Differences in Pharmacovigilance Regulatory Requirements in Latin America countries (LATAM): impact in the real world experience (2464)

Objective: 1)To carry out an update of the data of the control agencies in LATAM ;to evaluate the real state of PVG programs about safety of biological/ follow-on drugs and synthetic products;2)to describe different Risk Evaluation Mitigation Strategies (REMS);reporting process in LA;3)to communicate relevant safety information from all available data sources in our population ;4)to recommend appropriate regulatory actions that may impact in daily clinical practice and to describe strategies and actions to minimize risk. Background: Pharmacovigilance (PVG) according to WHO is the science/activities relating to the detection, assessment, understanding and prevention of adverse effects (AEs) or other drug-related problems. An increase in the real-world incidence of PML/other AEs is concerning. Design/Methods: The LATAM MS Forum is an independent group of 14 experts has assessed latest scientific evidence regarding efficacy and safety of treatments in MS in LA. Currently 12 countries are members: ARG, Bolivia, Brazil, Chile, Colombia, Costa Rica, Ecuador, Mexico, Panama, Peru, Uruguay, Venezuela. PVG was the main topic of this working group focused on differences between countries including typical infections/different diseases. Results: 1)LA has its own regulatory agency based on FDA and EU Agency regulations and different regulations at the time to approve biosimilar, follow-on drugs or copies of oral drugs. Actually in some countries we have approved between 1–10 different copies of some drug 2)The reporting program depends of medical/ pharmaceutical/patient reports. Unfortunately n of reports from doctors are rare 3)doctor’reports are infrequent among LA countries 4)PVG education is rare in LA that impact in adherence/compliance. Conclusions: PVG database with information on drugs safety and efficacy is a needs and the aim objective should include the long-term data information. We conclude that:1)to develop PVG network in LA with prevention/mitigation strategies like continuous medical education and patient counseling to be effective in tackling AEs;2)promote adherence to treatment with various measures to manage adverse events and promote adequate compliance; )some topics should be considered include in ours REMS. Disclosure: Dr. Steinberg has nothing to disclose. Dr. Carra has nothing to disclose. Dr. Fragoso has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with received honoraria as a consultant on scientific advisory boards by Novartis, Teva, Roche and Sanofi-Aventis and compensation for travel from Novartis, Biogen, Sanofi Aventis, Teva, Roche and Merck.. Dr. Macias-Islas has nothing to disclose. Dr. Carcamo Rodriguez has nothing to disclose. Dr. Ciampi has nothing to disclose. Dr. Correa Diaz has nothing to disclose. Dr. Duran Quiroz has nothing to disclose. Dr. Garcia has nothing to disclose. Dr. Guerra has nothing to disclose. Dr. Novarro has nothing to disclose. Dr. Oehninger has nothing to disclose. Dr. Orozco has nothing to disclose. Dr. Rodriguez has nothing to disclose. Dr. Trevino Frenk has nothing to disclose. Dr. Vizcarra has nothing to disclose.