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How to accelerate content preparation for regulatory submissions.
A case study by Pharmalex.
Regulatory submissions are one of the most critical milestones for Life Sciences organizations and can consist of thousands of documents. Submitting on time and in full compliance with Regulatory Agencies’ requirements remains a challenge for many companies.
Today, many Life Sciences companies still struggle with their submission content preparation; manual steps involved introduce risks and slow down submissions.
Fully automating your content preparation for regulatory submissions is possible.
Join our webinar, and discover how you can accelerate your submission content preparation.
Jennie May, Director, Regulatory Informatics and Operations at PharmaLex, a global solution provider, will also explain how they have simplified this process at PharmaLex for their global customers.Â
Key Learnings
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- Discover how to implement a proven document conversion and validation solution for pharmaceutical, biotech and medical device companies
- Â Learn about the software that automates, accelerates and simplifies the way to create submission-ready PDFs from original source documents; no matter which system these documents reside in
- Â Enrich your knowledge on how to streamline the eCTD publishing process, from the technological and workflow perspectives
How to auto check and fix Word and PDF documents for compliance
You want to make sure that Microsoft Word & PDF documents meet compliance guidelines. And that they are fixed automatically if they don’t.
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By watching the recording, you learn more about:Â
- Automate the formatting checks and fixes of your Microsoft Word documents for compliance (both regulatory and corporate compliance)
- Automate the validation of PDF files against Health Authority guidelines
- Incorporate the Word and PDF checks and fixes into your rendering process
- Save valuable time and reduce the risk of non-compliance in your submission process
The secrets to a successful enterprise (PDF) conversion platform
For 40 years now, we have been creating content digitally. Documents, spreadsheets, databases, presentations, videos, audio files… We created 2.5 quintillion data bytes every day in 2018. That number is only increasing exponentially and expected to reach 175 zettabytes of data in the global datasphere by 2025.
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Much of this content will need some form of format conversion at some stage. This can be for various purposes: compliance, standardization, archiving, communication and many more. It can also simply be because the existing file format is no longer supported.
As an example, PDF has become a de facto standard for many outgoing documents, while PDF/A is widely used for archiving.
- We will be presenting our document management learnings from 30 successful implementations.
- The content is focussed on sharing insights, not on a product pitch.
- You walk away with valuable information on how 30 global companies approach enterprise document conversion and how they save big.Â
Generate compliant PDFs for multiple HAs automatically BEFORE publishing eCTD leafs webinar
re you getting ready for your next submission? And interested to simplify and speed up submission content creation? Manipulating and finalizing PDFs using desktop tools is a manual task: embedding fonts, checking hyperlinks, adding ToCs and making sure they comply with HA requirements. And repeating this for 100.000s of documents. All this manual work will only increase your time to market. Today, it does not have to be that way. You can generate FDA, EMA, PMDA (or other HA compliant) compliant PDF renditions before compiling submissions.
- Make sure that the PDFs created are fully compliant with the Health Authority specifications. Fully automated, without user intervention.Â
- Reduce the dependency on manual PDF editing tools to create compliant PDFs.
- Speed up time to market by moving technical content compliance earlier in your regulatory content creation process.
- Save valuable time and drastically reduce risk of non-compliance
Innovative Approaches in Modern Rendering. Reduce Risk, Time and Effort to Ensure HA Compliance
Creating compliant submission-ready PDFs for inclusion in dossiers has proven to be time-consuming, expensive and complex. In this session we share how your peers use modern rendering technology to speed up, reduce the cost of and simplify this process.
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Our special thanks to the Lorenz team for having us at their Lorenz Connect online event.
Save time & reduce risk of non-compliance
through modern rendering
Are you getting ready for your next submission? No matter what publishing tool you are using, you can always save time, ease compliance and reduce risk with modern rendering technology.
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After watching the recording of this 30-minute webinar, you are able to:
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- Assess how your current process of preparing compliant output for regulatory submission
stacks up with your peers in the industry. - Understand how creating fully technically compliant output earlier in the submission process will positively impact your submission preparation.
- Walk away with practical, easy-to-implement suggestions for improvement.
We are busy planning our next webinars. Check back again in a few days, you will see them on this page.
