'Gov cder' diaporamas de présentation

Ensuring Quality: Priority Essential Medicines

669 views • 47 slides

Training Workshop on Pharmaceutical Development with focus on Paediatric Formulations Protea Hotel Victoria Junction, Wa

Pharmaceutical Development. Training Workshop on Pharmaceutical Development with focus on Paediatric Formulations Protea Hotel Victoria Junction, Waterfront Cape Town, South Africa Date: 16 to 20 April 2007. Pharmaceutical Development. Developing formulation and manufacturing proce ss

872 views • 45 slides

DRUG MASTER FILES

DRUG MASTER FILES. / 45. CONTENTS:-. Introduction Some basic terminologies. Types of DMFS with their contents. Submissions to drug master files Authorization to refer to a drug master file Processing and reviewing policies Holder obligations

2.08k views • 45 slides

VALIDATION of FREEZING BAGS

VALIDATION of FREEZING BAGS. AN SOP. I am not independent, I manufacture freezing bags. I am President of American Fluoroseal Corporation (Afc). AFC has manufactured freezing bags since 1982. AFC bags are marketed by CellGenix GmbH.

551 views • 42 slides

Heart Disease in Women

611 views • 33 slides

Fundamentals of Genetic Toxicology in the Pharmaceutical Industry

Fundamentals of Genetic Toxicology in the Pharmaceutical Industry . Prepared by: David Amacher, Ph.D, DABT www.tigertox.com. What is Genetic Toxicology?.

563 views • 29 slides

Fibromyalgia: Creating a Claim

Fibromyalgia: Creating a Claim. James Witter MD, PhD Arthritis Advisory Committee June 23, 2003. Goals of Meeting. Gather input regarding development and approval for drugs that treat fibromyalgia Enrich analgesic guidance document Address an important public health issue

398 views • 28 slides

EVALUTION OF DOSSIERS IN WHO-PREQUALIFICATION PROJECT MULTISOURCE TB-DRUGS

EVALUTION OF DOSSIERS IN WHO-PREQUALIFICATION PROJECT MULTISOURCE TB-DRUGS. Evaluation of bioavailability/bioequivalence data Based, with some changes on a presentation by Anna-Karin Hamberg Medical products agency, Sweden Presented by Hans Kemmler Consultant to WHO

424 views • 24 slides

Microbiologic Surrogate Endpoints in Clinical Trials-IDSA FDA/IDSA/ISAP Workshop April 15, 2004

412 views • 22 slides

Patent-Extender Drugs: Loop-holes in the Law

403 views • 15 slides

Solomon Iyasu, MD, MPH Medical Team Leader Division of Pediatric Drug Development Center for Drug Evaluation and Researc

One Year Post Exclusivity Adverse Event Review as Mandated by the Best Pharmaceuticals for Children Act Pediatric Subcommittee of the Anti-infective Drugs Advisory Committee Meeting June 9, 2004. Solomon Iyasu, MD, MPH Medical Team Leader

299 views • 11 slides

143 views • 4 slides

General Session 4: Pharmacogenomics

General Session 4: Pharmacogenomics. FDA Pharmacogenomic Guidances. April 2003, CDRH: Multiplex Tests for Heritable DNA Markers, Mutations and Expression Patterns: Draft Guidance for Industry and FDA Reviewers. http://www.fda.gov/cdrh/oivd/guidance/1210.pdf

169 views • 3 slides