Header
Ihr Suchergebnis
Sie recherchieren derzeit unangemeldet.Melden Sie sich an (Login) um den vollen Funktionsumfang der Datenbank nutzen zu können.
Sie suchen in allen Bereichen nach dem Autor Schoepke O.
In der Rubrik Zeitschriften haben wir 2 Beiträge für Sie gefunden
-
MerkenThe ‘Single Point of Truth’: Effective Regulatory Information Management
Rubrik: Fachthemen
(Treffer aus pharmind, Nr. 07, Seite 1008 (2015))
The ‘Single Point of Truth’: Effective Regulatory Information Management / For Small and Medium-sized Enterprises facing ISO IDMP · Schoepke O · Samarind Ltd., Deeside und Flintshire, UK
Compared to large pharmaceutical corporations, small and medium-sized enterprises (SME) face different challenges in today’s regulated healthcare market. And the introduction of ISO Identification of Medicinal Products (IDMP) [ 1 ] is no exception. Smaller product portfolios, extensive competition and harsh timelines all play a role in the challenge of making enough profits to benefit all parties concerned, from the drug originator via the healthcare professional to the patients. With the forthcoming implementation of ISO IDMP in Europe in 2016, the pressure only intensifies. Following on from Article 57(2) of Regulation (EU) No 1235/2010 (EVMPD), ISO IDMP will introduce new requirements for marketing ...
-
MerkenThe Medicinal Product Registration Format
Rubrik: Fachthemen
(Treffer aus pharmind, Nr. 07, Seite 1026 (2014))
The Medicinal Product Registration Format / From Paper via NeeS and eCTD to Regulated Product Submission (RPS) · Neurauter G, Schoepke O · 1EXTEDO GmbH, Ottobrunn, Germany und 2Samarind Ltd., Deeside, Flintshire, UK
The regulatory submission process went through tremendous changes over the last few years, moving away from pure paper submissions into the information technology world. Applicants as well as agencies are able to benefit from electronic documents and meta data, streamlining the submission process. Following several national initiatives in the late 90's, the ICH (International Conference on Harmonisation) established a submission format – well known as eCTD (electronic Common Technical Document) – covering the ICH regions of Europe, US and Japan. The same standard now builds the foundation of electronic submissions in a number of countries outside the ICH region, with ...
