alexa Quality System Controls For Clinical Trial Development And Conduct | 13809
ISSN: 2167-7689

Pharmaceutical Regulatory Affairs: Open Access
Open Access

OMICS International organises 3000+ Global Conferenceseries Events every year across USA, Europe & Asia with support from 1000 more scientific Societies and Publishes 700+ Open Access Journals which contains over 50000 eminent personalities, reputed scientists as editorial board members.

Open Access Journals gaining more Readers and Citations
700 Journals and 15,000,000 Readers Each Journal is getting 25,000+ Readers

This Readership is 10 times more when compared to other Subscription Journals (Source: Google Analytics)

3rd International Conference on Pharmaceutical Regulatory Affairs

Lee Truax-Bellows
Accepted Abstracts: Pharmaceut Reg Affairs
DOI: 10.4172/2167-7689.S1.012
Abstract
Clinical studies continue to fail to meet the minimum regulatory requirements as shown by worldwide regulatory citations that are issued on a fairly consistent basis. What is even more concerning is that these areas remain year after year and include inadequacy in; study oversight, protocol compliance, investigational product accountability, training, and ethical committee oversight. With all the emphasis on training that many sponsors and investigators put their staff through, the guidance documents issued by the regulatory authorities, continued negative inspections and resulting citations, which in turn result in negative publicity, why does this continue to happen in this day and age? Applying a quality system approach, including the conduct of risk management techniques, will help ensure that industry and their partners, such as third party vendors and site personnel, are better prepared to identify and plan for potential risk areas, plus deal with issues as they arise. This session will introduce the concepts and application of a quality system approach to study management for regulated clinical trials to ensure adequate risk assessment, evaluation and application for superior performance. It will provide direction on a practical approach to incorporating it into the practice of daily clinical research activities. The session is geared towards intermediate participants at both the site and sponsor level who already have a good understanding in the requirements of clinical research, but are seeking further direction in how to execute clinical research from a quality systems approach. Objectives: Upon completion of this program participants will be able to: 1. Relate the concepts of a quality system approach to the conduct of clinical trials 2. Define risk management principals 3. Identify how corrective and preventative action plans apply to a clinical quality system approach
Biography
Lee Truax-Bellows is a founder, president and CEO of Norwich Clinical Research Associates Ltd. (NCRA). NCRA is a full service clinical contract research organization (CRO) based in upstate NY. Lee has an extensive background in the pharmaceutical and medical device industries, having worked for both industry and a CRO as a Monitor, Medical Communications Associate, Project Manager, Senior Quality Auditor, Senior Trainer, and Regulatory and SOP Consultant. Lee has been involved in regulated research for 20 plus years and currently specializes in product development, GCP auditing, SOP development and training on regulated research and Good Clinical Practice. Lee is an active member of the Association of Clinical Research Professionals (ACRP), New York State MedTech Association and Society of Quality Assurance (SQA). Lee is ACRP certified as a Certified Clinical Research Associate (CCRA) and registered through SQA as a Registered Quality Assurance Professional in Good Clinical Practices (RQAP-GCP).
image PDF   |   image HTML
 

Relevant Topics

Peer Reviewed Journals
 
Make the best use of Scientific Research and information from our 700 + peer reviewed, Open Access Journals
International Conferences 2018-19
 
Meet Inspiring Speakers and Experts at our 3000+ Global Annual Meetings

Contact Us

Agri & Aquaculture Journals

Dr. Krish

[email protected]

+1-702-714-7001Extn: 9040

Biochemistry Journals

Datta A

[email protected]

1-702-714-7001Extn: 9037

Business & Management Journals

Ronald

[email protected]

1-702-714-7001Extn: 9042

Chemistry Journals

Gabriel Shaw

[email protected]

1-702-714-7001Extn: 9040

Clinical Journals

Datta A

[email protected]

1-702-714-7001Extn: 9037

Engineering Journals

James Franklin

[email protected]

1-702-714-7001Extn: 9042

Food & Nutrition Journals

Katie Wilson

[email protected]

1-702-714-7001Extn: 9042

General Science

Andrea Jason

[email protected]

1-702-714-7001Extn: 9043

Genetics & Molecular Biology Journals

Anna Melissa

[email protected]

1-702-714-7001Extn: 9006

Immunology & Microbiology Journals

David Gorantl

[email protected]

1-702-714-7001Extn: 9014

Materials Science Journals

Rachle Green

[email protected]

1-702-714-7001Extn: 9039

Nursing & Health Care Journals

Stephanie Skinner

[email protected]

1-702-714-7001Extn: 9039

Medical Journals

Nimmi Anna

[email protected]

1-702-714-7001Extn: 9038

Neuroscience & Psychology Journals

Nathan T

[email protected]

1-702-714-7001Extn: 9041

Pharmaceutical Sciences Journals

Ann Jose

[email protected]

1-702-714-7001Extn: 9007

Social & Political Science Journals

Steve Harry

[email protected]

1-702-714-7001Extn: 9042

 
© 2008- 2018 OMICS International - Open Access Publisher. Best viewed in Mozilla Firefox | Google Chrome | Above IE 7.0 version
Leave Your Message 24x7