PPT-Global Regulatory Affairs

US vs EU Nariko Koto MBA Global RegulatoryBusiness Consultants LLC January 13 2014 For French Chamber of Commerce Nariko Koto Bio 15 years experience in the medical device biologics and pharmaceutical industries. AMPLIFY™ Matrix – Panel PresentationMeeting objectives:• Present scientific data supporting safety, effectiveness & positive benefit:risk ratio • Provide additional data & perspect Regulatory Affairs Professional Development Framework: An Overview . GMP- A Regulatory Perspective. Regulatory Perspective in entering . Global . Pharma. Markets. Regulatory Perspective in entering . Global . Pharma. Markets. World wide market of . pharma. products:. American and Caribbean Sea Hydrographic Commission (MACHc16). the Cruise Industry Perspective. Kim Hall. Cruise Lines International Association. Director, . Technical and Regulatory Affairs . Operational & Security. WHO Technical Briefing Seminar on Essential Medicines and Health Products. 31 October 2013. WHO Headquarters, Geneva, Salle M 505. Dr Claudia P Alfonso . Outline. Global overview of vaccine production and immunization . Update on the WHO NRA Global Benchmarking Tool. HIS/EMP/RHT/RSS. Outline. Between the 1. st. and the 2. nd. International Consultations. Discussions of the 2. nd. International Consultation. Outcomes and next . Global Curriculum Project. Ensuring Safe Food and Medical Products Through Stronger Regulatory Systems Abroad. 2012 Institute . of Medicine Report. Product . safety through . GMPs, GAPS. Staff . development and training . & Annual Meeting. June 13, 2017. An Overview of the Biotechnology Innovation Organization. Patrick Plues. Vice President, . State Government Affairs. BIO. BIO Fact Sheet. Founded . 1993. Tax. Status. March 12, 2014. International Insurance Regulatory Issues. 10th . Annual Insurance Public Policy Summit. “Confronting . New Challenges in U.S. and International . Regulation”. . List of Current IIF Insurance Members. WHO Technical Briefing Seminar on Essential Medicines and Health Products. 31 October 2013. WHO Headquarters, Geneva, Salle M 505. Dr Claudia P Alfonso . Outline. Global overview of vaccine production and immunization . kindly visit us at www.examsdump.com. Prepare your certification exams with real time Certification Questions & Answers verified by experienced professionals! We make your certification journey easier as we provide you learning materials to help you to pass your exams from the first try. Professionally researched by Certified Trainers,our preparation materials contribute to industryshighest-99.6% pass rate among our customers. kindly visit us at www.examsdump.com. Prepare your certification exams with real time Certification Questions & Answers verified by experienced professionals! We make your certification journey easier as we provide you learning materials to help you to pass your exams from the first try. Professionally researched by Certified Trainers,our preparation materials contribute to industryshighest-99.6% pass rate among our customers. Expectations from European industry . regarding . collaboration on drug quality and environment. A Global industry acts with global standards. 2. Excellence Builds on Continual Improvement. 3. EFPIA . ACSDA General . Assembly. Santiago de Chile. April. 2014. The origins of the Crisis…. 2006 : Mortgage defaults in the US subprime mortgage market. Global economy contaminated through securitisation.