Pharmacovigilance in Middle East Conference
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1 Pharmacovigilance in Middle East Conference Target Audience: January, 2012 Yas Rotana Hotel Abu Dhabi UAE HAAD Accredited for 7.25 CME Hours Regulatory Authorities; (Safety Programs, Regulatory affairs) Pharmacovigilance Solution/Systems/Technology Providers. Risk Management Consultants. Pharmaceutical Companies, CROs and Consultancy Firms ( Drug safety, Regulatory affairs, Medical affairs, Quality assurance, Safety process, Post-marketing surveillance, Signal detection, Patient safety, Data management, R&D) personnel for: (Pharmacovigilance, Medical monitoring, Drug safety project manager, Safety and risk management, Community Pharmacists, Clinical Pharmacists, Physicians) 1 st Day of the Conference; 20th January, :30am - 8:30am 8:30am - 9:00am Registration HAAD Opening Remarks Dr.Mohammed Abuelkhair Head, Drug and Medical Product Regulation Section Health Authority-Abu Dhabi 9:00am - 9:30am Federal Pharmacovigilance Committee Speech Pharmacovigilance System in UAE. Dr.Amin Alameeri Asst.Undersecretary for Medical Practice and License (CEO) Ministry of Health, UAE
2 9:30am 10:00am Current Practice of PV in Abu Dhabi. Dr.Mohammed Abuelkhair Head, Drug and Medical Product Regulation Section Health Authority-Abu Dhabi 10:00am -10:30am 10:30am -11:00am Spontaneous reporting: Saudi Arabia Experience Expedited Reporting: Regulatory Perspective Definitions: ADEs, Serious events, unexpected events and serious Unexpected events. Backbone structure of ICSRs New Pharmacovigilance legislations Dr.Nasser AlQahtani Head, ADRs Evaluation Division Saudi Food and Drug Authority (SFDA) 11:00am -11:30am 11:30am -12:00 pm Break Periodic Safety Update Reports (PSUR) What is a PSUR Regulatory requirements for PSURs (International and in MENA) Differences in PSURs for Originators Vs Generics How to prepare a PSUR Dr.Lubna Rshaidat Regulatory Affairs Department Head Tabuk Pharmaceuticals-Jordan 12:00pm-01:45pm 01:45pm-02:30pm Friday Prayer & Lunch Risk management plans in PV To differentiate between risk management plans and risk minimization plans To outline the structure of RMP To have a background about the international requirements Dr.Adel Alrwisan Vigilance and Crisis Mangement Executetive Directorate Saudi FDA
3 02:30pm-03:15pm Global Networking in Pharmacovigilance. Progress in the PV scope Global system in PV Signal detection Dr.Amr Saad Head of the Egyptian pharmacovigilance Center EPVC 03:15pm-04:00pm Information Technology Systems in Pharmacovigilance. Mr.Subbaraju Sagi Managing Director Life & Health Sciences, TechSol & Robbert P. van Manen, M.Sc. Master Principal Sales Consultant Oracle Health Sciences 04:00pm-05:20pm Reporting Pharmacovigilance Profiles of different Medications (Workshop) Approved REMS plan for (Sitagliptin/metformin) Combination Bernd Voss Regional Director of Medical Affairs for Diabetes (Eastern Europe, Middle East, Africa) MSD RBSC in Munich, Germany 05:20pm-05:30pm Closing Remarks. End of the first day of the conference
4 2nd Day of the Conference; 21st January, :00am-08:15am 08:15am-09:00am Opening the Second Day of the conference Training plans for PV Personnel Who can be a QPPV. What are the responsibilities of a QPPV. International Qualifying Training Courses. Dr.Mohammed Saleem Managing Director of SIPS SIPs, Jordan 09:00am-09:40am Medication Errors Reporting Define and categorize a medication error Report medication errors Investigate medication errors Dr.Adeline Saliba Acting Pharmacy Manager/Medication Safety Manager Al corniche Hospital 09:40am-10:00am Assessing your medication management system Benefits of assessing Recommended tools to assess your medication management system Developing action plans relevant to your assessment and defining priorities Dr.Lana Hammad Head of Pharmacy Department Al Rahba Hospital 10:00am-11:20am Reporting Pharmacovigilance Profiles of different Medications (Workshop) Romiplostim - Modified Nplate REMS program Dr. Tamer Saad Medical Director Amgen MEA Efficacy and safety of Dusasteride on management of benign prostatic hyperplasia
5 Dr. Essam Fikry Senior Medical Affairs Manager for Oncology and Urology GSK 11:20am-11:50am 11:50pm-01:50pm Break Developing Key Performance Indicators (Workshop) Should Key Performance Indicators for Clinical Services Be Mandatory Describe how to identify and select Key Performance Indicators (KPIs) that align with organizational needs Identifying your targets Define challenges in meeting your target Dr.Lana Hammad Head of Pharmacy Department Al Rahba Hospital 01:50pm-02:00pm Closing Remarks. Lunch End of the Second Day of the Conference
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