Aziza Bouabdallah

Support worldwide registration activities : registration file responsible in APAC region (Australia, New Zealand)and EMEA region[Europe, Middle East, Maghreb, Africa,Australia]) License intelligence :assess and monitor worldwide registration licences (contact with regulatory agencies for the requests) and planification Review technical and scientific data for incorporation into submission to the EU (CE mark, FDA etReview and evaluate technical and scientific data for incorporation into submission

Mission : Put in place of a guidelines concerning the improvement of a clinical database -Put in place of a nomenclature to improve the identification of the regulatory clinical documents present in the database -Quality control of the conformity of documents registered final version, identificati

Mission: Data processing relative to clinical studys - Analyze differences between ECG / patient form (inclusion, establishment, follow-up visits, end form)- work on time switch - Sent to the statistical treatment center (CRO) of the data forms of the study - Management of queries generated by th

Mission : Set up and follow up of the quality system Quality management : Updated the quality system , the registers, the internal audits, and the renew of the ISO9001 : 2000 -Treated the quality no conformities of the 6 business unit : pharmacy, cosmetics, food, north industry, south industry,

Mission : Development of a new line of special breads -Analysis of the market before the launch of the product -Development of the product : participation at promotional operations at Sainsbury’s -Organisation of organoleptic tests -Organisation of formulation tests on samples at the laboratory

Mission : Establishment of the quality system within the ISO 9001 : 2000 Quality management : - Organised customers audits / Internal audits / suppliers audits : checked of the differences with the standards , corrected the differences, and wrote audit reports - Revised and wrote internal qualit

health law specialization in regulatory affairs

REGULATORY AFFAIRS