8 - 10 April 2019
Crowne Plaza Fira Center,
Barcelona, Spain
Direct access to the experts in RIM, eCTD, IDMP & TMF
Thank you to everyone who attended the 2018 eRegulatory Summit!
Stay tuned for 2019...we are working on an even more exciting agenda to ensure the latest updates from the industry's best!
JOIN OUR FREE WEBINAR
Summary:
Managing post-marketing variations is complicated and time-consuming. Veeva is simplifying the process by eliminating information gaps and automating manual tasks.
See how to speed variations by: running an impact assessment; auto-generating your submission plan; using structured data to author documents; and auto-publishing as documents are written.
3 key takeaways:
- Better handle the scale and duration of post-approval product changes.
- Improve visibility and collaboration between headquarters and affiliates.
- Gain visibility into which documents need updating, which documents are missing, what documents were submitted in the past or in other countries.
We can help you along the path to compliance
Global eCTD Management
Optimise global eCTD management by keeping up with SPOR, EU Telematics and global eSubmissions
Regulatory Information Management & IDMP Compliance
Secure your regulatory information management system by perfecting your data through current industry insight
Trial Master File (TMF)
Trial Master File inspection ready. eTMF inspection ready. Outsourcing ready.
Filing Variations
We're catching up with the experts to bring you the best strategies for filing variations. Whether you're new to, returning to or looking for a refresher, this one day workshop will equip you with everything you need.
Filing variation strategies provide regulatory teams with the potential to save significant resources, both in terms of time and money. Hear from leading Industry experts, as they talk about their expectations and check out the latest updates on:
•Implementation of 712/2012
•Filing Variations across the globe
•Best practice for grouping
This is a workshop you won't want to miss..
2018 Influential regulatory speakers and thought leaders
Stats: Connecting the Regulatory Community
200+
100+
60+
What did our 2017 Attendees have to say?
"eSummit is a unique and Great event where I learned and gained significant knowledge that I don't access anywhere else. Also met with colleagues, peers and vendors all in one place obtaining more knowledge and accessing innovations. Strongly recommend the eSummit!"
"It was an enriching experience of attending the eRegulatory Summit, which gave me exposure to the experts from agency, industry and vendors at one platform. The presentations followed by interactions and networking makes it a complete package for the regulatory professionals."
"Very relaxed atmosphere which allowed easy contact to participants, offered room for discussions and building of new relationships."
Become our Event Partner
To discuss how your company can get involved, please contact Michael Dunnet:
Email: Michael.Dunnet@knect365.com
Tel: +44 (0) 20 7017 7870
SOLVE YOUR RIM CHALLENGES WITH UNIFIED RIM
This sponsored content is presented by Veeva
Many European pharmaceutical companies realize they need to get their data in order to comply with health authority standards. Driving change means rethinking regulatory processes and streamlining siloed systems.
The question is how do you get started? Read about the common trends within transformation initiatives and examples of customer success with a unified RIM environment.
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Pharmaceutical Training International | PTI
PTI is a global interactive training partner committed to the personal progression of aspiring life science professionals. We deliver CPD certified training on a wide range of topics including R&D, pre-clinical, clinical, manufacturing, regulatory affairs, pharmacovigilance, biotech, business strategy and soft skills. Our courses are delivered in a variety of formats such as public face-to-face, customised in-house, webinars, eBooks and online academies.