Carme Pidevall
Regulatory Affairs Specialist (Spain) at Almirall- Claim this Profile
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Bio
Marta Sala i Prat
Carme is a great professional, always looking for the success of the project she is involved in; she is constantly trying to get the best results. It was a nice experience working together in CMC Regulatory in Almirall. Her expertise in regulatory procedures and her personal point of view were the key for succeed in many projects we managed together. It’s been a pleasure to share and learn from her a lot of regulatory experiences.
Marta Sala i Prat
Carme is a great professional, always looking for the success of the project she is involved in; she is constantly trying to get the best results. It was a nice experience working together in CMC Regulatory in Almirall. Her expertise in regulatory procedures and her personal point of view were the key for succeed in many projects we managed together. It’s been a pleasure to share and learn from her a lot of regulatory experiences.
Marta Sala i Prat
Carme is a great professional, always looking for the success of the project she is involved in; she is constantly trying to get the best results. It was a nice experience working together in CMC Regulatory in Almirall. Her expertise in regulatory procedures and her personal point of view were the key for succeed in many projects we managed together. It’s been a pleasure to share and learn from her a lot of regulatory experiences.
Marta Sala i Prat
Carme is a great professional, always looking for the success of the project she is involved in; she is constantly trying to get the best results. It was a nice experience working together in CMC Regulatory in Almirall. Her expertise in regulatory procedures and her personal point of view were the key for succeed in many projects we managed together. It’s been a pleasure to share and learn from her a lot of regulatory experiences.
Experience
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Almirall
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Spain
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Pharmaceutical Manufacturing
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700 & Above Employee
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Regulatory Affairs Specialist (Spain)
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Jun 2016 - Present
Responsable regulatorio del registro/ mantenimiento del portfolio esencialmente de medicamentos pero también entrando en complementos alimenticios/productos sanitarios y cosméticos de la compañía que se comercializan en España, ya sean de desarrollo interno como resultado de acuerdos entre licencias. Responsable regulatorio del registro/ mantenimiento del portfolio esencialmente de medicamentos pero también entrando en complementos alimenticios/productos sanitarios y cosméticos de la compañía que se comercializan en España, ya sean de desarrollo interno como resultado de acuerdos entre licencias.
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PharmaNet/i3 Strategic Resourcing
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Regulatory Affairs Specialist
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Feb 2010 - May 2016
Regulatory activities in the Spanish market company (Almirall) for the maintenance and development of new products in the market, specially medicinal products (variations, renewals, line extension, pharmacovigilance and medical activities support and quality support to the regulatory industrial group, as well as revision and approval of the mockups for variations and artworks.) Key contact person with licensors and active member in project teams.
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Monitora de estudios observacionales (fase IV)
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Feb 2009 - Jan 2010
Coordinadora y técnico (CRA) para la gestión en las siguientes actividades a nivel de 3 grandes estudios observacionales nacionales: preparación de archivo y actividades de pre-selección de centros, submission a comités éticos y autoridades, visitas de inicio, monitorización y cierre, control de la medicación del estudio, revisión de CRFs y gestión de queries.Función de vínculo entre otros CRAs, investigadores y el promotor.
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Técnico de Farmacovigilancia
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Jul 2008 - Feb 2009
Recepción, entrada de datos y envío electrónico de casos (informes CIOMS) a partners y autoridades, custodia de las base de datos, revisión y formación de las filiales en materia de farmacovigilancia, revisión de casos en la literatura, preparación de PSURs y redacción de SOPs.
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TFS HealthScience
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Sweden
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Pharmaceutical Manufacturing
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300 - 400 Employee
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CRA (Monitora de Ensayos Clínicos)
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Oct 2002 - Jul 2008
Presentación a CEICs y autoridades, gestión de firmas de contratos, revisión de protocolo, CRD, visitas de pre-estudio, start-up visits, visitas de monitorización, pagos a los investigadores, elaboración y seguimiento de queries, control de la medicación del estudio, visitas al servicio de farmacia, cierre de los centros, cierre del estudio. He participado en todas las fases de un ensayo clínico en las áreas de Oncología (en Almirall y en Sanofi-Aventis), Dermatología (en Laboratorios Salvat) y SNC (parkinson y Altzeimer, en Novartis). Show less
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Education
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2002 - 2002
ESAME
Master en monitorización de Ensayos Clínicos, Clinical trials -
2001 - 2001
Universidad Autónoma de Bellaterra
Proyecto de investigación básica del doctorado en Medicina Interna -
1993 - 1998
Universidad de Barcelona
Licenciatura en Farmacia
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