'Fda guidance' diaporamas de présentation

Regulatory Submission Datasets in the World of Evolving Standards

1.14k views • 63 slides

Waivers of in-vivo BE studies

552 views • 41 slides

The Role of Adverse Events in Evaluating the Abuse Potential of New Drugs

The Role of Adverse Events in Evaluating the Abuse Potential of New Drugs. A. J. Allen, M.D., Ph.D., Sr. Med. Fellow Cochair , Lilly Drug Abuse Liability & Dependence (Safety) Advisory Committee Eli Lilly and Company Allenaj@Lilly.com. Financial Disclosures. Overview.

480 views • 36 slides

Is your clinical data ready for submission?

513 views • 35 slides

Pro : The Autologous Cartilage Tissue Implant

Pro : The Autologous Cartilage Tissue Implant. Thomas M. DeBerardino, MD Professor of Orthopaedic Surgery, Baylor College of Medicine Co-Director, Baylor-San Antonio, Texas Sports Medicine Fellowship The San Antonio Orthopaedic Group Medical Director, BRIO. Disclosure.

308 views • 30 slides

The ABCs of BPDs

Presented by Karen Dosanjh Quality Director Blood Systems. The ABCs of BPDs. Disclosure. I have no relevant financial relationships to disclose. Learning Objectives. Describe a scenarios that would be reportable as a BPD. Recognize when patient lookback is required.

297 views • 28 slides

Premarketing Risk Assessment

458 views • 23 slides

CDISC Controlled Terminology

CDISC Controlled Terminology. HITSP Harm. Subcommittee 1 October 2008 Bron Kisler (CDISC) bkisler@cdisc.org. CDISC Snapshot. Global standards organization initiated in 1997 as a volunteer group; incorporated as non-profit in 2000

606 views • 22 slides

Challenges, trends and Strategies in TCM Development

293 views • 20 slides

Nuts and Bolts: You Too Can Prepare an IND

DCTD Phase 0 Workshop. Nuts and Bolts: You Too Can Prepare an IND. Paula M. Jacobs, Ph.D. SAIC Frederick Cancer Imaging Program/DCTD/NCI/NIH September 5, 2006 Phase 0 Trials in Oncologic Drug Development. Overview of Early Development. Synthesize a number of new imaging drugs

176 views • 17 slides

CDER IND/NDA Reviews Guidance, The Common Technical Document and Good Review Practice

CDER IND/NDA Reviews Guidance, The Common Technical Document and Good Review Practice. John K. Leighton, Ph.D., DABT CDER/FDA. Overview. Current IND/NDA review process FDA/ICH guidance Common Technical Document CDER Pharmacology Good Review Practice. Review Team. Project Managers

171 views • 15 slides

Presented by 612 492 7336 rklepinski@fredlaw.com

Ace Medical Promotion. Presented by 612 492 7336 rklepinski@fredlaw.com. Bob Klepinski. Ace Promotion before Clearance/Approval. There are basic differences in promotion of 510(k) vs. PMA devices FDA jurisdiction is different and policies/guidance differ. 510(k).

290 views • 13 slides

The Dun & Bradstreet Data Universal Numbering System

465 views • 13 slides

Useful Medication Information for Consumers

Useful Medication Information for Consumers. Gerald K. McEvoy, Pharm.D. Assistant Vice President, Drug Information Editor in Chief, AHFS Drug Information American Society of Health-System Pharmacists FDA Public Hearing, February 26 and 27, 2009. ASHP.

250 views • 13 slides

254 views • 11 slides

Various other updates

Various other updates. Presented by: Karen S Ginsbury March 2012. FDA Process Validation Guidance. Finalized January 2011

165 views • 9 slides

REGULATORY CONSIDERATIONS FOR NANOTECHNOLOGY IN PUBLIC HEALTH

REGULATORY CONSIDERATIONS FOR NANOTECHNOLOGY IN PUBLIC HEALTH. FOOD AND DRUG ADMINISTRATION Norris E. Alderson, Ph.D. Senior Associate Commissioner for Science. FDA REGULATES. 20 percent of the consumer purchases $50 billion of medical R&D 8 million import shipments/year

236 views • 8 slides

Validation of Analytical Methods according to the New FDA Guidance

FDA has released a new comprehensive guidance for validation of analytical methods. The guidance follows the modern integrated lifecycle approach with related new requirements for using quality-by-design components, risk assessment, design space and continuous improvement. The guidance will significantly change the way how FDA regulated methods will be developed, validated and used. Because of the novelty of some of the concepts the industry has difficulties to understand and implement the guidance. Attendees of this seminar will understand and learn how to implement the new guidance.

255 views • 5 slides