Nota de prensa FARMAFORUM 2019

A continuación os facilitamos la nota de nota de prensa sobre “María Jesús Lamas, directora de la Agencia Española de Medicamentos, inaugurará FARMAFORUM 2019”.

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3rd European QA Conference

A continuación os facilitamos el enlace a la información de la  3rd European QA Conference que se celebrará en Dublín del 6 al 8 de noviembre de 2019.

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Invitación Farmaforum 2019

Farmaforum 2019, Foro de la Industria Farmacéutica, Biofarmacéutica y Tecnologías de Laboratorio celebra su sexta edición en Madrid. De nuevo se han elegido las instalaciones de IFEMA, concretamente el pabellón 8 de la Feria de Madrid. En sus seis años de existencia, Farmaforum ha logrado consolidarse como el evento más importante de la Industria Farmacéutica en España, extendiendo […]

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EMA communication: Regulatory Science to 2025 – strategy for a six-month public consultation

EMA has published its draft ‘Regulatory Science to 2025’ strategy for a six-month public consultation. This is a proposed plan for advancing the Agency’s engagement with regulatory science over the next five to ten years, covering both human and veterinary medicines. The strategy will help shape the vision for the next EU Medicines Agencies Network […]

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EMA Communication: Draft veterinary consultations

The European Medicines Agency has published the following reflection papers for consultation: Draft guideline for the demonstration of efficacy for veterinary medicinal products containing anticoccidial substances – Deadline 31 August 2019 Draft guideline on requirements for the quality (production and control), safety and efficacy of allergen products for use in horses, dogs and cats – […]

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RQA – GLP Refresher Course

The course is aimed at providing a reminder and refresh insight of the key GLP requirements and responsibilities and also to look at recent hot topics and trends. Specific areas covered include Data Integrity, Risk Assessment and the new OECD guidance on Test items. The programme also includes a GLP clinic where delegates can identify […]

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EMA Consultation: Discussion paper: Use of patient disease registries for regulatory purposes – methodological and operational considerations

The European Medicines Agency has released for public consultation a discussion paper on the use of patient disease registries for regulatory purposes – methodological and operational considerations. This discussion paper has been prepared by the Cross-Committee Task Force on Registries established by the EMA Patient Registries Initiative. The main objective of this initiative is to […]

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EMA Consultation: Draft guideline on the quality of water for pharmaceutical use

The European Medicines Agency has released for public consultation a draft guideline on the quality of water for pharmaceutical use. Water is one of the major commodities used by the pharmaceutical industry. It may be present as an excipient or used for reconstitution of products, during synthesis, during production of the finished product or as […]

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