PPT-Orphan Drug Global Incentives & Regulatory Framework

Author : pasty-toler | Published Date : 2018-11-21

Marlene E Haffner MD MPH CEO Haffner Associates LLC Orphan Drugs Summit 2012 Thursday 27 th September 2012 Current Pharma Trends Slow pharma industry growth Patent

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Orphan Drug Global Incentives & Regulatory Framework: Transcript

Marlene E Haffner MD MPH CEO Haffner Associates LLC Orphan Drugs Summit 2012 Thursday 27 th September 2012 Current Pharma Trends Slow pharma industry growth Patent expiration. A new proposal to foster greater orphan drug development. 1. The OPEN ACT. O. rphan. . P. roduct. . E. xtensions. . N. ow. A. ccelerating. . C. ures. . &. . T. reatments. www.CureTheProcess.org. FDA and Regulatory Environment As We Enter the User Fee Reauthorization Period. Mike Druckman, Partner, Hogan . Lovells. Mike Druckman. November 2016. FDA Update: Regulatory . Environment . and PDUFA Reauthorization . Unfinished Business. Asli. . Demirguc-Kunt. The World . Bank. March 27, 2012; Columbia Univ.. Causes of the Crisis… . Macro . policy and global imbalances made the crisis more . likely…. …. . May 13, 2009. Keys to Future Stability and Growth: Institutional Investors and Regulation. Outline. Some basic concepts/lessons from the current crisis. Traditional roles of institutional investors and asset managers. Carolyn Compton, M.D., Ph.D.,. CEO and . President. Critical Path Institute . (. C-Path). IOM Workshop International Regulatory Harmonization. Washington, DC. February 13, 2013. The Global Challenge. Regulatory Control Training Workshop. Regulatory Cooperation Forum. Peter Hughes. 6-10 November, 2017. Morocco. Learning Objectives. After going through this presentation the participants are expected to be familiar with:. 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 . Investigational New Drug Application (IND); Summary of regulations and guidelines . Introduction of . cGMP's. /principles of validation . Introduction to QA/QC principles . Good Laboratory Practice (GLP) compliance . The Case Against Global Standardization. Katharina Pistor. Columbia Law School. Outline. Points of departure. The Structure of Financial Markets. Implications for Regulating Global Finance. The Case for Flexible Coordination of Regulatory Diversity. 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 . Carolyn Compton, M.D., Ph.D.,. CEO and . President. Critical Path Institute . (. C-Path). IOM Workshop International Regulatory Harmonization. Washington, DC. February 13, 2013. The Global Challenge. 2.4 - Understand the legal and regulatory framework governing the storage and use of global information Cambridge TECHNICALS LEVEL 3 2016 RELATED ACTIVITIES e This unit Title of suggested activity Balancing Gold Standard Evidence with Patient-Centered Flexibility. Sarah L. Wicks, JD, MPH. University of Minnesota – Rare Disease Day 2020. February 28, 2020. 1. Overview. FDA’s “Gold Standard” for Approval. 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 .

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