Key Speakers presenting at the conference will give out updates about Eudravigilance at one-year from the implementation of the new requirements, latest implementation of the new requirements, latest inspection Trends in Pharmacovigilance, how the Signal Detection process is changing, which is the impact of the new requirements on the PhV process as well as deepen PhV quality system. Specific focus will be given on Patients Support Programmes (PSP) and engagement for the set up of appropriate risk management and risk minimization measures.
Glyn Belcher, M.D.
Expert in Signal Detection/Risk Management - CEO of PV Concultancy Ltd - Former Vice President of Biogen
Head of International Drug Safety & Risk Management - EU QPPV
Dr Glyn Belcher has over 30 years experience in clinical development and drug safety in the pharmaceutical industry. Dr Belcher qualified in medicine from Oxford and Cambridge universities and received his PhD in neuropharmacology from the latter. After a number of years in hospital internal medicine he joined Schering and worked in clinical research in the UK affiliate before moving to headquarters in Berlin, first as head of cardiovascular clinical research and later as head of a new safety department covering clinical development activities. Dr Belcher moved to Takeda European Research and Development Centre in London where he was Director of International Drug Safety and EU QPPV for nine years. He most recent full-time position was as Head of Drug Safety and Risk Management and EU QPPV at Biogen Idec in UK. In this position he took a lead role in the safety aspects of the European approval and post-marketing surveillance of Tysabri and other Biogen medicines. After retiring from this position, he has continued to consult for Pharmaceutical Industry companies as well as committing more time to teaching and mentoring in the areas of pre-marketing and post-marketing drug safety and benefit risk management.
QPPV - Dompé Pharmaceutical Spa
Short Bio coming soon..
Mario Bertazzoli, M.D.
Director, Head Corporate Drug Safety at Helsinn SA
Mario Bertazzoli is a physician and a registered specialist in Human Reproduction Pathology. He received both medical and specialization degrees from the University of Milan, Italy and worked as physician at the Obstetric and Gynaecological Department, University of Milan and for the Italian National Health Service, district of Milan.
Since 1995 he worked for international pharmaceutical companies as pharmacovigilance and pharmaco-epidemiology physician. In the year 2001 he was appointed Head of Corporate Drug Safety and EU Qualified Person for Pharmacovigilance and from the year 2009 Director, Group Head of Drug Safety and Reference Physician to the EU Qualified Person for Pharmacovigilance for the Helsinn Group.
He is Founder and Treasurer of the International Society of Pharmacovigilance, Swiss-Austrian Chapter.
Davide Bottalico, M.D.
Digital Healthcare & Innovation - Director Takeda Italia
MD specialized in Nephrology in 1997 in Parma. Always passionate about information technology and digital implementations, he holds numerous positions in pharmaceutical companies such as Dompé Biotech, Roche Diagnostics and Roche Pharma. Since 2012 he has held the role of Country Digital Leadership supervising all the digital activities of Roche Italy. In this role he is the author of numerous initiatives in the field of digital health.
Thanks to an educational project, the Digital Academy, realized with the IULM University of Milan, in 2013 he won the prestigious Social Media Pioneer Award USA, an award dedicated to pioneering pharmaceutical multinationals in the field of digital marketing. Since 2015 he has been Digital Director of Takeda Italia in this role winning the Le Fonti Awards for the best Digital Team in the pharmaceutical field for 2 consecutive years.
Gian Nicola Castiglione, M.D.
EU QPPV & Director Global Pharmacovigilance - Chiesi Farmaceutici
Dr. Castiglione graduated in Medicine and Surgery at the University of Bologna. After a brief experience as an ISF at Eli Lilly Italia, since 1991 he has worked at Chiesi Farmaceutici S.p.A. (Parma). He has gained experience in clinical research, in particular phase II and III studies. Since 1997 he has been involved in Pharmacovigilance.
He currently holds the position of Director of Global Pharmacovigilance and EU QPPV of Chiesi Farmaceutici S.p.A.
