Samantha AKAKPO

En résumé

Entreprises

• Medicines for Malaria Venture - Genève - Safety officer

  2015 - maintenant

• French Health Safety Products Agency - Drug Safety Assessor

  2012 - maintenant * Drug Safety Assessor in Oncology, Hematology Department:
  - In charge of assessing adverse drug reactions in spontaneous case reports (Routine
  Pharmacovigilance) in Clinical Trials.
  - In charge of assessing periodic safety reports (PSURs) from companies and of
  writing Safety reports, as well as contributing to Safety Working Groups.
  - Liaising with the European medicines Agency (EMA) and the Food and Drug
  Administration (US-FDA).
  * Non-clinical Assessor of Drugs, Therapeutic Medical Devices and Cosmetic Products:
  - In charge of assessing pharmaceutical/cosmetic products and medical devices,
  writing Safety reports.
  - Liaising with the European Commission (Representation of the Agency in Working
  Groups in the EC).

• Genentech - Safety co-op

  San Francisco 2011 - maintenant Contribute to Safety assessment of Genentech therapeutics :
  - Analysis/Presentation of toxicology data, toxicology program design for new drugs in development
  - Preparation of study reports/manuscripts,
  - Participation in cross-functional initiatives/collaborations
  - Application of regulatory guidance to toxicology program design , especially for ocular drug development

• Association des Compétences - Volunteer

  2011 - maintenant ASCOVIME: Association des Compétences pour une Vie Meilleure
  (Association for Health and Education in Cameroon): In charge of implementing a
  ``patient diary'' with essential medicines.
  Member of the Human Rights Association in for H2H (Hôpital des 2 Hémisphères): Association providing classes, drugs,
  medical material to hospitals in Togo: In charge of collecting funds.
  Volunteer for MdM ( Medecins du Monde) : Chromatography and Drugs analysis.

• US-FDA - Intern

  2010 - 2010 1) DAVP (Division of Antiviral Products), Pharm/Tox team :
  - Learned the different steps of the drugs evaluation before their Marketing Authorization, different existing submissions : IND, NDA.
  - Learned the Points to Consider when reviewing the case studies.
  - Attended different meetings : Safety meetings, Regulatory briefing meetings, Advisory Committees, internal meetings, Sponsor meetings.
  - Worked on a database in order to identify recent published literature reporting effects of antiviral treatment on influenza virus shedding and symptoms.
  - Reviewed studies for influenza antiviral products.
  
  2) Drug Shortage team :
  - Knowledge of the reasons for Shortages, actions taken as part of shortage management.
  - Learned the MaPP 6003.1 Drug Shortage Management.
  - Participating in different drug shortage projects by contacting different companies, requesting information on the status of certain drugs (familiar with the Orange book, Red book) and contacting patients.
  - Attended internal meetings , meetings with different companies (audioconference).
  - Helped in translating reports ( french to english) issued by the French Health Safety Products Agency.

• Huma Pharma Association - Student

  2007 - 2009 organized humanitarian association in which I was
  in charge of helping homeless people.
  
  Music: Play the guitar
  Sport: Capoeira, Classic and Modern dance

Formations

• Faculté De Pharmacie/Université René Descartes (Paris)

  Paris 2005 - 2011

Réseau

• Audrey LALLART

• Camille BOSSARD

• Daniel BOUCHARD

• Fanny HAKAMI

• Huet CHARLES

• Jean-Gilles BERTRAND

• Jonathan BOCOBZA

• Marta GERSBERG

• Nicolas GOTZ

• Stephane CAILMAIL