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

ents/Japan_PressRelease.pdf" onclick="linkClick( this.href );" target="_blank" title="Tokyo office">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

Source: PRWeb
Copyright©2010 Vocus, Inc.
All rights reserved  

Page: 1 2 3

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:11/26/2014)... Texas (PRWEB) November 26, 2014 ... Industryā€¯ is a professional and in-depth research report ... Bifluoride information, like its definition, classification, application, and ... This report covers the international market analysis, including ... as the US, Europe, Asia, China, Japan etc. ...
(Date:11/26/2014)... In keeping with the holiday spirit, ... of last-minute Thanksgiving savings. The company is offering up ... product lines this holiday weekend as well as a ... and Cyber Monday are right around the corner, and ... loyal customers and those looking to explore their ancestry, ...
(Date:11/26/2014)... and PHILADELPHIA , Nov. ... most demanding and unforgiving environments. Human exploration of space ... performance to ensure mission safety and success, and prevent ... performance for mission success, little is known about how ... of cognition are primarily affected. Now, Penn ...
(Date:11/26/2014)... 2014 On January, 14, 2015, ... Washington D.C. science community to the UMBC campus for ... by the Protein Society, will take place from 9 ... 312. Through discussion, presentations and workshops, the free ... proteins, their role in the industry and the future ...
Breaking Biology Technology:Ammonium Bifluoride Market International Analysis of Manufacturing, Technology & Trends Now at ReportsnReports.com 2Ammonium Bifluoride Market International Analysis of Manufacturing, Technology & Trends Now at ReportsnReports.com 3DNA Spectrum Offers Last Minute Thanksgiving Coupons 2DNA Spectrum Offers Last Minute Thanksgiving Coupons 3Penn Medicine Team Develops Cognitive Test Battery to Assess the Impact of Long Duration Spaceflights on Astronauts' Brain Function 2Penn Medicine Team Develops Cognitive Test Battery to Assess the Impact of Long Duration Spaceflights on Astronauts' Brain Function 3Penn Medicine Team Develops Cognitive Test Battery to Assess the Impact of Long Duration Spaceflights on Astronauts' Brain Function 4
... - In an effort to spur growth in ... Wisconsin-Whitewate r graduates, the city of Whitewater ... UW-Whitewater are developing a business incubator, according to a ... which last year received a $10,000 state grant to ...
... where I served as a judge for an industry award contest. ... were locked in a conference room at the Sheraton at ... diligently selected the winners of this year's Medical Design Excellence ... much more recognition, the MDEA winners may very well save your ...
... Corp. has signed a definitive agreement to acquire ... in Quebec City, Canada. , ,Terms of the deal ... close by the end of February. , ,RedPrairie, ... will operate under the RedPrairie name, and RedPrairie's Global ...
Cached Biology Technology:And the winners in medical design are 2And the winners in medical design are 3And the winners in medical design are 4And the winners in medical design are 5And the winners in medical design are 6
(Date:11/4/2014)... (Philadelphia, PA) – Temple University School of Medicine ... Explorations winner, an initiative funded by the Bill ... MPH, Professor of Obstetrics, Gynecology and Reproductive Sciences; ... at Temple University School of Medicine will pursue ... titled "Maternal Blood Biomarkers to Assess Fetal Neurodevelopment.", ...
(Date:11/4/2014)... research study examining only marketing directed at children ... restaurants has found that the majority of black, ... such marketing tactics. , Authored by Arizona State ... study is the first to examine the use ... of fast food restaurants and its relationship to ...
(Date:11/4/2014)... – (Nov. 4, 2014) – A majority of Madagascar,s ... that could have serious consequences for the rainforests they ... shows the positive impacts lemurs can have on rainforest ... their disappearance could have on the region,s rich biodiversity. ... have fruits eaten by lemurs. Lemurs in turn ...
Breaking Biology News(10 mins):Temple University School of Medicine receives Grand Challenges Explorations grant 2Fast food marketing for children disproportionately affects certain communities 2Fast food marketing for children disproportionately affects certain communities 3Gardeners of Madagascar rainforest at risk 2Gardeners of Madagascar rainforest at risk 3
... a great pace compared to the relatively small funds ... This is one of the main conclusions from a ... Councils (EMRC) the European Science Foundation,s membership organisation ... EMRC White Paper, entitled ,A Stronger Biomedical Research for ...
... have for the first time identified a ,programmed cell ... lead to new treatments for one of the world,s ... and Dr Doug Fairlie from the institute,s Structural Biology ... human cells. They have recently started studying the process ...
... Department of Energy,s Savannah River National Laboratory and the ... a special issue of the Health Physics Journal ... Chernobyl Exclusion Zone 25 Years After the Accident," ... the DOE Office of Environmental Management,s (EM) International Program, ...
Cached Biology News:Europe 'punches above its weight' in biomedical research, despite limited funding 2Worm 'cell death' discovery could lead to new drugs for deadly parasite 2Journal focuses on Savannah River National Labratory, Chernobyl Laboratory collaboration 2Journal focuses on Savannah River National Labratory, Chernobyl Laboratory collaboration 3
Sheep polyclonal to Staphylococcus DNase ( Abpromise for all tested applications). Antigen: Full length native protein (purified)....
Mouse anti-hepatitis delta virus Class: Antibody Product Group: Bacterial and Viral Antigen...
Allophycocyanin (APC) anti-human CD193 (CCR3, CKR3) 25 tests...
Mouse monoclonal [YLI-90] to Ly49I (Biotin) ( Abpromise for all tested applications)....
Biology Products: