'Advisory committee meeting' presentation slideshows

Division of Anti-Infective and Ophthalmology Products Advisory Committee Meeting for Difluprednate

Division of Anti-Infective and Ophthalmology Products Advisory Committee Meeting for Difluprednate. Sonal D. Wadhwa, MD US Food and Drug Administration Medical Officer May 29, 2008. Applicant Information. Applicant: Sirion Therapeutics 3110 Cherry Palm Drive, Suite 340

648 views • 41 slides

Synopsis of 1987 Aseptic Processing Guidance Revision

Synopsis of 1987 Aseptic Processing Guidance Revision. Updating the Aseptic Processing Guidance. Original 1987 Guidance Document: Written circa 1980 in lieu of regulations Guidance route provided latitude Need for updated CGMP guidance on high risk area of sterile drugs.

756 views • 40 slides

PMI Dutch Chapter Meeting 22 Feb 2011

FDA Advisory Committee Meeting: The management of an acceptance test for a new medicine by external stakeholders Jan W.C.M Jansen Global Project Director Abbott Healthcare Products Weesp, The Netherlands. PMI Dutch Chapter Meeting 22 Feb 2011. Who is Jan Jansen?.

492 views • 38 slides

How To Form an Effective Advisory Committee

How To Form an Effective Advisory Committee. Presenters: Maria Clinton & Maggie Drake. Functional and Effective Advisory Committees. The purpose of this Flex presentation is to equip faculty and staff with the basic understanding and tools to form or enhance their Advisory Committees.

285 views • 28 slides

Ketek ? (telithromycin) Regulatory History

Ketek ? (telithromycin) Regulatory History. Janice Soreth, M.D. Director Division of Anti-Infective & Ophthalmology Products CDER/FDA. Ketek Regulatory History: Outline. US Submissions: 1998-2004 3 Review Cycles Two Advisory Committees: April, 2001; January, 2003

424 views • 23 slides

Preparation for FDA Advisory Committee Meetings

478 views • 18 slides

FDA Good Guidance Practices (GGP)

Development of Guidance Documents Jennifer Scharpf, M.P.H. Associate Director for Policy and Communication Office of Blood Research and Review, CBER September 15, 2009. FDA Good Guidance Practices (GGP).

357 views • 17 slides

Turning Points in American History Knowledge. Understanding. Perspectives.

270 views • 17 slides

Torch Awards

Torch Awards. 2013 - 2014. P rogram that frames and guides a members leadership and service to their chapter and community. What are Torch Awards?. Leadership Service Cooperation Knowledge Friendship Love, Hope, and Faith Patriotism . There are seven categories.

316 views • 16 slides

Suicidality and Anti-epileptic Drugs: Status of Clinical Trial Data Analysis

Suicidality and Anti-epileptic Drugs: Status of Clinical Trial Data Analysis. Evelyn Mentari, MD, MS Division of Neurology Products. Background.

247 views • 15 slides

230 views • 13 slides

ADVISORY COMMITTEES

426 views • 10 slides

Midwest ISO Stakeholder Process

228 views • 10 slides

Midwest ISO Stakeholder Process

105 views • 10 slides

Status Report on Independent Review of MetroAccess

Status Report on Independent Review of MetroAccess. July 24, 2008 Access for All Advisory Committee Meeting. Primary Review Areas. Service Quality and Performance Monitoring Eligibility Determinations Rider Input and Customer Service Policy and Planning. Timeline for Independent Review.

133 views • 4 slides

Workplace Digital Essential Skills for Rural Small and Medium Size Businesses Pilot Project

Workplace Digital Essential Skills for Rural Small and Medium Size Businesses Pilot Project. Advisory Committee Meeting No. 3 Campbellton , NB, June 6, 2013. Outline. Basic Definitions Pre-ONA Pre-ONA Results. Basic Definitions. Eligible participants (employees) Targeted sectors

116 views • 0 slides