Navigation Links
RAPS to Host eCTD Submissions Workshop in Brussels
Date:4/8/2010

First Time in Europe for Popular RAPS Workshop on Electronic Regulatory Submissions

Rockville, MD (Vocus) April 8, 2010 -- Bringing its popular interactive workshop to Europe for the first time, the Regulatory Affairs Professionals Society (RAPS) will host Preparing Compliant eCTD Submissions in Brussels, 5–7 May. This introductory workshop guides participants on how to prepare and submit an electronic Common Technical Document (eCTD), the increasingly accepted global standard for pharmaceutical regulatory submissions to agencies including the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).

The hands-on workshop will be led by renowned expert faculty including Antoinette Azevedo, president, e-SubmissionsSolutions.com, and Hans van Bruggen, MSc, director of Qdossier. Preparing Compliant eCTD Submissions will be held 5–7 May at the Radisson Blu Royal Hotel Brussels. For more information, visit RAPS.org/ectd/may2010.

“Preparing Compliant eCTD Submissions is one of RAPS’ most consistently popular workshops. It has been held numerous times and typically sells out quickly,” said RAPS Executive Director Sherry Keramidas, PhD, CAE. “Bringing this highly-regarded learning opportunity to Europe for the first time is another part of our plans to expand global access to RAPS resources and better serve the needs of regulatory professionals in Europe and throughout the world.”

RAPS opened its European office in Brussels last year and its Tokyo office in 2008.

Learning how to prepare and submit a compliant eCTD is now a core skill for many regulatory professionals. The eCTD format is required by EMA for Centralised Procedure applications and by FDA’s Center for Drug Evaluation and Research. Under the most recent version of the Prescription Drug User Fee Act (PDUFA IV), passed in 2007, FDA will implement a single electronic review environment for all FDA Centers by 2013. Health Canada also implemented an electronic review environment for eCTD submissions this year. However, regulatory authorities receiving eCTD submissions have reported serious problems with lack of compliance with the format and difficulty navigating the electronic files submitted. The aim of the RAPS workshop is to help regulatory professionals develop the necessary eCTD knowledge and skills they may lack.

About RAPS
The Regulatory Affairs Professionals Society (RAPS) is an international membership organization of regulatory professionals in the rapidly growing medical device, pharmaceutical and biotechnology sectors. Regulatory professionals play vital roles in making better healthcare products possible. They work throughout the healthcare product lifecycle, ensuring these products are safe and effective, while driving organizational strategy and sound decision-making. RAPS supports these individuals and the regulatory profession by providing education and training, Regulatory Affairs Certification (RAC), professional standards, research, knowledge-sharing, publications, networking, career development opportunities and other valuable resources; and is committed to helping its members continually develop the knowledge and skills they need to excel. RAPS is headquartered near Washington, DC, with offices in Brussels and Tokyo. RAPS.org

###

Read the full story at http://www.prweb.com/releases/RAPSectd/Brussels/prweb3852464.htm.


'/>"/>
Source: PRWeb
Copyright©2010 Vocus, Inc.
All rights reserved  

Related biology technology :

1. Intrasphere Technologies Releases PharmaCM Submissions Management and Authoring Module Powered by Microsoft Office SharePoint Server 2007
2. Datafarm Releases New Desktop-based Application for Multi-region Viewing of eCTD Submissions: Datafarm VUE
3. International Scientific Workshop Focuses on New Methods for Vaccine and Antibody Development
4. Resverlogix is Presenting at IAS HDL Workshop
5. Campbell Alliance Business Development Practice to Moderate Two Workshops at LES Annual Meeting in Vancouver
6. Vical Presentation at Military Pandemic Influenza Workshop
7. MichBio Announces Annual Meeting Keynote and Pre-Meeting Workshop
8. Campbell Alliance Sales Practice to Conduct Workshop at EyeForPharma SFE Europe Conference
9. MichBio Will Host Workshop on Capital Formation Prior to April 22 Annual Meeting
10. Campbell Alliance Sales Practice to Present Workshop at SPBT Annual Conference
11. Campbell Alliance Clinical Development Practice to Conduct Two Workshops at 44th DIA Annual Meeting
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
RAPS to Host eCTD Submissions Workshop in Brussels
(Date:4/27/2016)... ... April 27, 2016 , ... ... PET (Positron Emission Tomography) and MRI (Magnetic Resonance Imaging) in existing third-party MRI ... testing novel treatments in small animal subjects. Simultaneous PET/MRI imaging offers a solution ...
(Date:4/27/2016)... -- MedDay, a biotechnology company focused on the ... Catherine Moukheibir as Chairman of its Board of Directors. ... Garaud , who contributed to the rapid development of the ... Catherine started her career in strategy consulting and investment banking ... .  She held C-Suite level roles in some of ...
(Date:4/26/2016)... ... 26, 2016 , ... BaseHealth , the comprehensive predictive ... as Chief Business Officer. Arianpour, a genomics pioneer and visionary commercial leader with ... recently Chief Commercial Officer of Pathway Genomics. He has held senior executive roles ...
(Date:4/26/2016)... ... 26, 2016 , ... Mr. Palmer created the RPO business for Ceridian and ... multi-year managed services contract in the U.S. intelligence community with The SI (a Lockheed ... John Younger, founder of Accolo. “We are growing and his experience guiding our ...
Breaking Biology Technology:
(Date:3/29/2016)... , March 29, 2016 LegacyXChange, ... LegacyXChange "LEGX" and SelectaDNA/CSI Protect are pleased to announce ... used in a variety of writing instruments, ensuring athletes ... originally created collectibles from athletes on LegacyXChange will be ... of the DNA. Bill Bollander , ...
(Date:3/22/2016)... PROVO and SANDY, Utah ... (NSO), which operates the highest sample volume laboratory in ... Tute Genomics and UNIConnect, leaders in clinical sequencing informatics ... the launch of a project to establish the informatics ... NSO has been contracted by the ...
(Date:3/17/2016)... LONDON , March 17, 2016 ... market intelligence, forecasts the global biometrics market will ... an impressive 118% increase from 2015. Consumer electronics, ... with embedded fingerprint sensors anticipated to reach two ... Dimitrios Pavlakis , Research Analyst ...
Breaking Biology News(10 mins):