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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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Industry Events |
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4th Annual Patient Recruitment and Retention in Clinical Trials
13-15 October 2008, Amsterdam
Patient recruitment
is now consuming thirty percent of clinical trial time - more time than any
other clinical trial activity - and almost half of all trial delays result from
patient recruitment problems.
As the
recruiting culture becomes more sophisticated and the forces affecting patient
enrollment grow more numerous and complex, pharmaceutical companies are
striving to discover new strategies to facilitate enrollment in clinical
trials.
With
increasing industry pressure to develop, test and market greater numbers of new
drugs faster, pharmaceutical companies need to perform clinical trials as
quickly as possible. Inefficient patient recruitment processes is a formidable
barrier to pharmaceutical companies' success in launching new products.
Improving the patient recruitment process is imperative to avoid wasted
investments and eliminate costly delays in bringing new drugs to market --
today and even more so in the not-so-distant future. Improved patient
recruitment presents one of the largest opportunities for pharmaceutical
companies to eliminate delays in clinical trials, thereby making it possible to
reduce time to market. With patent time limits and large overheads
meaning that any delays in the development timeline can be disastrous, a good
understanding of how to successfully recruit patients for trials is vital for
any company looking to succeed.
More info >> |
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News and Press Releases |
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MipTec, October 14 – 16, 2008, Switzerland
MipTec about to take off by joining forces between Life Sciences Week, ALL-SystemsX.ch-Day, & Jobvector.com
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