The EU Directive 2010/84/EU introduced a new format of organization of pharmacovigilance processes, the Pharmacovigilance System Master File (PSMF).This training will offer its participants practical knowledge on how to transition to PSMF, onferencecKEY TOPICS    Change management of system – how to do it in a timely and efficient manner?    Deconstructing GVP Module IIOUR PROMINENT TRAINERShelley Gandhi is a renomrwned pharmacovigilance expert. Currently leading the Pharmacovigilance and Drug Safety team at NDA Group, Europe's leading regulatory drug development, pharmacovigilance and HTA consultancy, she has over 20 years of experience in this area. Read more about the trainerWHAT MAKES THE TRAINING UNIQUE    FOCUS: How to maintain a PSMF and how to prepare for inspections. PSMF is a base for all pharmacovigilance activities.    TRAINER: Shelley Gandhi is one of the most respected experts in the industry. She held various senior-level positions at the Medicines and Healthcare products Regulatory Agency (MHRA).   leaf icon Pharmacovigilance Training 2014    EXPERIENCE: We have four years of running one of the most successful pharmacovigilance events in Europe.    LOCATION: Germany is one of the biggest pharmaceutical markets. Frankfurt makes the training easily accessible for most European pharma representatives.    FORMAT: Conducted in a targeted small environment, there is much time for discussion. Excercisebased approach and debate over the best practices is in the core of the format.    DEPTH: It offers over 12 hours of in-depth study of the subjects