How to save time and reduce risk by fully automating the creation of your reports
Are you creating your reports manually today? Or perhaps using complex submission publishing tools to build your reports? Investigational medicinal product dossiers (IMPD), clinical study reports (CSR), annual reports, training manuals, standard operating procedures (SOP) and even full 510k & PMA submissions could all benefit from a tool designed specifically for their creation.
Merging multiple documents into 1 or more PDFs, manually adding cover pages, including tables of contents, applying headers & footers that incorporate consistent pagination across the entire report and ensuring the final output doesn’t exceed any regulatory filesize limits is a time-consuming manual process for many. It often requires separate teams of people, or eats up valuable time from others.Â
The manual work required, and the complexity of the tools used today, make report publishing a very time-consuming and expensive task.Â
Today, report publishing can be fully automated.Â
Join Paul Ireland in this 30 minute webinar to discover how you can easily:Â
- Simplify your report publishing process:
- Merge or split multiple documents, add cover pages and tables of contents, apply consistent headers and footers, paginate, and ensure complete sets of bookmarks and working hyperlinks are included.
- Eliminate manual steps from your report creation process
- Significantly speed up your process by automating the creation of reports from ZIP files, Documentum Virtual Documents, Veeva Binders or entire folder structuresÂ
- Generate reports that are fully technically compliant with any health authority’s requirements and ready to be used separately or included in your submissions.
Looking forward to seeing you in our webinar on June 9th.
Key Learnings
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- Discover how to implement a proven report publishing solution for pharmaceutical, biotech and medical device companies
- Â Learn about the software that automates, accelerates and simplifies the way you create reports; no matter which system your source documents reside in
- Â Enrich your knowledge on the report publishing process, from the technological and workflow perspectives
How to accelerate content preparation for regulatory submissions.
A case study by Pharmalex.
Regulatory submissions are one of the most critical milestones for Life Sciences organizations and can consist of thousands of documents. Submitting on time and in full compliance with Regulatory Agencies’ requirements remains a challenge for many companies.
Today, many Life Sciences companies still struggle with their submission content preparation; manual steps involved introduce risks and slow down submissions.
Fully automating your content preparation for regulatory submissions is possible.
Join our webinar, and discover how you can accelerate your submission content preparation.
Jennie May, Director, Regulatory Informatics and Operations at PharmaLex, a global solution provider, will also explain how they have simplified this process at PharmaLex for their global customers.Â
Key Learnings
Â
- Discover how to implement a proven document conversion and validation solution for pharmaceutical, biotech and medical device companies
- Â Learn about the software that automates, accelerates and simplifies the way to create submission-ready PDFs from original source documents; no matter which system these documents reside in
- Â Enrich your knowledge on how to streamline the eCTD publishing process, from the technological and workflow perspectives
Regulatory Submissions, Information, and Document Management Forum (DIA RSIDM 2022)
The Forum presents four tracks: Regulatory Informatics Business, Regulatory Informatics Technology, Electronic Document Management, and Electronic Regulatory Submissions. Cross-track sessions provide the opportunity to discuss key connection points across major components of regulatory information, and plenary sessions featuring regulatory intelligence updates by FDA and other regulatory authorities are offered each day.
This Forum provides multiple opportunities for networking, knowledge sharing, and education for both business and technology-focused attendees.
Get more information on DIA RSIDM’s official website.
Paul Ireland (VP Life Sciences @DocShifter) is going to be speaking at the DIA RSIDM conference on Lessons learned on Document Preparation & Exchange. You can follow the session on 16 February 2022 from 8:30 AM until 9:45 AM. More details about the session can be found on DIA RSIDM’s website.
LORENZ Connect
Hybrid Event
LORENZ Connect offers information about the latest trends in regulatory affairs and makes demonstrations of our solutions accessible to anyone who is interested in keeping up-to-date.
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LORENZ Connect is an online event for everyone in the regulatory affairs world: The two days will focus on different regional aspects and are being streamed live for different time zones. This way, every participant can find a convenient time to follow the topics that interest them most.
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Paul Ireland, VP Life Sciences at DocShifter, is going to talk about how companies can achieve technical document compliance way earlier in their submission process by automatically checking and fixing all Word and PDF content. Looking forward to seeing you there!Â