Contract professor at the Faculty of Pharmacy of the University of Parma, he has been a master teacher and speaker at seminars and training courses on pharmacovigilance.
He is also member of the Pharmacovigilance Group of EFPIA and Farmindustria.
Legal Director & Senior Counsel Italy & Greece at Amgen
Mature, business savy lawyer with 14 years of PQE experience working in highly regulated markets (pharmaceutical and cosmetics), excellent interpersonal skills able to work successfully cross-functionally. I am a senior in-house lawyer able to offer counsel on a variety of legal issues; strongly business-oriented manager, able to operate within international matrix environments.
Vice President- Head of Patient Safety and Pharmacovigilance at Kite Pharma
David Chonzi is the Global Head of Patient Safety at Kite-a Gilead company. At Kite he was responsible for building the PV system, the team as well as the leading the safety strategy analysis and communication to support YESCARTA approval in the US and EU. The Kite Patient Safety team is also responsible for monitoring for the safety of all cellular therapies at Kite Gilead. David also led the integration activities of the Kite PV operational system into the Gilead system as part of the harmonization post acquisition. He is one of the industry representatives for the teams overseeing the Cellular Registries in the USA (CIBMTR) and in Europe (EBMT). Prior to Kite, he was the PV Safety Lead for the Immuno-Oncology programs at Genentech-Roche and led the activities which supported approval of atezolizumab. His experience in PV include work on REMS, RMP, Registries, Filing activities and due diligence activities
David received his MD degree from the University of Zimbabwe and trained in Internal medicine in UK. He also holds an MSc in Epidemiology from London University.
Mircea Ciuca, M.D.
Global Head Medical & Clinical Drug Safety - Vifor Pharma
Mircea Ciuca, MD is currently Global Head of Medical & Clinical Drug Safety at Vifor Pharma in Switzerland. He is leading a team of scientists and physicians involved in all aspects of pharmacovigilance, in both development and post-marketing settings.
Mr. Ciuca has about 13 years of experience in drug safety. Prior to join Vifor Pharma he held various positions (Deputy QPPV, Senior Pharmacovigilance Medical Manager, Drug Safety Advisor) at large pharmaceutical companies in The Netherlands, after successfully establishing and leading the medical-scientific department of a medium-size CRO in Rotterdam.
After graduating from University of Medicine and Pharmacy in Bucharest Romania, he became specialist in Emergency Medicine, and later in Obstetrics & Gynecology. He was involved in clinical practice and academic teaching for about 12 years. Later he has completed postgraduate studies in Pharmacovigilance at University of Hertfordshire, UK.
QPPV Italfarmaco Spa
Dr. D'Antuono graduated in Pharmacy in 1995 at the University of Rome "La Sapienza" and received her PhD in Neuroscience at the University of Rome "Tor Vergata" in 1999. From 1995 to 2007 she worked on preclinical research in neurology in Rome and at the Montreal Neurological Institute, McGill University, Canada. As part of this activity, she is co-author of over 30 articles published in indexed journals. Since 2008, Dr. D'Antuono has been professionally involved in Pharmacovigilance and since 2016 she held the role of EU-QPPV at Italfarmaco S.p.A.
Fabio De Gregorio, M.D.
Vice President, Head of Drug Safety Europe, EU QPPV - Shionogi Limited
Dr De Gregorio is a physician with more than 14-year experience in PV and drug safety, 10 out of which spent as Qualified Person for Pharmacovigilance. Prior to moving into the pharma industry, he specialised in ophthalmology, gained a Ph in pathophysiology of ocular microcirculation and exercised medical practice for 20 years. He is a registered physician with the General Medical Council.
Among his achievements, he successfully set up, maintained and managed the pharmacovigilance system of several small medium enterprises, contributed to the development of an innovative treatment for ocular hypotony from pre-clinics to the marketing application and actively participated to the clinical development of products indicated for glaucoma, neuroprotection, amblyopia and dry eye therapy.
He is also author of several scientific papers and book chapters on ophthalmology, published on Italian and international peer reviewed journals.
