Our VP of Life Sciences, Paul Ireland, was at the TOPRA 2018 Symposium in Stockholm, Sweden from October 1st – 3rd to hear and discuss the latest news and initiatives within the pharmaceutical industry together with Life Sciences regulatory professionals from Europe and around the world. Due to the wide-ranging ongoing initiatives within the regulatory space across all divisions of Life Sciences, the conference was split into multiple tracks:
- Human medicines
- Medical devices
- Veterinary medicines
From the initial introduction by Lynda Wight from TOPRA, it was clear that the topic of Brexit would have a role in many of the discussions during the three day agenda. Read more
Exit Brexit? Our 5 takeaways from TOPRA 2018
/0 Comments/in Blog /by Paul IrelandOur VP of Life Sciences, Paul Ireland, was at the TOPRA 2018 Symposium in Stockholm, Sweden from October 1st – 3rd to hear and discuss the latest news and initiatives within the pharmaceutical industry together with Life Sciences regulatory professionals from Europe and around the world. Due to the wide-ranging ongoing initiatives within the regulatory space across all divisions of Life Sciences, the conference was split into multiple tracks:
From the initial introduction by Lynda Wight from TOPRA, it was clear that the topic of Brexit would have a role in many of the discussions during the three day agenda. Read more
6 Rocking Reasons to Rethink Rendering
/0 Comments/in Blog /by Geert Van PeteghemWe have been converting divergent documents into a unified format such as PDF for many years now. For many reasons.
In knowledge-driven industries, the need for standardization is often highly motivated by regulators. For example, in Life Sciences, the introduction of the electronic Common Technical Document (eCTD) has accelerated the move from paper to electronic formats. In other industries, archiving needs have led to massive content transformation as well. Transformation to de facto standards such as PDF/A ensures that documents are secure for the long term. Read more
5 steps to reduce risks from your current correspondence tracking solution
/0 Comments/in Blog /by Paul IrelandLife Sciences organizations face many challenges when tracking all of the communication that takes place between themselves and other external organizations and health authorities that they deal with on a regular basis. An essential part of any complete Regulatory Information Management (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 that is sent from a health authority for more information, and it is critical that these requests are traceable alongside the tracked regulatory activities in the RIM platform. Read more
6 good reasons why leading Life Sciences companies are rethinking their content rendering solution
/0 Comments/in Blog /by Gaëlle DhaenensWe 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
Network with us at the TOPRA healthcare regulatory affairs conference 2018
/0 Comments/in News /by Gaëlle DhaenensThe 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
Visit us at Digital First 2018
/0 Comments/in News /by Gaëlle DhaenensThanks to more than 10 years of experience, Digital First has been recognized as the leading digital event in Belgium that connects digital leaders. As the market continues to grow, disruption arrives from all angles, and to stay ahead of the game, Digital First will take place over 2 days! Read more
Expansion to Japan thanks to eSA partnership
/0 Comments/in News /by Gaëlle DhaenensIn recent years, the Life Sciences industry has been moving regulatory activities from paper based processes to fully digital. During this shift, they are facing enormous challenges to comply with the increasingly complex regulatory environment as more and more of the world adopts the fully electronic eCTD submission and other fully electronic formats. Read more
Strator recommends DocShifter because of attractive ROI
/0 Comments/in Blog /by Gaëlle DhaenensOur partner Strator helps companies with everything to do with documents, with a wide range of hand-picked technologies, deep business understanding and long experience. They work in any industry but Life Sciences is by far their most dominating market and experience. Read more
What to do with Legacy Data?
/0 Comments/in Blog /by Geert Van PeteghemMany companies sit on a big pile of old data or use outdated systems to manage certain company information. These legacy data and applications might still be valuable to the organization, but their inefficiency, poor usability and high maintenance cost do not weigh up against the benefits. To get the most out of your legacy data you should convert these files to new file formats to keep them accessible, readable and searchable in the long term. Read more
What are the key disruptors for Life Sciences in 2018?
/0 Comments/in Blog /by Geert Van Peteghem2017 has been rife with activity in the Life Sciences sphere. But now, 2018 has begun, and, as would be customary, it is time to move on from the past, and to look forward to what this next year will bring. 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