Navigation Links
RAPS to Host eCTD Submissions Workshop in Brussels

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,, 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

“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.


Read the full story at

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:
Related Image:
RAPS to Host eCTD Submissions Workshop in Brussels
(Date:11/25/2015)... (PRWEB) , ... November 25, 2015 , ... ... and the Organization of Black Aerospace Professionals (OPBAP) has been formalized with the ... other AMA team leaders met with OPBAP leaders Capt. Karl Minter and Capt. ...
(Date:11/25/2015)... ... November 25, 2015 , ... ... featured on AngelList early in their initial angel funding process. Now, they are ... individuals looking to make early stage investments in the microbiome space. In ...
(Date:11/24/2015)... 2015 Cepheid (NASDAQ: CPHD ) today ... following conference, and invited investors to participate via webcast. ...      Tuesday, December 1, 2015 at 11.00 a.m. Eastern Time ...      Tuesday, December 1, 2015 at 11.00 a.m. Eastern Time ... New York, NY      Tuesday, December 1, 2015 ...
(Date:11/24/2015)... ... November 24, 2015 , ... Copper is ... it is bound to proteins, copper is also toxic to cells. With a ... Polytechnic Institute (WPI) will conduct a systematic study of copper in the bacteria ...
Breaking Biology Technology:
(Date:11/4/2015)... , November 4, 2015 ... market report published by Transparency Market Research "Home Security Solutions ... and Forecast 2015 - 2022", the global home security solutions ... bn by 2022. The market is estimated to expand ... from 2015 to 2022. Rising security needs among customers ...
(Date:10/29/2015)... 2015  Rubicon Genomics, Inc., today announced an ... its DNA library preparation products, including the ThruPLEX ... Plasma-seq kit. ThruPLEX Plasma-seq has been optimized for ... libraries for liquid biopsies--the analysis of cell-free circulating ... in cancer and other conditions. Eurofins Scientific is ...
(Date:10/27/2015)... 2015 Munich, Germany ... technology (ASGM) automatically maps data from mobile eye tracking ... , so that they can be quantitatively analyzed with ... Munich, Germany , October 28-29, 2015. SMI,s Automated ... mobile eye tracking videos created with SMI,s Eye ...
Breaking Biology News(10 mins):