Governance

Dr Baroutsou (MD, PhD, EMAUD¹, GFMD²⁾ is a licenced Physician certified in Internal Medicine. She studied in Greece, Sweden and France and worked as a Hospital Physician and Clinical Investigator in Greece and as a 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. Dr Baroutsou 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 practice of medicine.

Currently, Dr Baroutsou is an Independent Medical Consultant and Pharmaceutical Medicine Consultant, affiliated with the Greek Medical Schools’ postgraduate courses in Infectious Diseases, Molecular Basis of Human Diseases and Clinical Pharmacology Therapeutics. Simultaneously, Dr Baroutsou is the President of the Hellenic Society of Pharmaceutical Medicine, active with CME³ activities in collaboration with Biomedical Research Institutions and Medical Scientific Societies.

Moreover, Dr Baroutsou is a member of the EFGCP⁴ Core Faculty and an active Member of the IFAPP Ethics, External Affairs and Communication Working Groups. Her major inspiration lies in collaborating with academia, pharmaceutical medicine experts, clinical investigators, patient associations and regulators putting the patient at the centre of Research and Development and innovation in the healthcare agenda.

Dr Baroutsou is a purpose-driven leader, passionate about science, research and people. She is a strong believer of the expanded value proposition of Pharmaceutical Medicine as discipline bridging Research and Development with the practise of medicine and patient access to optimal care.

^{1 EMAUD: European Market Access University Diploma
2 GFMD: Global Fellow in Medicines Development
3 CME: Continuing Medical Education
4 EFGCP: European Forum for Good Clinical Practice}

Eric was elected President-Elect in December 2023, filling a vacant seat. Eric is the representative from the Dutch member association, NVFG, in which organisation Eric has been a board member since 2021, and has since then chaired the ClinOps division of NVFG (2021-2024) and has functioned as vice-chair in the NVFG board.

Eric has spent 30+ years in the pharmaceutical industry. After studying medicine, the choice was made to opt for a career in this field. Eric has held many roles, amongst which data-manager, CRA, Project Lead, Program Manager and QA consultant. For almost 25 years Eric has worked as a clinical research trainer, 16 of those independent, and he added auditing to his portfolio about 8 years before ending his last independent stint. Since October 2021, Eric works for IQVIA, for 2 years as the DCT Regulatory Director, and currently as Director Information Governance and Privacy.

Until 31 October 2020 Dr Romano (MD, PhD, GFMD1) had, in his position of Executive Medical Director at Covance, full responsibility within the Medical Department including Clinical Development, Medical Support to Clinical Operations, Medical Monitoring and Medical Support to Pharmacovigilance Services. He left Covance and retired on 31 October 2020.

Dr Romano has over 30 years of pharmaceutical development experience, both in pharmaceutical companies and in clinical research organizations (CROs). He has successfully managed a number of Phase II, III and IV clinical trials, and, since 1998, has held senior management positions within the CRO sector such as Country Manager, Medical Director, and Chief Medical Officer.

Dr Romano obtained a diploma in Medicine at the University of Genoa (1983) followed by a post-graduate degree in Hygiene, Epidemiology and Public Health (1987), and another post-graduate degree in Clinical Pharmacology (1994). He is co-author of several scientific papers concerning mutagenesis and carcinogenesis, pharmacokinetics and pharmacodynamics of chemical compounds and glutathione metabolism.

Dr Romano has been a Member of the Italian Medical Association since 1983 and was President of the Italian Society of Pharmaceutical Medicine (SIMeF) from 2014 to 2020. He has been elected President of IFAPP for the period of 2020-2022.