Specialties: pharmacovigilance; safety signal detection and management; clinical development of ophthalmic products.
Former Head of Pharmacovigilance Dept. - Italian Medicines Agency
Scientific Board - PEC (Pharma Education Center)
Former GMP inspector, has gained long experience as GMP inspector and director, first in the Ministry of Health where he served from 1984 to 2004, and later at the Italian Agency for Medicines (established in 2004). From 2009 to 2013 she has been involved in the safety of medicines (as Director of the Pharmacovigilance Office and alternate member of the PRAC - Committee for Pharmacovigilance Risk Assessment of the European Medicines Agency EMA in London). From 2013 to 2015 has verified regulatory compliance due to the updating of the registration dossiers and CTDs of the medicines by MAH companies, in particular in case of GMP production API production delays and semi-finished / finished products.
Teacher on GMP and Pharmacovigilance issues in several University Masters and Training Courses. Speaker at numerous scientific congresses
Senior Director Worldwide Safety & Regulatory - Pfizer Pharmaceuticals
Dr Eichorn did his medical training in the US and practiced general adult medicine in the outpatient and hospital settings for 10 years before joining the pharmaceutical industry. He joined Pfizer (UK) in 2002 and since then has served a number of roles in the safety and risk management, including provision of cross-portfolio guidance on the RMP. Much of his current work also focuses on partnering with commercial, medical and other non-safety colleagues to promote the quality of AE reports resulting from market research support programmes, patient support programmes, and other activities that involve communication between the company and HCPs, patients and consumers.
Giovanni Furlan, M.D.
Safety Risk Lead Director- Pfizer
Qualified Pharmacist with a degree in Chemistry & Pharmaceutical Technology with t 20 years experience in the Drug Safety , Dr. Furlan started with processing cases in a major pharma Company. Since then he had setup, developed and managed drug safety units, integrating the safety operations of two pharmacovigilance departments.
Qualified Person Responsible for Pharmacovigilance (EU QPPV) and Local Responsible Person for Pharmacovigilance, he leads a team of doctors in charge of analyzing the Company’s products envolving safety profiles.
He collaborated with national, European and global level in medium and big pharma and in a CRO and he is also an expert in all aspects of the pharmacovigilance system, preparation of aggregate reports, signal detection and evaluation, risk management plans, interaction with regulatory authorities.
Successfully undergone a number of audits and inspections, he deliveres presentations in major congresses and has published many articles on various pharmacovigilance topics.
In 2018 Dt Furlan has been awarded with the International Award of Excellence Pharma Awards 2018 – winner in category “PV thought leader”.
From October 2018 he joined Pfizer as a Safety Risk Director.
Damon Green, M.D., M.S.
Medical Safety Surveillance Officer at Emergent BioSolutions. Former Medical Officer at FDA (CBER and CDER); active member of the American Medical Association and the American College of Preventive Medicine
Damon Green, MD, MS, has recently joined Emergent BioSolutions as a Medical Safety Surveillance Officer. Prior to joining Emergent, Dr. Green served as a Medical Officer with the U.S. Food and Drug Administration firstly as an epidemiology reviewer conducting pharmacovigilance for the Center for Biologics Evaluation and Research, secondly as a member of the Professional Affairs and Stakeholder Engagement Staff for the Center for Drug Evaluation and Research, and lastly as a reviewer in CDER’s Office of Compliance-Office of Scientific Investigation, GCP Assessment Branch. He is also an active member of the American Medical Association and the American College of Preventive Medicine.
Dr. Green received his Medical Doctorate and Masters in Epidemiology from the University of Maryland School of Medicine in Baltimore, and completed specialty training in both Anesthesiology and Preventive Medicine. Dr. Green transitioned to Public Health practice and the pharmaceutical industry after 12 years of clinical practice as a General Anesthesiologist and participation in the Clinical Safety and Pharmacovigilance fellowship program of Otsuka Pharmaceutical Development & Commercialization.
