Dr Oleksandr Gorbenko is an expert in public health, patient advocacy and engagement with overall 18 years experience in pharma. He graduated as a medical doctor (general practice) in O.Bogomolets National Medical University and Shupyk National Medical Academy of Postgraduate Education and later worked on his PhD dissertation in the Ukrainian Institute of Public Health MOH. His experience across pharma includes several medical and commercial roles in representative offices of big biopharma companies (Nycomed/Takeda, Richter Gedeon, GSK) as well as senior global medical roles at GSK and ViiV Healthcare headquarters in the UK. He has an additional experience with UN/UNFPA on women empowerment and combating gender-based violence. Over the last 5 years Dr Gorbenko has been developing necessary capacities/capabilities within corporate patient affairs focusing on getting insights, advice and information from patients throughout the Medicine Development Continuum and disease continuum/individual experience, collaboration with patient organisations, substantiation and inclusion of the specific PRO/PCO measurements, KPIs and standards of patient centricity for big pharma and other programmes. ViiV Healthcare has been broadly recognised as a truly patient-centric company (Number 1 amongst 47 biopharma companies over the last 5 years by PatientView Corporate Reputation Ranking) and reliable partner of HIV community.
Dr. Vesna Popovska has successfully developed and established the Neurosciences Research Program at BC Children’s Hospital. She leads the entire research program including the Division of Pediatric Neurosurgery and Division of Pediatric Neurology. She has pioneered the concept of a research manager running different research programs in the Children’s & Women’s Health Centre of BC, which now serves as a model for building similar research programs at BCCH and other hospitals in BC and Canada.
Dimitris Zampatis, MSc, PhD, is an Associate Director, Signal and Risk Management Process at Merck Biopharma. He holds a BSc in Biology, a MSc in Medicinal Chemistry: Drug Design and Development and a PhD in Cell and Molecular Biology.
In his current role he is responsible for the development of the company’s benefit-risk assessment framework, the signal detection strategy e.g. quantitative and qualitative signal detection methods using internal and external databases (EVDAS, VigiBase, FAERS, VAERS, JADER) as also the Risk Management and risk minimization measures processes and implementation.
Through his career Dimitris gained substantial knowledge and experience in different aspects of Drug Safety and Pharmacovigilance such as Signal Detection, RMPs, PBRERs/PSURs, DSURs, safety communication (e.g. Direct Healthcare Professional Communication/Dear Investigator Letter). He participated in various successful FDA and EMA submission applications either as a team member or as team leader.
Dimitris is also a Pharmacovigilance tutor and trainer and participates in various conferences as a speaker.
Piotr Iwanowski is an Assoc. VP Clinical Research Europe at Wockhadt Bio AG, as well as national board member of Polish Association for Good Clinical Practice (GCPpl).Within the GCPpl Association he is the head of the standing working group on ethics review of clinical trials. His particular interest are clinical studies in special populations (emergency trials, patients not mentally competent to consent, paediatric trials); he had also published in that domain.
In the past he had organized a large international conference in Poland dedicated to biomedical research in emergency settings.
In his home country Piotr is leading the lobbying activities towards the ethics committees and the regulator with regards to establishing a new system for ethics review of clinical trials in view of the forthcoming applicability of the EU Clinical Trial Regulation.
Piotr has been speaking at multiple international and national conferences dedicated to clinical trials; he is also a lecturer at two postgraduate study programmes at Warsaw universities.
Francisco Rizzuto (49), Economic Analyst – MBA Degree specialist in International Trade & Cargo Transportation with 25 years of experience in the industry. Also specialist in Freight Management of Temperature Controlled Shipments for Pharmaceutical Products. Validator and Instructor of IATA's CEIV Pharma Handling Certification program having performed several Assessments and Trainings in different Airports in Europe, United States, Canada, South Africa and Latin America. Speaker and panelist at specialized events, congresses and conferences in Europe on Air Cargo Supply Chain for Pharmaceuticals. Instructor for the IATA Pharmaceutical Handling Diploma on Risk Management, Air Cargo Operations, Audit and Quality for Temperature Controlled Shipments. IATA Consultant on projects at European Airports for Freight Forwarding Companies, Airlines, Ground Handling Companies and Trucking Companies part of the IATA CEIV Certification on Air Cargo Handling for Pharmaceuticals.
Michaela is chemical engineer with 12 years of experience in clinical research, from CRA, LCRA, PM in both CROs and big Pharma companies up to finding Slovak research center, where she is the Clinical Operations Director. Previous companies: Icon, KCR, Octapharma, Boehringer Ingelheim. Slovak research center is a member of Society of Clinical Research Sites, where Michaela is active in more Site Advocacy Groups.