The instructions mentioned in the document applicable only
for paper dossier.
Please use the below mentioned weblink to find more
information.
17 July 2012
12 July 2012
Regulatory Submissions: Filling the Critical Gaps in EDM Systems - By Patricia Santos-Serrao
It's been said that electronic document management (EDM)
systems for the management of submission documents are "a dime a
dozen." However not all EDM systems are created equal, at least not when
it comes to the management of final submission documents. Many of us are
familiar with the standard functionality that most EDM systems provides
particularly in the life sciences space such as: document types, taxonomy,
version control, lifecycle management, securities, PDF rendering, watermarks,
and electronic signatures just to name a few.
Although the challenges of migrating from paper-based
submissions to electronic are numerous, they are also subjective based on a
company's current infrastructure and culture. The top challenges faced by a
pharmaceutical or biotech company looking to transition to electronic common
technical document (eCTD) format for regulatory submissions often include:
select a vendor / solution, configure system to support specific needs, train
users on system, and roll-out/implement the tools.
To find more information please use the below mentioned link
Apex Regulatory's Blog: eCTD: Literature in the Article 8(3) Mixed Application (EU)
This short post concerns the submission of Literature
References in "Full Mixed" applications under Article 8(3). I don't
think it is discussed in any eCTD specific guidance (or if it is, I couldn't
find it!) so I thought it might be useful to share this information with you.
Article 8(3) applications are full MAA applications detailed
in Directive 2001/83/EC. This type of application normally requires the
submission of the results of both pre-clinical and clinical trials in Modules 4
and 5.
There does exist, however, the option to submit what is
described as a "full mixed" application which contains literature
references in place of (rather than to supplement) Study Reports. The content
of these references must therefore fulfil the requirements of the Directive:
To find more information please use the below mentioned link
10 July 2012
eCliniqua: 2012 Survey Demonstrates Growth in eTMF and Impact of Standards
In June 2010, an industry coalition, under the auspices of the Drug Information Association, published version 1.0 of the Trial Master File Reference Model (TMF RM). The Trial Master File (TMF) contains those essential documents that individually and collectively permit the evaluation of the conduct of a clinical trial and the quality of the data produced. Until this version of the TMF RM was released, there was no comprehensive common industry model for the TMF.
The TMF RM presents a consensus position on the content that supports the evaluation of the conduct of a trial and the quality of the data produced, in accordance with industry opinion and best practices. By design, the TMF RM is a guidance and not a regulatory standard. The team that developed the TMF RM is composed of approximately 275 representatives from more than 165 biopharmaceutical companies, contract research organizations (CROs), consultancies, vendors, industry groups, healthcare, academia, non-for-profit / NGO and regulatory agencies.
To find more information please use the below
mentioned weblink
The eCTD Summit: Regulatory Submissions: Paper vs. Electronic
The
migration from what is still a manually driven, physically intensive
process to a simplified automated task may seem daunting, but in
reality, half the battle is already won. Applications are no longer
written and transcribed by typewriters; they’re created electronically
with word processing software. Electronic compilation with applicable
submission software versus manual collation further expedites the
process. The added cost and time delays required by man-hours to print
and assemble dossiers adds even more time to process your submission, in
turn delaying the approval process.
To find more information please use the below
mentioned weblink
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