^{1 GFMD: Global Fellow Medicines Development}

Nikos Tsokanas, BSc (Hons), MSc, MBA, Six Sigma Black Belt Certified, is a lean-thinking digital leader with over 20 years of experience in the Pharma Industry, strong IT capabilities and strategic vision, keen bottom-line focus, and verifiable success in optimising efficiency and increasing quality of results through delivery of value-added services and novel technologies. Proven track of success enhancing agile Project Management, creating and maintaining processes, organising audit, managing budgets, and providing updates on project status in large pharmaceutical companies across the UK and Greece. Demonstrating in-depth knowledge of digital capabilities, GxP validation and regulatory frameworks. Elite communicator combined with the ability to convey information in a clear, focused, and concise manner.

Nikos Tsokanas has held different positions in BAYER HELLAS S.A, Athens, Greece since 2015: Quality System Manager, developing and maintaining high-standard Quality Management System for local R&D functions; Head of Medical Operations & Quality System with responsibilities to ensure that medical operational activities in Bayer Hellas are efficiently executed, while leading a group of 3 direct reports; Medical Operations & Excellence Cluster Head, managing medical operation activities across a cluster of five countries, while leading a group of 5 direct reports and with temporary assignment as Medical Digital Lead for EMEA, ensuring digital excellence across Medical teams, integrating and optimizing digital solutions for customer engagement within Medical Affairs throughout Europe, Middle East and Africa.

Within professional development, Nikos obtained the the following qualifications:

• Practical Approach to Audit Systems by Research Quality Association, UK
• Audit Programs & Risk Assessment by Research Quality Association, UK
• Auditor/Lead Auditor of Quality Management Systems (ISO9001:2008) by University of Piraeus, GR
• Project Management Professional (PMP) Certification preparation (35 hrs) by Critical Path Consulting, GR
• Good Clinical Practice Auditing – Principles and Practice by Research Quality Association, UK
• Certificate on Good Clinical Practice by Astra Nova Ltd, UK
• SIX SIGMA, Black Belt Certification by Aveta Business Institute, US
• Management of ICSRs and Medicinal Products in EudraVigilance by Drug Information Association, EU

Currently, Nikos is member of the Board of Directors, Hellenic Society of Pharmaceutical Medicine (EL.E.F.I.), Greece (institutional member of IFAPP) and of the Research Quality Association. Previously, he acted as Secretary of Digital Information Governance & Information Technology Working Group, Research Quality Association, UK and was member of International Society of Pharmacovigilance, Drug Information Association and Pharmacovigilance Group at SFEE.

Dr Jurczynska was elected Secretary of the Board of Officers in June 2021. She is an Independent Consultant and Co-founder of ANMAR Clinical Services and has an MBA¹ from the University of Warsaw, Poland, and a PhD in Social Sciences with a specialisation in Health Care. She has a broad experience in the pharmaceutical industry (Upjohn Farmoquimica, Serono and IMTIX Sangstat) in Medical, Regulatory, Medical Science Liaison (MSL) and Marketing Departments.

Her main commitments were related to local and international clinical operations while in the Medical Department, with large responsibility for timely submission of Clinical Trials dossiers, correct performance and adequate outcomes and results of the trials. In the Regulatory Department, she was accountable for the supervision and development of new product registration dossiers for submission to Spanish Health Authorities and/or to the EMA². Her position in the Medical Science Liaison and Marketing Departments was mainly related to contacts with Key Opinion Leaders and development of clinical protocols for post-authorisation studies.

Dr Jurczynska had a direct responsibility as General Manager of Business Administration at PAREXEL International, being its legal representative in Spain and overseeing all clinical and business operations in the country.

• ¹MBA: Master of Business Administration
• ² EMA: European Medicines Agency

Priv. Doz. Dr med Ghazaleh Gouya was elected Chair of the Communication Working Group. As founder of the Gouya-Insights KG, Dr Gouya takes leadership in clinical development for biotechnology, pharma and medical device companies to address clinical product development and regulatory compliance challenges. The cornerstone of this success is found in an expert team of scientists and medical experts in life science research. It is this insight that allows Gouya Insights to drive the clients from discovery through testing, clinical trials, regulatory approvals, and ultimately arrive at market in the most efficient manner.

