Posts

Successful eCTD Implementation in China: 3 Lessons Learned

China is the most populous country on the planet accounting for more than 18% of the world’s population. Following the focus placed on biopharmaceutical development by the Chinese government in the last decade, the country’s global industry ranking rose from 9th largest in 2007 to 2nd in 2017. 

To help expedite the review and approval of new medicines, China will soon join other Asia Pacific countries in accepting submissions in a fully electronic eCTD format. The implementation of eCTD in Japan and Thailand highlighted many hurdles for both domestic and international biopharmaceutical companies, some of which can be avoided.

CFDA eCTD Adoption

After joining the ICH (International Conference on Harmonization) in June 2017, China’s draft eCTD guidance has now been provided by the CFDA (China Food & Drug Administration). It is time for any organisation looking to gain approval for their products in the Chinese market to prepare to take advantage of this regulatory change.

5-Step Automation: Reduce Risks in Correspondence Tracking

Life Sciences organizations deal with external parties and health authorities on a regular basis. Given the amount of information, tracking all that communication is very challenging and burdensome. 

“An essential part of any complete RIM platform

is the ability to plan and track all regulatory

activities that an organization needs to undertake.”

These activities are often initiated by a request from a health authority for more information, It is critical that these requests are traceable alongside the tracked regulatory activities in the RIM platform.

Read more

Introducing DocShifter, the Switzerland of Advanced Rendering

In our previous posts, we introduced our understanding of what Advanced Rendering is.

We shared why this Advanced Rendering is more than just having the right technology in place and set out 3 guiding principles on how this can be improved.

For an enterprise to get a grip on all the benefits of sharing, broad usage throughout the entire life cycle of a document and automation, various technical features must be there to make this happen. We will now focus on those technical features which a rendering system needs in order to be truly advanced.

Enter DocShifter.

 

Read more

3 Guiding principles when implementing Advanced Rendering in Life Sciences

In our previous post, we introduced our understanding of what advanced rendering is. Why is  this more than just having the right technology in place? The first step is to make an inventory throughout the enterprise of all rendering processes in place today. This is crucial to evaluate the as-is-situation. Subsequently, we share 3 guiding principles on how that existing process can be improved.

1. Think about the entire document life cycle

Advanced rendering is a lot more than just producing a high quality technically compliant output document right before the submission. When we introduce advanced rendering in the lifecycle of the document, then, in that moment, possibilities become endless.

Read more

What are the key disruptors for Life Sciences?

Every industry goes through changes over time and the Life Sciences industry is no exception. But not every change is significant. With so many buzzwords and jargon being thrown around, sometimes it’s hard to wade through the noise and get to the heart of it all.

Read more

6 good reasons why leading Life Sciences companies are rethinking their Document Rendering Solution

We have been converting divergent documents into a unified format such as PDF for many years now.

In knowledge-driven industries such as Life Sciences in particular, the need for standardization is highly motivated by the regulators. The introduction of the electronic Common Technical Document (eCTD) has accelerated the move from paper to electronic formats. And the International Conference on Harmonization (ICH) has further solidified this drive in its recent implementation guides for Regulated Product Submissions (RPS). Read more

What’s next after eCTD?

Life sciences companies face enormous challenges to comply to the increasingly complex regulatory environments. More and more companies adopt the fully electronic eCTD submission format. In the meantime, the industry is already preparing for major revisions to the way in which information is provided to the health authorities. So, what is next and how will it impact both the sponsors and health authorities alike? Read more

DACHS Biosciences and DocShifter Partner Up to Help Life Sciences Companies Deal With the Growing Challenges Around Advanced Document Conversion

We are proud to announce our new partnership with DACHS to meet the growing needs for document conversion & enrichment in the Life Sciences industry.  The advanced content conversion capabilities of DocShifter combined with the expertise of DACHS in document management for pharmaceutical companies make a powerful strategic alliance.  Read more

Network with us at the TOPRA healthcare regulatory affairs conference 2018

The TOPRA Annual Symposium 2018 is the only Europe-wide healthcare regulatory affairs conference with comprehensive programmes covering medical technologies, human and animal medicines – this year held in partnership with the Swedish MPA at the Quality Hotel Globe in Stockholm from 1–3 October 2018.

Read more

Frequently asked questions on the eCTD format (Part 2)

The electronic submission requirements (CDER/CBER) will apply to the following types of submissions: Read more

Events

DIA Europe Brussels 2020

DIA Europe Brussels 2020

DIA Europe is a must-attend event for life science professionals from across the entire drug development spectrum – from discovery to marketed use – to facilitate open collaboration by incorporating representatives from the full life sciences landscape. Thought-provoking, worldwide issues will be deconstructed by acclaimed panelists representing multiple stakeholders from around the world in this growing ecosystem of life sciences.

DIA Europe facilitates open collaboration by including representatives from the full life science landscape and ensuring Patients, Regulators, Payers and Industry all have an equal voice across several topic Tracks, including Clinical Development & OperationsRegulatory Science & Regulatory OperationsValue and AccessMedical Affairs and many others.

RAPS Europe Brussels 2020 | DocShifter

DocShifter provides document transformation solutions to Life Sciences:compliant submission ready PDF, automating correspondence tracking, PDF/A conversion for digital archiving, legacy document transformation and automating the creation of standard templated forms. More information can be found here.

DIA RSIDM 2020

DIA RSIDM 2020 – Regulatory Submissions, Information and Document Management Forum

A brief conversation and your Belgian chocolate is waiting for you at the DIA RSIDM conference.


Click here to schedule a moment to pick up your chocolate.

 

About DIA RSIDM 2020

DIA’s Regulatory Submissions, Information, and Document Management Forum provides the elements needed to meet the challenges of optimizing the efficient use of regulatory information: the RIM principles, effective processes and tools, benefits to data applications across the product lifecycle, and examination of real-life results. DIA will present four tracks and daily health authority plenary sessions to provide a comprehensive view of content and regulatory information management and submissions. All tracks are supported with daily plenary sessions providing regulatory intelligence updates by health authority representatives from FDA, Health Canada, and other regions of interest.

DIA RSIDM Official 2020

DocShifter provides document conversion solutions to pharmaceuticals and life sciences: compliant submission ready PDF conversion, automating correspondence tracking, PDF/A conversion for digital archiving, legacy document transformation and automating the creation of standard templated forms.