PPT-Regulatory Issues Introduction to the Regulatory Approval Process; Overview of the FDA

Author : liane-varnes | Published Date : 2018-12-12

Investigational New Drug Application IND Summary of regulations and guidelines Introduction of cGMPs principles of validation Introduction to QAQC principles

Presentation Embed Code

Download Presentation

Download Presentation The PPT/PDF document "Regulatory Issues Introduction to the Re..." is the property of its rightful owner. Permission is granted to download and print the materials on this website for personal, non-commercial use only, and to display it on your personal computer provided you do not modify the materials and that you retain all copyright notices contained in the materials. By downloading content from our website, you accept the terms of this agreement.

Regulatory Issues Introduction to the Regulatory Approval Process; Overview of the FDA: Transcript

Investigational New Drug Application IND Summary of regulations and guidelines Introduction of cGMPs principles of validation Introduction to QAQC principles Good Laboratory Practice GLP compliance . The racing regulatory veterinarians reiterated their concern that the permissive nonsteroidal antiinflammatory NSAID policies in the United States are compromising the examining veterinarians ability to indentify horses at risk for catastrophic inju I. nternational . N. arrative. Dr. Malathy Knight. Research Associate, Verite Research. March 26. th. , 2015. RIA: “What” and “Why”. Unpacking the international narrative on RIA. RIA in developing countries: issues and challenges. Mark . Atalla. , . PharmD. Disclosure. I have no relevant financial relationships with commercial interests pertaining to the content presented in this program. Objectives. 3. Key Things to Walk Away With:. 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. Harmonization and . African Medicines Agency. Margareth Ndomondo-Sigonda. NEPAD . Planning and Coordinating Agency. Midrand, Johannesburg. South Africa. OUTLINE. Introduction to NEPAD. Background and Overview of the African . 1. 24. th. EPSO Conference. 26 September 2017. Adj Assoc Prof (Dr) Raymond Chua. Group Director (Health Regulation Group), Ministry of Health. Overview of Regulatory Landscape. 2. Ministry of Health (MOH). May 16, 2016. Practical Tools: RIA light and Public Consultation Basics. Regulatory Impact Analysis (RIA). A systematic policy tool used to examine and measure the likely benefits, costs and effects of regulations. 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. (i.e. no one has seen or approved this). Draft 07/01/13. Coordination. This is the point at which we need to truly start integrating the work products of the subgroups. .. We need to look at the safety issues and assess whether they are addressed. 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. Luis Lederman. 6-10 November, 2017. Morocco. Learning Objectives. After going through this presentation the participants are expected to be familiar with:. UKMi Horizon Scanning Working Group. Jim Glare. West Midlands Medicines Information Service. 11-Nov-2018. Objectives. This presentation aims to give some understanding of:. the ‘life-cycle’ of a medicine. Kent Shigetomi. Office of the U.S. Trade Representative. Overview. What is Good Regulatory Practice?. Why is GRP important?. What are the elements of GRP?. How do you evaluate or measure GRP?. GRP in Trade Agreements. How to engage in broadband policy and regulatory processes” . . Rohan Samarajiva. . Bangalore, April 5-8, 2013. . What the course seeks to achieve. To enable members of Indian civil-society groups (including academics and those from the media)...

Download Document

Here is the link to download the presentation.
"Regulatory Issues Introduction to the Regulatory Approval Process; Overview of the FDA"The content belongs to its owner. You may download and print it for personal use, without modification, and keep all copyright notices. By downloading, you agree to these terms.