We will be exhibiting at the this year’s DIA Regulatory Submissions, Information, and Document Management (RSIDM) Forum. Senior Amplexor executives will be available to explore some of the industry’s most pressing questions. The Forum features four tracks: Regulatory...
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IDMP
5 Major Efficiency Boosts for Your Regulatory Operations
A modern, holistic, end-to-end regulatory information management (RIM) system can help to greatly improve the efficiency of regulatory data, content and process management, deliver substantial cost savings, and enhance the quality of final output. Without a modern...
Visit us at TOPRA 2022
We will exhibit at the forthcoming TOPRA Annual Symposium in Vienna on 17-19 October. The Symposium, which encompasses human pharmaceuticals, medical devices/IVDs and veterinary medicines, brings together key regulatory professionals from big pharma, small and...
Visit us at DIA 2022 Global Annual Meeting
For the first time in several years, the DIA 2022 Global Annual Meeting returns in-person, bringing industry professionals, regulators, academics and patients together to co-create, problem-solve and discuss global and local challenges facing professionals in the life...
Duplicated document & data creation must stop!
Although the value of developing more data-driven processes is now widely recognized, many life sciences organizations today still routinely create critical documents and product labeling from scratch. This involves capturing and applying the same information repeatedly, yet often in different formats and using inconsistent terminology.
IDMP SPOR: Argh! So much is changing – now what?
EMA’s latest shift in its IDMP implementation guidance has been well documented. At the coal face, it’s causing all kinds of confusion as pharma companies try to figure out what they should do now. At Amplexor BE THE EXPERT 2022, K2 Consulting’s Kelly Hnat will draw on her ‘insider’ knowledge as an active participant in the EMA SPOR Task Force and member of the EMA PMS Process Focus Group, to provide some welcome clarity.
5 essential IDMP readiness checkpoints for your future-proof RIM platform
GPRAS BERLIN CONFERENCE5 Essential IDMP Readiness Checkpoints for your Future-Proof RIM platformWatch this insightful presentation Renato Rjavec delivered at this year's GPRAS conference in Berlin and learn what 5 key aspects pharma companies should consider when...
Amplexor Life Sciences’ annual Be The Expert conference
Amplexor Life Sciences’ annual BE THE EXPERT conference brings together leading global subject matter experts to explore the latest trends in IDMP, RIM, Labelling and Quality. We are happy to unveil the agenda for the upcoming Be The Expert conference, a virtual...
EU IDMP Implementation: DADI and the agile way forward
WEBINAR ON DEMANDEU IDMP Implementation: DADI and the agile way forward Beginning of this year, European Medicines Agency (EMA) has finally broken cover and publicly confirmed the closed circle information and rumors spreading in the previous months: the DADI...
The big DADI switch: EMA’s 11th-hour IDMP rethink and what it means for data-based regulatory submissions
Learn more about the latest EMA’s IDMP rethink and how that will affect data-based regulatory submissions.
Now that IDMP is real, is your RIM roadmap on the right track?
Becoming ‘IDMP ready’ is a marathon, not a sprint: the most important factor for compliance is being on the right path. So what’s your starting point?
EU IDMP implementation kicks off
On 22nd February 2021, the long-anticipated moment happened: the European Medicines Agency (EMA) has published the EU IDMP Implementation Guide version 2.