Calin A. Lungu, M.D.
MD, MRQA, BCMP
Eudravigilance and XEVMPD - EMA
CEO - DDCSDr. Calin A. Lungu is the Chief Executive Officer of Drug Development Consulting Services (DDCS), a pharmacovigilance quality assurance consulting firm located in Luxembourg. He has worked for 15 years in drug development, clinical research, pharmacovigilance and quality assurance. Dr. Lungu has worked for a biotechnology company since 1993, and since 1995, as an independent consultant. Since 1999, he founded Drug Development Consulting Services of which he is presently CEO and which provides services in the area of quality assurance for pharmacovigilance.
Dr. Lungu has been a professional trainer in the use of the EudraVigilance Data Analysis System for European National Competent Authorities and the European Medicines Agency between 2008 and 2012. He is also an active member of the DIA, the British Association for Research Quality Assurance (BARQA), the Belgian College of Pharmaceutical Physicians, the Belgian Association of Physicians from the Pharmaceutical Industry (ABEMEP) and various other non for profit organisations.
He graduated from the Free University of Brussels, Belgium and became MD in 1992, the same year he joined the pharmaceutical industry.
Expert Patient of EUPATI (European Patient's Academy for Therapeutic Innovation)
Paola Kruger has a background in EU Public Affairs and has worked in London, Brussels and Rome. Since being diagnosed with a chronic disease in 2010 she has turned her attention to Patient Advocacy and she has been working with the Multiple Sclerosis Centre of a large hospital in Rome helping healthcare professionals to participate in EU initiatives and developing patient-centric projects, as well as focusing on having patients more empowered and proactive in their care path.
She has participated in the IMI-funded project EUPATI (European Patient Academy on Therapeutic Innovation)whose aim is to train patients on the R&D of medicines and graduated in 2016. Since then she has been officially listed by EMA as an EMA Expert and she is speaker at numerous national and international events especially on the subject of patient involvement in clinical research. She also represents patients in several boards and Scientific Committees.
Associate Director Pharmacovigilance, Deputy European Qualified Person for PhV - Shionogi Limited
Valentina Mancini graduated in Pharmacy, at the University “La Sapienza” in Rome
After three years of experience working in public pharmacies (including position of rural Pharmacy Director), in 1998 joined Pfizer Italy Medical Department, in the Drug Safety Unit.
In 2000 she moved to Takeda Italy, where she held several positions, with constantly increasing responsibilities, in the areas of Quality Assurance, Pharmacovigilance and Medical Information, also being EU QPPV for two years.
In 2017 she joined Baxter Pharmacovigilance, where she was responsible for the Southern Europe cluster (Spain, Portugal, Greece and Cyprus).
From January 2018, she is in Shionogi European Pharmacovigilance, with the role of Associate Director Pharmacovigilance, Deputy QPPV.
Valentina has also conducted relevant external lecturer activities, including teaching at Verona University (Post Graduate Master’s degree in Pharmacovigilance and Regulatory sciences) and at Piemonte Orientale University (Post Graduate Master’s degree in Regulatory matter and Market Access).
Manager / EMEA Pharmacovigilance Agreements Baxter S.L. - Baxter Spain
Bachelor of Pharmacy and Master in business administration of pharmaceutical industries, Dr. Martinez began her experience in the pharmaceutical company, where she was in charge of new business Development, Regulatory affairs , product development and registration, activities for broad range of Hospital products including generics and non-generics specialities .
In 2007 moved to Baxter S.L. company and so far she has dealed with formulation, review, update and compliance of Safety Data Exchange Agreements (SDEAs- Pharmacovigilance agreements) for potential and active third party activities across EMEA region.
