alexa
Reach Us +1-217-403-9671
Comparison Of European Medicines Agency (EMA) And Food And Drug Administration (FDA) Procedures For Evaluating Scientific And Regulatory Issues Of Clinical Studies During The Development Of Medicinal Products: Experience Of A Global Imaging Clinical Research Organization | 7536
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)

2nd International Conference and Exhibition on Pharmaceutical Regulatory Affairs

K. Ludajic and J. Hicks
Accepted Abstracts: Pharmaceut Reg Affairs
DOI: 10.4172/2167-7689.S1.008
Abstract
Here we compare the procedures for obtaining pre-approval for the Clinical Study Protocols and accompanying documentation by two regulatory agencies - European Medicines Agency (EMA) and Food and Drug Administration (FDA). The procedures called Scientific Advice and Protocol Assistance (SA/PA), and Special Protocol Assessment (SPA), respectively, are compared in terms of duration, scope, cost and possible outcomes. In addition, we discuss the reasons why our clients submitted more than fifty Independent Review Charters (IRC, a document which governs the independent review process) as accompanying material for SPA to FDA, and to our knowledge none for SA/PA to EMA. Research of publicly available documents and company-wide investigation showed that the two procedures are similar in design and purpose. If the sponsor and the agency agree on the design, execution and analyses proposed in the submitted documentation, the agreement becomes part of the administrative record. The agreement is not legally binding on either of the Agencies; however, complying with the agreement significantly shortens the duration of the marketing authorization applications and increases its success. Our data show that pre-approval procedures, if employed, offer a clear benefit to clients; therefore they should be explained and recommended to all clients targeting global markets.
Biography
Katarina Ludajic is a Senior Medical Writer at Perceptive Informatics. She earned a B.S. in Biology at the University of Belgrade, Serbia and Ph.D. in Molecular Biology at the Friedrich-Schiller University in Jena, Germany. She has completed her post-doctoral training at the General Hospital of Vienna, Austria where she performed research in the field of Transplantation Biology. She is the first author on multiple scientific articles published in peer-reviewed journals.
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

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

https://www.gaziantepescort.info

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