Dr Gouya is board certified in Internal Medicine, Cardiology and Clinical Pharmacology, with more than 20 years of clinical and research experience. After clinical practice in internal medicine and cardiology in UK and Austria, she joined the cardiovascular research team at the Department of Clinical Pharmacology, Medical University Vienna, Austria. During her stay at the Medical University Vienna, she finalized her training in cardiology focused on heart failure disease management.

While working at the Department of Clinical Pharmacology Dr Gouya gained fundamental clinical research experience (investigator driven and industry sponsored cardiovascular and metabolic studies). She participated in clinical trials as sub- and principal investigator where she was responsible for developing concept, design, protocol, performance, and management strategies for clinical phase I-III trials in the cardiovascular and metabolic area. Dr Gouya published more than 30 research papers in peer reviewed journals and 3 book-chapters and actively participated in national and international congresses. In March 2015 she was awarded the title Associate Professor for Internal Medicine from the Medical University Vienna with her habilitation thesis “Efficacy and Effectiveness of Antithrombotic Therapy”.

In 2008 Dr Gouya successfully applied, together with a large group of representatives of FP7 clinical infrastructures and EFPIA members, for a European funded project (Innovative Medicines Initiative, IMI) of education and training in medicines development (www.emtrain.eu). She was scientific head and head of communication of EMTRAIN until 2012. After her academic career, she joined a global CRO as medical director. Dr Gouya has been involved in a number of product development processes where she substantially added to the strategy for the project and protocol development in identifying the best approach for the right patient at the right site up to the completion of documentation for market approval. Dr Gouya is a member of the Austrian association GPMed.

Professor Kotone Matsuyama GFMD¹ was elected Chair of the Ethics Working Group in June 2021. From June 2019 to June 2021 she was Secretary of the Board of Officers. She is currently Professor, Department of Health Policy and Management, and Vice President of Center for Strategic Research Initiative, Nippon Medical School.

Professor Matsuyma graduated from Kyoto University Faculty of Pharmaceutical Science and obtained a license as Pharmacist. She started her Research and Development (R&D) career as a data manager in 2003 and she has worked as a project manager since 2005. She spent 12 years at the Translational Research Informatics Center, Foundation for Biomedical Research and Innovation, Kobe, and 2.5 years as a Lecturer at the Center for Quality Assurance in R&D, Kyoto Prefectural University of Medicine.

Professor Matsuyama has been a member of the Board of Directors of the Japanese Association of Pharmaceutical Medicine (JAPhMed) since October 2018. She is also a Project Coordinator, Clinical Development, Program for Drug Discovery and Medical Technology Platforms, RIKEN Research Cluster for Innovation, an adjunct Lecturer, Clinical Pharmacology, Faculty of Medicine, Oita University, and an adjunct Lecturer of Bioethics, Faculty of Medicine, Kyoto Prefectural University of Medicine.

Professor Matsuyama has managed or supported many R&D projects initiated from academia, not only for drugs but also medical devices and regenerative medicines. Her specialty is process optimisation throughout a project, recently known as a clinical planning method using Quality by Design. She won awards of excellence at the 36th annual congress of the Japanese Society of Clinical Pharmacology and Therapeutics and the 7th annual congress of the Japan Society of Clinical Trials and Research.

Her secondary research area is research ethics, and she lectures many educational ethics programs in academia. Professor Matsuyama started her research programme in ethics with Professor Kouichi Setoyama, Kyoto Prefectural University of Medicine, especially on the evaluation methodology to visualise ethical decision-making in medical research. She collaborates with the Japanese AMED grant project named “Development of a Model Evaluation Program of the Effects of Research Ethics Education with an Interdisciplinary Approach.” Professor Matsuyama is a member of the Japanese association JAPhMed.

• ¹GFMD: Global Fellow Medicines Development

Dr Birka Lehmann was elected Chair of the Certification and Education Working Group in June 2021. She has been Senior Expert for Drug Regulatory Affairs and Lecturer at the University of Bonn, Germany, since 1998.