MSc, PhD, PgD Head of Global Pharmacovigilance & Drug Safety at InsudPharma, Spain
Jørgen Matz, MSc, PhD, PgD is the Head of Global Pharmacovigilance & Drug Safety for InsudPharma, Madrid, Spain which is a healthcare company with business units for worldwide manufacturing, development and marketing of branded, generic and biotechnological products. Dr. Matz has previous working experience from H. Lundbeck, acting as Global Head of Medical Safety & Risk Management in Copenhagen, Denmark. He has a background as an experimental pharmacologist and in translational medicine. In recent years he focussed on implementing pharmacovigilance systems tailored to support a continuous benefit-risk assessment of marketed products.
Jose Alberto Ayala Ortiz
PVpharm CEO, EU QPPV, EudraVigilance EVWeb-XEVMPD Trainer, Pharmacovigilance Consultant, LCPPV Services Spain, GVP Audit
José Alberto Ayala Ortiz (M.Sc. Pharm. and M.Sc. IT) is an expert in the field of Pharmacovigilance and Drug Safety. He has experience both from the Regulatory (Danish Medicines Agency), and from the Pharmaceutical Industry, where he has been responsible for Pharmacovigilance IT systems, databases and Electronic transmissions. Besides his day-to-day Pharmacovigilance work as a consultant/CEO of PVpharm, he is an active trainer of the EVWeb and XEVMPD training courses since 2003, and collaborates together with the training team, the EMA and the DIA in the development of these training courses, as well as the Signal Management trainings. He provides also EU QPPV services in the EU and local QPPV services in Spain for Pharmaceutical Companies.
GVP Senior Inspector - AIFA
Graduated in Pharmacy at the University of Rome "La Sapienza", specialized in Pharmacoeconomics and Pharmacology and with an expertise in preclinical and clinical development of medicines. At the Italian Medicines Agency (AIFA) since 2004, he was in charge of monitoring, analyzing and assessing reports on suspected adverse drug reactions and periodic safety reports, and management of the renewal of Marketing Authorization of medicines. He was a member of the research and development group (Gdl-R & S) that met the investigations of independent research projects on drugs. In collaboration with the European Medicines Agency (EMA) and other Agencies he took part in the evaluation of the safety profile of medicines and in the adoption of specific regulatory measures. Since 2009 he has been in charge of Pharmacovigilance inspections as GVP Senior Inspector increasing his expertise in the Pharmacovigilance systems and their quality systems. As an EMA expert he take part at the Pharmacovigilance Inspectors working group (PhV IWG) of the EMA of which he is liaison member with the Eudravigilance Working Group (EV EWG). He is assessor for the Benchmarking of the European Medicines Agencies (BEMA). He has been lecturer in university master's courses and in national and international training courses, and speaker at numerous conferences and seminars. Currently he works in the Inspections and Certifications Department of AIFA.
Pharmacovigilance Consulting, Pharmacovigilance & Drug Safety Manager of Phast Consulting
Graduated in Chemistry and Pharmaceutical Technology at the University of Milan in 1998, Dr. Rotunno has 20 years’ experience in the pharmaceutical companies starting from the Regulatory Affairs and Pharmaceutical Technology Development field.
Former EU QPPV for many years at DOC Generici S.r.l., she gained a wide experience in the pharmacovigilance systems, being involved directly in almost all pharmacovigilance processes, from case processing to signal detection and risk evaluation and minimisation activities.
Certified ISO 9001:2015 and Lead Auditor, she is also involved in the set up of quality systems of the pharmacovigilance system and in pharmacovigilance audits.
Lecturer at the “Master di II livello in Farmacovigilanza” University of Milan, and at the “Master in Discipline Regolatorie” University of Pavia, member of SFFA and AFI Pharmacovigilance group, currently she is a freelance Pharmacovigilance Consultant and shr collaborates with Phast Consulting Srl as Drug Safety Manager.
Chief Pharmacovigilance Officer & EU QPPV ADIENNE Pharma & Biotech
Chairperson for EU PV Congress
Speaker at numerous scientific international congresses, Marco Sardella is the Chief Pharmacovigilance Officer & EU QPPV - Head of Global Safety and Pharmacovigilance in Adienne srl from 2015.
