'Clinical investigations' presentation slideshows

REGULATORY COURSE

REGULATORY COURSE. REGULATORY REQUIREMENTS AND STRATEGIES. REGULATORY COURSE. REGULATORY COURSE. Sponsor Activities: Preclinical Investigations: Identify potential effects of the drug or biologic in the body using laboratory and animal testing Pharmacology, Toxicology

1.44k views • 116 slides

Human Specimen & Data Repositories: Legal and Ethical Challenges

Human Specimen & Data Repositories: Legal and Ethical Challenges. Bioethics Interest Group October 5, 2009. Marianna Bledsoe, MA Clinical Research Policy Analysis and Coordination Program, OBA, OSP, OD, NIH. Disclaimer.

915 views • 68 slides

Human Specimen & Data Repositories: Legal and Ethical Challenges

Human Specimen & Data Repositories: Legal and Ethical Challenges. Bioethics Interest Group October 5, 2009. Marianna Bledsoe, MA Clinical Research Policy Analysis and Coordination Program, OBA, OSP, OD, NIH. Disclaimer.

791 views • 68 slides

821 views • 64 slides

Hematuria

Hematuria. Donald L. Lamm, MD, FACS Bladder Cancer, Genitourinary Oncology Phoenix, AZ BCGOncology.Com. Objectives. Define hematuria and indications for evaluation Describe causes and differential diagnosis Indications for urologic evaluation/referral Advances in kidney cancer

1.48k views • 59 slides

EFFICACY OF CEM-THERAPY

EFFICACY OF CEM-THERAPY. Selection of publications for the clinical test review

796 views • 54 slides

How Philosophy of Science Can Help Biomedical Research

How Philosophy of Science Can Help Biomedical Research. Barry Smith http://ontology.buffalo.edu/smith. How to Do Biology across the Genome?.

641 views • 54 slides

EU Device Regulations

EU Device Regulations A Work in Progress By Rene van de Zande Emergo Group, Inc. Medical Device Regulatory, Reimbursement and Compliance Congress, Harvard University, March 29, 2007. EU Device Regulations. Four Freedom Principles : Movement of Services Capital People Products.

500 views • 49 slides

Judit Milstein Chief, Project Management Staff

CLINICAL INVESTIGATOR How to put together an application?. Judit Milstein Chief, Project Management Staff Division of Special Pathogen and Transplant Products Center for Drug Evaluation and Research Judit.milstein@fda.hhs.gov 301-796-0763. Class outline. Definitions

609 views • 49 slides

The Quality Agenda for UK nephrology

The Quality Agenda for UK nephrology. Charlie Tomson President, Renal Association. SpR club meeting, London, Saturday 18 th September 2010. Conflicts of interest. No financial or other relationships with pharmaceutical companies for at least the last 5 years, in particular no Directorships

501 views • 42 slides

MEDICINE AS A LEARNED AND HUMANE PROFESSION

801 views • 41 slides

ClinicalTrials.gov

530 views • 35 slides

Enablement for Derivatives of Compositions of Matter

Enablement for Derivatives of Compositions of Matter . James O. Wilson Supervisory Patent Examiner Art Unit 1624 571-272-0661. Overview. Statutory Basis - 112 1 st paragraph. How examiners interpret claim language and disclosure as related to invention

846 views • 32 slides

Lynn Henley, M.S., M.B.A. IDE and HDE Programs Food and Drug Administration

Contents of the IDE Application NHLBI June 24, 2010. Lynn Henley, M.S., M.B.A. IDE and HDE Programs Food and Drug Administration. Objectives Today. IDE (Investigational Device Exemption) Exempt device study Significant Risk v. Non-Significant Risk Types of IDEs Contents of Application.

834 views • 32 slides

FDA Regulations Pertaining to Good Clinical Practice and Clinical Trials

FDA Regulations Pertaining to Good Clinical Practice and Clinical Trials. Steven Hirschfeld, MD PhD Office of Cellular, Tissue and Gene Therapy Center for Biologics Evaluation and Research FDA. Fundamentals of Government.

997 views • 30 slides

Overview

Monitoring Vaccine Safety during an Influenza Pandemic Nelson Arboleda, MD, MPH Immunization Safety Office (ISO) Office of the Chief Science officer (OCSO/OD) Centers for Disease Control and Prevention (CDC). Overview. Objectives for vaccine safety monitoring during an influenza pandemic.

421 views • 30 slides

Clinical Investigations:

376 views • 29 slides

ORO Reviews: Frequent Findings Related to IRBs

ORO Reviews: Frequent Findings Related to IRBs. Bob Brooks Associate Director Research Compliance Education and Policy VHA Office of Research Oversight May, 2012. ORO Reviews 2010 Most Frequently Cited Concerns about IRBs.

330 views • 22 slides

Follow-on or Biosimilar Biologic s Points to Consider Paul Kim Foley Hoag LLP Massachusetts Biotechnology Council Thurs

370 views • 17 slides

Figure 3: Pedigree of the affected family. Only two cases of JPS noted

145 views • 1 slides