Dr Birka Lehmann studied Medicines at the Free University Berlin and trained at the paediatric clinic (Kinderklinik) Norderney in Germany. Her working experience includes 9 years preclinical assessment in the division ‘Pharmacology and Toxicology’ of the German Medicines Regulatory Agency (BfArM¹) and she served as Head of Unit ‘Decentralised Procedure’ (1996 – 2002) and as Deputy Head of the EU Division (2000 – 2002). She was a member of and chaired the Mutual Recognition Facilitation Group and served as expert to the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA). From 2002 – 2006 she joined the Directorate-General Enterprise and Industry of the European Commission as expert on secondment to the unit ‘Pharmaceuticals’ responsible for inter alia Marketing Authorisation and implementation of the Clinical Trials Directive.

From September 2006 to October 2011 Dr Lehmann was Head of Division 3 Marketing Authorisation procedure at the BfArM comprising several indication areas including cardiovascular and pulmonary diseases, antibiotics and dermatology. Dr Lehmann was then Head of the Executive Department EU and International Affairs of the BfArM from October 2011 till the end of 2015 and she was a member of the Paediatric Committee at the European Medicines Agency from 2007 to 2016. Dr Lehmann is a member of the German association DGPharMed.

• ¹BfArM: Bundesamt für Arzneimittel und Medizinprodukte (Federal Institute for Drugs and Medical Devices)

Robert Lins is MD and certified specialist in Internal Medicine, Nephrology and Hypertension. He has a PhD in Medical Sciences, is European Hypertension Specialist and Fellow of the Belgian College of Pharmaceutical Physicians. He was a Clinical Professor at the Department of Internal Medicine, University of Antwerpen. Since many years he is a board member of the and currently the President. He is member of different local and international scientific societies and was most recently president of the Belgian Association of Clinical Research Professionals (ACRP.be), now Healixia.

He worked during many years as director of the department of Nephrology-Hypertension at Stuivenberg hospital in Antwerp, Belgium, before becoming general manager of one of the hospitals, belonging to the Hospital Network of Antwerpen (ZNA).

He started a Clinical Pharmacology Unit in Stuivenberg hospital in 1987, that was acquired later by SGS. From 2007 until 2011 he was Managing Director of SGS Life Science Services Clinical Research. Since then, he is continuing his activity as a consultant. Currently he is Managing Director of Linsconsulting and Project Director Respiratory Diseases for SGS Life Sciences. He published over 100 articles in international peer-reviewed journals.

Joanne Ramsey PhD was elected chair of the Young Professionals Working Group in December 2023. She joined IFAPP in 2021 as an Individual Affiliate and is a member of the Education and Certification Working Group and the Communications Working Group. In 2023 she also served as the IFAPP delegate for the PharmaTrain Syllabus Revision Project with the PharmaTrain Federation.

Joanne trained as a Biomedical Scientist and worked in NHS laboratories in Northern Ireland. She went on to obtain her PhD from the Centre for Cancer Research and Cell Biology at Queen’s University Belfast in 2011 studying small molecule therapies in malignant diseases and helped in their establishment of retrovirus technologies.

Upon completion of her PhD, she took up a pharmaceutical research position in the Royal College of Surgeons in Ireland (RCSI) working on Advanced Therapy Medicinal Products and tissue regenerative medicine. Dr Ramsey has been involved in two invention disclosures, gene therapy patent applications and is co-author of publications in gene therapy, oncology, models of disease and pharmacogenomics. In 2015 she became a pharmaceutics lecturer and principal investigator in RCSI and obtained her postgraduate qualification in Health Professions Education.

Joanne then moved to Trinity College Dublin in 2019 to take up the position of Assistant Professor in Pharmaceutical Medicine and is the Pharmaceutical Medicine course coordinator in the School of Medicine’s Pharmacology and Therapeutics department. Her current research activities include biotherapeutics applications and regulatory science in women’s health.