The premier meeting-place for the Clinical Trials sector in Central & Eastern Europe

28-29 May 2019

Hotel Bristol, Vienna

Confirmed speakers

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.

 

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.

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.

Dr Crawley is the Executive Director of the Good Clinical Practice Alliance – Europe (GCPA) in Brussels, Belgium and a World Health Organization (WHO) Expert in ethics. Responsible for the coordination of the Strategic Initiative for the Developing Capacity in Ethical Review (SIDCER). He is a philosopher specialising in legal, regulatory and ethical issues concerning medical research, teaching at several European Universities. He is the past Secretary General, Ethics Officer and Chairman of the Ethics Working Party at the European Forum for Good Clinical Practice (EFGCP) where he also was the editor of the EFGCP news. He is currently Chairman of the Ethical Review Committee of the International Network for the Cancer Treatment and Research Association (INCTRA). He has been a member of the EMVI-AMVTN Ethical Review Committee, a permanent liaison to the International Bioethics Committee of UNESCO.

 

 

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.

Radu Costin Ganescu is the President of the national Coalition of organisations for patients with chronic conditions of Romania (COPAC).

He is also a founding member of the Romanian Association for People with Thalassaemia, which he is heading since 2005. In 2008, he became a voting member in Thalassaemia International Federation.

Radu joined the EPF Board in May 2015.

Roman has more than 10 years experience within the clinical trials area, recently was  acting as Medical Trials Quality Assurance Manager in STADA CIS. He started his career working as Sub-Investigator and continued as CRA in local and international CROs. Before STADA Roman worked as CRA, Senior CRA, Clinical Team Leader and has solid experience mainly in oncology, cardiovascular, psychiatry, rheumatology, neurology, urology, pediatrics and general therapy areas. Systems within his responsibility/area of expertise are: supplier qualification, inspection management, personnel training, internal quality system documentation maintaining, SOP management, risk management, internal and external audits (GCP/GMP, certified as GMP auditor in 2018).

At the moment Roman is working as a Clinical Trial Manager at Avva Rus (AVVA Pharmaceuticals AG) and the scope of his responsibilities are: clinical trials quality control and vendor management.

Seasoned professional in clinical research industry with over 20 years of experience, with expertise in rare disease, pediatrics and medical device.

Managing Director and owner of AXIOM International Contract Research Organization (CRO) operating in the region of ex-Yugoslavia and surrounding countries for over 12 years.

Vice-President of KLINIS Association for Advancement of Clinical Research of Serbia, previously President in 2 mandates since its foundation in February 2012.

Member of EFGCP and MedTech Europe Medical Technology Stakeholder Alliance since its foundation.

Member of the EFGCP Initiative on Patient Information Sheet (PIS) Improvement Working Group.

 

In parallel translator and court interpreter for the courts of law in Serbia and Bulgaria. Also, international lecturer, author of several textbooks and dictionaries.

Dr Raffaele Laciti has 15 years of international experience in the pharmaceutical industry (including Thermofisher, Parexel, Novartis)
Sourcing and category management, business development and account management, procurement and outsourcing, project management, global clinical supply chain and logistics, commercial and clinical packaging, compliance and validation
Academic background
Master in Business Administration (MBA) in Strategic Management (WBS - Westminster Business School, London), UK
CIPS – Advanced Category Management, London, UK
PRINCE 2 project management, Dublin, Eire
BSc & MSc in Industrial Chemistry (Chemical Engineering and Analytical Chemistry), analytical specialisation at the University of Rome “La Sapienza”, Italy

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.

Masha Komnenic

Information Security and Data Privacy Specialist | Certified Data Protection Officer (CIPP/E AND PECB DPO)

Masha has been working as a Data Protection Officer for the past 5 years, helping early stage biomedical startups from UK and Ireland, and has contributed as a mentor on many international business accelerators. She specialises in implementing, monitoring and auditing business compliance with privacy regulations (HIPAA, PIPEDA, E privacy directive, GDPR, PCI DSS, EU-U.S. and Swiss-U.S. Privacy Shield Frameworks). As a DPO of Axion International and a member of the ECHAlliance Ecosystem Serbia she works closely with patient associations, Serbian Government and private medical secretor advising on information security and personal data protection.

Masha studied Law at the Belgrade University and has Masters degree from the Faculty of Law. She has passed the Bar examination in 2016 and got GDPR certification from the PECAB in 2018 and IAPP in 2019.

 

Areas of Expertise:

•             Early Stage Businesses Development

•             Information Security

•             Regulatory Compliance

·                Legal research