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European Pharmaceutical Contractor
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| Ana C Hernandez Daly and Vasiliki Poufti travel the route to clinical trial approval in Greece
When Directive 2001/20/EC entered into force, it bound member states, amongst them Greece, to comply with its specific requirements with regards to GCP implementation in clinical trials (1). This event precipitated the generation and adoption of a significant number of local laws, regulations and administrative provisions over a brief period of time, and which were not necessarily consistent with the interpretation and implementation of other member states.
Companies and the industry as a whole were enthusiastic that countries such as Greece would move forward with the implementation of the Directive in a progressive and efficient way; achieving, ultimately, clearly defined responsibilities and a decrease in process duplication. At this point, Greece became a fast-growing enterprise, particularly in areas such as oncology, cardiovascular and metabolic disorders. However, the onceenvisioned path to effectiveness became littered with obstacles and administrative burdens, which affected critical trial milestones. |
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Ana Cristina Hernandez Daly is a Medical Doctor who has been involved in clinical research since 1999, occupying positions such as Study Coordinator and Investigator at several national institutes in Mexico, with infectious diseases as her primary area of work. She has also occupied other positions, including PM for PPD in Mexico, Central America and the Caribbean, and Marketing Director and Training Director for a group of CROS in Europe. Ana is an external consultant currently providing services in the Balkan region for the clinical trial industry and investigative sites.
Vasiliki Poufti is currently an insourced CRSM at Pfizer in Greece. Previously, she was responsible for CTA submissions in Greece and Cyprus to ECs and regulatory authorities, and contract negotiation with DYPEs. Vasiliki holds a degree in Business Administration and a MSc in Health Care Services Administration and Certification in Pharmaceutical Assessment. |
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