Annie Ramahatra Email & Phone Number

Bois - Colombes (France)

 Teaching PSE Prevention - Health – Environment, to classes preparing the Professional Bachelor (2nd, 1st and Terminals) and students preparing for the Certificate of Professional Training Monitoring students during their Period of Training Professional) Supervising students during visit to exhibition of Admission Post Baccalaureate

Cergy (France)

 Organizing her life’s framework  Provisioning Managing and checking daily personnel Having relationship with medical personnel Following expenses and doing reports to the legal department since she was put in the care of a guardian

Set up Good Laboratory Practice (according to OECD) in the Physiology laboratory (for the tests) of the Non Clinical Safety Unit. My Achievements :➢ Audit of the system compared to the reference frame GLP➢ Establishment of an assessment quality of the NCSU including/understanding: identification of the points to be improved (variations), measurements corrective to undertake, and the annual planning of realization of the task➢ Drafting the procedure of general organization of the NCSU, by processes cartography, in accordance with the applicable reference frames (Handbook quality of the LFB and Standards ISO 9001: 2000) ➢ Contribution to the development and the improvement of the quality system by sensitizing teams to quality and the good practices➢ Drafting "FILE GLP relating to the inventory of fixtures of the test sites subjected to the principles of GOOD LABORATORY PRACTICE (GLP)" in the frame file document of the regulatory authorities

Within the CHAMBRE DE COMMERCE ET D’INDUSTRIE at Cité des formations professionnelles (CIFOP)- Angoulême2006 /2007 TRAINER: Within the framework of the Professional Patent of Pharmacist, teaching by using pedagogy by operational objective, to build the stages necessary to the acquisition of competences: ➢ To the apprentices in alternation: teaching botany and phytotherapy➢ To trainees in continuous training: teaching the matters which go from the plant to the drug: botany, phytotherapy, chemistry, biochemistry, pharmacognosy, homeopathy

bringing thanks to my pragmatic experiment, the point of view of an expert in pharmaceutical industry. My contribution:➢ Working out and writing the pilot process production of Factor IX (Laboratory of Fractionation and Biotechnologies - LFB- Lille, project coagulating fractions section) ➢ Making a documentation review for drafting a master line qualification (DPE - GlaxoSmithkline factories)➢ Contributing to setting up a method of scale-up transpositions for the STP congress of Montpellier (may- June 2002)➢ Validating by my pragmatic approach a theorical logogram of activities transfer (distribution of clinical batches for Aventis Pasteur Lyon).

ensuring the permanence of the factory at the lawful level with respect to the authorities and of the customers, through a project control of handing-over to the standards of the site. In this framework, my achievements: Internal audits  Drafting processes validations (BIOGARAN , GALENIX, SERP, JOHNSON & JOHNSON, MERCK GÉNÉRIQUES, LAPHAL, CS DERMATOLOGIE) and equipment production retrospective qualifications - Drafting General procedures in quality assurance (through revision), SOPs, Quality Handbook Production and Validation Master Plan- Drafting files (version 0 to x) on the project of renewing buildings, laying out work areas, focusing on adequate air conditioned, validation production process, cleaning and qualifying materials - Drafting IQ OQ PQ protocols for equipments retrospective validation - Standard protocol for validation products - Drafting technical file for a type II variation to a Marketing authorisation : FOURNIER- Setting up cleaning validation - Personal training scheme developed according to GMP ➢ External audits - Customers ‘audits : SMITHKLINE –BEECHAM, EXPANPHARM, SERP, UPSA- Audit corporate PFIZER- Suppliers’ audit⇒RE-OBTENTION of GMP CERTIFICATE

Teaching of Chemistry to undergraduate and graduate students, Research on medicinal plants➢ Scientific publications on the medicinal plants.⇒From 1986 collaboration with Laboratories OFAFA, while preserving teaching at the University

At the drugs factory Ofafa in Antananarivo Madagascar (150 people) 1995/1998 PRODUCTION MANAGER: Reorganizing management by setting up a new organization chart➢ Drafting and setting up a Quality handbook an new flow chart➢ Development of the training scheme according to the GMP of the personnel.➢ Productivity improvement: increase by 28%

Setting up a highly efficient organizationDetails on the mission:• Organization of the department in 2 distinct sections: physicochemistry and microbiology• Setting up a system of daily checking drugs production according to GMP and checking essential oils production according to AFNOR and ISO• Analytical control of syrups manufactured in subcontracting for SANOFI AVENTIS for local market (release of the batches being done in France)• Decrease non suitable products by 0.5% to 0.08%

setting up the department R & D and installing the department extraction of the aromatic and medicinal plants➢ Number of drugs developed: Tablets: 50. Syrups: 11. External use products: 7➢ Analytical development➢ Industrial development: validations of formulations by pilots for industrial transposition and link between laboratory development and production area.➢ Drafting chemical and pharmaceutical documentation (part II).➢ Subcontracting essential oils extraction – essential oils intended for exportation

Phd, Organic Chemistry

Thesis - with Professor André CAVE - on medicinal plants : ": contribution à l’étude des annonacées : alcaloïdes de Polyalthia suaveolens.

Organic Chemistry

Chemistry

Pharmacognosy