Meet Inspiring Speakers and Experts at our 3000+ Global Conference Series Events with over 1000+ Conferences, 1000+ Symposiums
and 1000+ Workshops on Medical, Pharma, Engineering, Science, Technology and Business.Explore and learn more about Conference Series : World's leading Event Organizer
As per available reports about 05 relevant journals, 06 Conferences, 05 Workshops are presently dedicated exclusively to Auditing and about 24 articles are being published on Investigational drugs.
International standards are standards developed by international standards organizations. International standards are available for consideration and use worldwide. One prominent organization is the OMICS International Organization for Standardization. International standards may be used either by direct application or by a process of modifying an international standard to suit local conditions.
OMICS International Organizes 1000+ Global Events every Year across USA, Europe & Asia with support from 1000 more scientific societies and Publishes 700+ Open access journals which contains over 100000 eminent personalities, reputed scientists as editorial board and organizing committee members. The conference series website will provide you list and details about the conference organize worldwide.
Scope and Importance:
The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved. The FDA reviews the IND application for safety to assure that research subjects will not be subjected to unreasonable risk. If the application is cleared, the candidate drug usually enters a Phase 1 clinical trial.
An IND is required for a clinical study if it is intended to support a:
• New indication
• Change in the approved route of administration or dosage level
• Change in the approved patient population (e.g. pediatric) or a population at greater or increase of risk (elderly, HIV positive, immunocompromised)
• Significant change in the promotion of an approved drug
There are three IND types:
• An Investigator IND is submitted by a physician who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed. A physician might submit a research IND to propose studying an unapproved drug, or an approved product for a new indication or in a new patient population.
• Emergency Use IND allows the FDA to authorize use of an experimental drug in an emergency situation that does not allow time for submission of an IND.
• Treatment IND is submitted for experimental drugs showing promise in clinical testing for serious or immediately life-threatening conditions while the final clinical work is conducted and the FDA review takes place.
List of Best International Conferences:
• International Conference and Expo on Biopharmaceutics, September 21-22, Baltimore 2015
• International Conference on Case Reports, March 31-April 02, 2016 Valencia, Spain
• 2nd International Meeting on Clinical Case Reports, April 18-20, 2016 Dubai, UAE
• 3rd Experts Meeting on Medical Case Reports May 09-11, 2016 New Orleans, Louisiana, USA
• 2nd International Conference and Exhibition on Molecular Medicine and Diagnostics, September 26-28, 2016 Miami, USA
Societies and Associations on oral products:
American Heart Association Scientific Sessions
International Scientific Association for Probiotics and Prebiotics
Symposiums on International regulatory standards:
• International Symposium on Fan Efficiency Regulation
• SAE 2015 On-Board Diagnostics Symposium - Europe ..
. • Symposium on New Approaches to International RegulatoryCooperation
• 6th International Symposium on Release of Radioactive Materials from Regulatory Requirements
• 2014 International Nurse Regulator Collaborative Symposium
• Symposium on Changing Regulations and Standards for Medical Device Software and Health Information Systems
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This page was last updated on November 21, 2024
