A review of the future landscape of global clinical trials and perspectives for the CEE region. Insights into trends and projections (in biotech, genome diagnosis, gene therapy, personalised medicine, etc). Global factors affecting clinical trials in CEE: how can the region strengthen its competitive advantage?
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.
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
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.
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.
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.
How to develop better practices and implement new technologies for a clinical trial supply chain in CEE countries?
How to overcome potential operational challenges in clinical trials?
The ways Air Cargo industry can improve the handling of pharmaceutical shipments
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.
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
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
1-to-1 meetings offer an invaluable opportunity to meet and collaborate with pharma & biotech executives and CROs - in person. Leading companies will be represented by their clinical research specialists. Meetings will last 10 minutes, allowing you to introduce your company and service, align your offerings, and establish direct contact with top managers for future collaboration.
The number of meetings available is limited. Register your delegate place early for priority in booking meeting slots with Pharma, Biotech and CRO leaders!