'New drug application' presentation slideshows

Critical Thinking in Medicine

1.63k views • 66 slides

Critical Thinking in Medicine

1.01k views • 66 slides

Development and Approval of Drugs and Devices EPI260 Lecture 1: Overview April 1, 2010 Richard Chin, M.D.

Development and Approval of Drugs and Devices EPI260 Lecture 1: Overview April 1, 2010 Richard Chin, M.D. Course Objective. Provide a survey of drug and device development from late preclinical through Phase 3 clinical studies. Course Outline. Overview

761 views • 54 slides

Positioning Nutritional Food Products

621 views • 51 slides

General Pharmacology

707 views • 46 slides

Pharmaceuticals

628 views • 42 slides

Pharmaceuticals

Pharmaceuticals. HSPM J712 11/10/2010. What is the real product of the drug industry?. Drugs? New drugs? Prices of brand name drugs >> marginal cost of production Industry argues that the prices of new drugs reflect the cost of research and development

516 views • 35 slides

Stephen T. Parente, Ph.D. $ $ Carlson School of Management, Department of Finance

University of Minnesota Medical Technology Evaluation and Market Research Department of Healthcare Management Course: MILI/PUBH 6589 Spring Semester, 2012. Stephen T. Parente, Ph.D. $ $ Carlson School of Management, Department of Finance.

485 views • 34 slides

Design of Case Report Forms

Design of Case Report Forms. David W. Mailhot February 7, 2006. Case Report Form. ..CRF Official clinical data-recording document or tool used in a clinical study. RDC/RDE (Remote Data Capture, Remote Data Entry). PAPER. Purpose. Collects relevant data in a specific format

2.12k views • 33 slides

Design of Case Report Forms

Design of Case Report Forms. David W. Mailhot February 14, 2005. Case Report Form. ..CRF Official clinical data-recording document or tool used in a clinical study. RDC/RDE (Remote Data Capture, Remote Data Entry). PAPER. Purpose. Collects relevant data in a specific format

4.67k views • 33 slides

FDA IND Review: Regulations and Challenges

FDA IND Review: Regulations and Challenges. Wilson W. Bryan, M.D. FDA / CBER / OCTGT wilson.bryan@fda.hhs.gov Workshop on Cell and Gene Therapy Clinical Trials in Pediatric Populations North Bethesda, Maryland November 2, 2010.

855 views • 24 slides

Billing 3 rd Party Payors for Services as part of Clinical Research

Billing 3 rd Party Payors for Services as part of Clinical Research. Presented by OCRA to the Research Committee March 3, 2010. Background of CMS Clinical Trials Policy National Coverage Determination (NCD).

398 views • 24 slides

Ricin

Ricin. Possible Treatment for Cancer?. What is Ricin?. A poison found naturally in beans of caster bean plant, Ricinus communis Family Euphorbiaceae Native to tropical Africa Can be in form of powder, mist, or pellet, or dissolved in water or weak acid

1.28k views • 23 slides

BROKERS ASSOCIATION SEMINAR SPECIAL PRODUCT REQUIREMENTS

BROKERS ASSOCIATION SEMINAR SPECIAL PRODUCT REQUIREMENTS. January 22, 2009 Chicago District/FDA. Ryan Gibson, Investigator. Human Drugs Animal Drugs Medical Devices Medical Devices That Emit Radiation Non-Medical Devices That Emit Radiation Devices: Sunglasses/Reading Glasses Regulations

393 views • 21 slides

Chapter 4 Cultural, Legal, & Ethical Considerations

485 views • 20 slides

Discuss the Strategies to Increase the Number of Excipients Labeled USP-NF October 10-11, 2006 DISCUSSION TOPIC D Closin

Discuss the Strategies to Increase the Number of Excipients Labeled USP-NF October 10-11, 2006 DISCUSSION TOPIC D Closing Presentation. Moderator: Barbara Ferguson Scribes: Catherine Sheehan Dr. Hong Wang. 1.a. What are the barriers to labeling an excipient as USP-NF grade?

374 views • 17 slides

Exception to Informed Consent Under Emergency Circumstances (21 CFR 50.24)

Exception to Informed Consent Under Emergency Circumstances (21 CFR 50.24). Tom P. Aufderheide, M.D., FACEP, FAHA Professor of Emergency Medicine Associate Chair of Research Affairs Medical College of Wisconsin. Presenter Disclosure Information. Tom P. Aufderheide, M.D., FACEP, FAHA

490 views • 17 slides

Intro to medicine Prescription vs. over-the-counter Labeling Medicine misuse Medicine Safety

Using Medicines Wisely. Intro to medicine Prescription vs. over-the-counter Labeling Medicine misuse Medicine Safety. What is Medicine?. Prevents or cures a disease or medical problem Classified according to effect on body a. Prevent disease b. Fight pathogens c. Relieve pain

464 views • 15 slides

Patent-Extender Drugs: Loop-holes in the Law

403 views • 15 slides

Alternative Careers in Pharma and Biotechnology

Alternative Careers in Pharma and Biotechnology. Douglas Buckley Ph.D. May 13, 2011 Alternative Career Symposium Baylor College of Medicine. Outline. Company organization Scientific roles in various divisions Jobs that span the continuum Impacts of organization size

259 views • 13 slides