Dr. Sardella has gained a deep experience in Pharmacovigilance matter, starting before as Drug Safety Specialist (2006) and becoming after, the EU QPPV/Drug Safety Manager (2009) in Gentium.
Certified and Experienced Pharmacovigilance Auditor (PV audit to Companies in US, UK, Germany, Italy, France, Switzerland, Czech
Republic, Sweden, Spain, Slovenia, Ireland, Lebanon, Iran, Israel, Turkey, Japan), among his specialties he reckons Drug Safety Management,Post-Marketing
Surveillance, PV Audit, Safety Data Analysis and Signal Detection, Production, Management and Maintenance of Pharmacovigilance and Risk Management Systems, CTD Safety Modules Production,
Reporting to EMA, CAs of European Member States, FDA and Other Authorities.
Francoise Dumas Sillan, M.D.
Vice President, Head Global QPPV office at Pfizer
Francoise Dumas Sillan is the head of the Global QPPV Office and Pfizer EUQPPV based in Italy .
Francoise was graduated in Medicine in Lyon, France, and practiced medicine prior to joining the pharma
industry in Pharmacovigilance more than 25 years ago. She spent 15 years working in Vaccines PV and was
a significant contributor to the development of standard definitions and methods on vaccine safety through
CIOMS WHO working groups. Immediately prior to joining Pfizer, Francoise spent more than five years as
the EU QPPV at Sanofi and Sanofi Pasteur. She has been in charge of the coordination of the international
network of Pharmacovigilance. and analyzed the influence of European pharmacovigilance regulations
outside Europe with the impact of these new non-European regulations on the EUQPPV role
She is a member of Pharmacovigilance Expert Group at EFPIA.
Doris Irene Stenver, M.D. - M.P.A.
Chief Medical Officer and member of Pharmacovigilance Risk Assessment Committee (PRAC), EMA
During 12 years (July 1986 – May 1998) she worked as a physician at university hospitals in the Copenhagen area (Hvidovre, Frederiksberg, Herlev, Roskilde), primarily in departments specialized in internal medicine, nephrology and endocrinology. In 1995 she became specialist in internal medicine. Her clinical experience also covers haematology, cardiology and infectious diseases. Her research activities and publications were primarily within the areas of haematology, immunology, nephrology and endocrinology.
She joined the Danish Medicines Agency in June 1998, initially as senior medical officer; in 2002 appointed chief medical officer (current position). She was member of the EU Pharmacovigilance Working Party from June 1998 until July 2012. Since July 2012 she has been member of the Pharmacovigilance Risk Assessment Committee (PRAC). Her regulatory experience comprises all aspects of pharmacovigilance, including scientific evaluation of drug safety issues, development of risk management strategies, policies and guidelines, provision of scientific advice to the pharmaceutical industry, and communication to health care professionals and the public. Author of several international publications on various aspects of pharmacovigilance.
BERT VAN LEEWEEN, M.D.
Deputy-QPPV of Astellas Pharma
Bert van Leeuwen is the deputy-QPPV of Astellas Pharma. After obtaining his MD he worked in various hospitals for several years. Now working in Pharmacovigilance for over 15 years, he started at Organon leading two Therapeutic Areas, both for marketed products as well as clinical trials, in a quickly growing PV department; he was also closely involved with the implementation of Core Safety Data Sheets, MedDRA and the setup of a Signal Detection system. Thereafter he led the ‘Quality in PV’-group, implementing a Compliance Monitoring system and the PV Intelligence system as well as managing regulatory inspections. After the take-over by Schering-Plough he was actively involved in merging the two PV Quality Document systems. Then moving to Astellas, he led one of the two Therapeutic Groups in PV, before accepting his current role. Next to the daily work he attended many conferences globally since 2000, some as a speaker, most of the time about PV Legislation, Signal Detection and PV Outsourcing; his last publications (in Therapeutic Innovation & Regulatory Science 2017;51;1:11-15 and Pharmaceutical Medicine, 2017, Online First) were on the same subject. He is an active member of a group of PV professionals working on a standard for PV outsourcing.
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