his humanitarian efforts, he honored with Boston Mayor’s Community Award, the 2018 Distinguished Humanitarian Award (Marquis Who is Who), and he was recognized as “Archon” of the Ecumenical Patriarchate of Constantinople. Dr. Theoharides first showed that mast cells, known for causing allergic reactions, are critical for inflammation, especially in the brain, and are involved in a number of conditions that worsen with stress such as allergies, asthma, autism spectrum disorder, eczema, fibromyalgia, interstitial cystitis/bladder pain syndrome, mast cell activation syndrome, migraines, multiple sclerosis, myalgic encephalomyelitis/ chronic fatigue syndrome, psoriasis and Long-COVID syndrome. He has published over 470 scientific papers (JBC, JACI, JPET, NEJM, Nature, PNAS, Science) with 465 papers in Pubmed.gov; 40,984 citations; h-index 97) and 3 textbooks. He has been placed in the world’s top 2% of most cited authors and the top-rated expert in the world on mast cells by Expertscape. Dr. Theoharides is also the Scientific Director of Algonot, LLC (Sarasota, FL) and has helped formulate unique dietary supplements (e.g. ArthroSoft^®, BrainGain^®, CystoProtek^®, FibroProtek^®, NeuroProtek^®, PureLut^®) and a skin lotion (GentleDerm^®) containing the novel anti-inflammatory flavonoids, luteolin and tetramethoxyluteolin. He has received 37 patents and trademarks, including some covering the use of luteolin in brain inflammation and autism: US 8,268,365 (09/18/12); US 9,050,275 (06/09/15); US 9,176,146 (11/03/15). Web: www.mastcellmaster.com

Safety Value Partner, Roche (Hellas) S.A.

Christina Tsougkou was born in Athens. He studied Pharmacy at the University of Bari, Italy. She has worked in pharmaceutical companies in the field of Sales & Marketing, in the Medical Department as Head of Clinical Studies and in the Quality Department as Head of Product Quality Assurance. Since 2007, she has been working as a Pharmacovigilance Manager, while since 2019 she has been a Pharmacovigilance company at Roche Hellas.

She actively participates in the Pharmacovigilance sub-group of SFEE and is a member of ELEFI.

PhD Candidate, Health Technology Assessment, Health Policy Dept, University of West Attika

Konstantinos Zisis is a health economist and policy analyst by training. He studied Health Management & Health Policy and Planning. Currently, he is PhD candidate in health technology assessment (HTA) at the Department of Public Health Policy, School of Public Health, University of West Attica, investigating the role and feasibility of real-world data (RWD) for HTA process.

He has many years of experience in the private health sector (health services), as well as in research institutions in regards to health policy and economics, while he has also collaborated with governmental agencies in public health (ECDC) and education (Hellenic Authority for Higher Education). Today, he is working as Country Approval Associate at Pharmaceutical Product Development (PPD), Part of Thermo Fisher Scientific.

Konstantinos focuses his research in the fields of economic evaluation in healthcare, evidence-based healthcare and HTA having published several papers and abstracts in health policy and economics, and is regular reviewer for international journals such as Value in Health and International Journal of Technology Assessment in Health Care. He is a member of Hellenic Society for Health Economics and Policy.