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Terms of Use - SKILLPHARMA
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The access and use of this website is subject to the following terms and conditions and all the applicable laws. By accessing and using this website, the user accepts the following terms and conditions, without limitation or qualification. Unless otherwise stated, the contents of this website, including the text and the images, belong to SKILLPHARMA Srl. All the trademarks used belong to their respective owners. SKILLPHARMA Srl does not accept ideas, projects or information outside of defined and signed ...
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Institutional Affairs - SKILLPHARMA
http://www.skillpharma.com/en-institutional.html
The proper management of the communication with the regulatory authorities and agencies is crucial to achieve companies business goals. Thanks to an extremely deep knowledge of the political and institutional scenario where pharmaceutical companies have to deal with, SKILLPHARMA is the ideal Partner to develop together with its Customers the appropriate relationships with all the health sector stakeholders. Thanks to its skills, SKILLPHARMA provides to. Via Umberto Saba 4, 00144 Roma.
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Home - SKILLPHARMA
http://www.skillpharma.com/it-index.html
SKILLPHARMA consente ai propri Clienti il raggiungimento dei loro obiettivi gestendo le attività strategiche e le fasi operative per l'intero lifecycle dei prodotti. SKILLPHARMA è il Partner ideale per la gestione efficiente ed efficace dei Sistemi di Vigilanza dei propri Clienti, sia in caso di completo outsourcing delle attività che per specifici processi connessi ad esigenze post-marketing. Via Umberto Saba 4, 00144 Roma. Numero REA RM 1100260. Capitale sociale € 10.000,00 i.v.
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Scientific Consulting - SKILLPHARMA
http://www.skillpharma.com/en-scientific.html
Medical and scientific advice is a crucial element of the strategic and operational activities for the health sector companies, as the production, assessment and management of data and clinical information distinguish the whole lifecycle of medicinal and para-pharmaceutical products. Qualified Person on the role Scientific Service Responsible in according to legal requirements. Development of informative materials for internal consultation, training for staff and sales representatives. Congresses, confer...
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Post Marketing Vigilance - SKILLPHARMA
http://www.skillpharma.com/en-postmarketing.html
Each health sector company must guarantee the safety of its products on the market and have effective vigilance systems monitoring the safety of medicinal products and early detecting any change to their risk-benefit ratio for the population. ICSR assessment, triage and processing, as well as follow-up requests (RNF and Eudravigilance). Weekly worldwide and local literature search and review. Development and management of the Pharmacovigilance System Master File (PSMF) by using a dedicated software.
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Home - SKILLPHARMA
http://www.skillpharma.com/en-index.html
SKILLPHARMA let its Customers to achieve their business goals managing the strategic activities and all the operational steps relating the whole products lifecycle. SKILLPHARMA is the ideal Partner for the effective management of its Customers Post Marketing Vigilance Systems, as if they need the complete outsourcing of the activities, as for specific processes related to post marketing requirements. Via Umberto Saba 4, 00144 Roma. Numero REA RM 1100260. Capitale sociale € 10.000,00 i.v.
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About Us - SKILLPHARMA
http://www.skillpharma.com/en-chisiamo.html
SKILLPHARMA derives from a simple and functional intuition: a unique entity which combines competences and abilities belonging both to pharmaceutical industry and public administration. The fusion of these different cultural and organizational experiences has given life to an extremely effective mix, allowing SKILLPHARMA to offer a distinctive added value on the pharmaceutical market. In order to clearly define the responsibilities to the different internal or external stakeholders, SKILLPHARMA approved ...
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Mission - SKILLPHARMA
http://www.skillpharma.com/en-mission.html
We aim for technical and management excellence, to create solid value and competitive advantage. We offer concrete and usable solutions, thanks to our highly qualified and reliable staff, people working where merit, respect and team play matter. We want to give development opportunities, combining professional procedures and operating system and through a collaboration stable and accurate, that preserves the solidity and reputation of all our Partners. Via Umberto Saba 4, 00144 Roma. Numero REA RM 1100260.
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Regulatory Affairs - SKILLPHARMA
http://www.skillpharma.com/en-regulatory.html
The proper management of the regulatory activities is crucial to achieve the business goals of the health sector companies. Thanks to its long-standing multidisciplinary experience, SKILLPHARMA supports effectively its Customers in obtaining and maintaining all the necessary authorizations for marketing their pharmaceutical products, minimizing the times required. Preparation and submission of MA variation applications (type IA/IB, type II, Line extension), MAH ownership transfers and MA renewals. Prepar...