Nordic ePharma Day ePharma DayMay 31 | Copenhagen​​​​​​​​​​​​​​​​At the 2017 Nordic ePharma Day, NNIT will be represented by Niels Buch Leander, ​Global Regulatory Affairs Lead at NNIT and ​​Dorte Frejwald Christiansen, Principal Consultant at NNIT. Their shared presentation at the conference will provide insights into how companies can ensure a swift and timely transition to compliance with Clinical Trial Regulation.This year the ePharma Day is focused on the “Implementation of Clinical Trial ​Regulation, EU 536/2014, and national adoption."The new regulation demands substantial and important changes in the methods for conducting clinical trials. As such, the ePharma Day seeks to inform attendees on what lies ahead with the implementation of the EU 536/2014, and provide insights into the associated impacts on clinical trials and stakeholders​.​​The agenda for the conference includes the ​following topics​​Danish regulations and considerations toward the implementation of the Clinical Trial Regulation​Implementation of the Clinical Trial Regulation in Norway​Risk based approach to clinical trial management​Clinical Trial Regulation EU 536/2014, implications for submissions and start-up. Evolution of the sponsor/CRO relationship​​​In order to register for the conference, please follow this link​.About the conference​​​​The ePharma Day is an initiative that aims to provide discussion-events in various European countries concerning issues related to quality compliance as well as with rules, regulation and management of clinical research and drug development​.​​​​ The objective of the conference is to bring people with different perspectives and functions together, in order to share common winning strategies and tools that can be applied across the pharmaceutical industry.Should you wish to learn more about the Nordic ePharma Day or register for the conference, please follow this link​.
Veeva R&D Forum 2017 R&D Forum 2017May 30 – June 1 | Copenhagen​NNIT is sponsor at Veeva European R&D Forum in Copenhagen. Hear about industry trends and best practices for transforming regulated content across clinical, regulatory, quality and manufacturing.Read more...
EU General Data Protection Regulation (GDPR) for Life Sciences General Data Protection Regulation (GDPR) for Life SciencesJune 7 | 3:00-4:00 PM (CEST)​​​​​​​​​​​How to conduct a Privacy Impact Assessment (PIA) that includes processes and systems specific to Life Sciences. The EU General Data Protection Regulation (GDPR) takes effect on May 25, 2018. GDPR requires all private businesses and public authorities to implement sufficient IT security for the protection of personal data processed in the organization, including within the life sciences. As life sciences companies collect and use large amounts of sensitive data, e.g. in clinical trials, the new regulation is particularly relevant for the industry.NNIT has been working within the life sciences for more than a decade, and has conducted more than 20 GDPR impact assessments within the last twelve months. The impact assessments cover the initial risk assessment phase mapping all of the relevant business processes, data types, systems, and external data providers for personal sensitive data. This includes processes pertaining to drug development, regulatory procedures, drug safety, manufacturing, and sales & marketing.Join this webinar to learn more about how GDPR impacts life sciences, including which processes and system types are affected in particular. The webinar will provide an overview of NNIT’s five-phase framework to assist life sciences companies in becoming GDPR compliant.Register for the webinar​ here​AgendaIntroduction to the GDPR regulationExamples of how life sciences processes are impacted by GDPRIntroduction to NNIT’s five-phase framework to support GDPR compliance​​SpeakersThomas Hornbæk Svendsen, Subject Matter Expert, NNITMartin Rother Breyen, Advanced Business Consultant, NNIT​
Implementation of IDMP in small vs. large companies: What are the commonalities and what are the differences of IDMP in small vs. large companies: What are the commonalities and what are the differencesJune 15 | Webinar​​After a period of uncertainty with delayed guidelines and postponed deadlines it is now time to set in with the final stint to prepare the organization to submit and maintain IDMP data by 2019. In this webinar we will take a closer look at some of the challenges related to IDMP implementation and how to approach them in the most optimal way whether you are handling data in a small or in a large life science organization.NNIT has worked extensively with IDMP since 2012 on more than 25 pharmaceutical companies and some national competent authorities.Presenters are Rune Bergendorff and Nikolaj Marsk Andersen from NNIT.​Register here
”Folkemødet” - Denmark’s Political Festival on Bornholm”Folkemødet” - Denmark’s Political Festival on BornholmJune 15-18 | Bornholm​​​​Attend our panel discussions on "IT-Paratskibet" in Allinge. This year we are hosting 3 panel discussions Friday 16 June and Saturday 17 June with focus on digitalization and healthcare. Discussions will be live streamed at or in our NNIT Facebook groupFriday 16 June at 13.30-14.30Saturday 17 June at 12.00-13.00 Saturday 17 June at 15.00-16.00 New digital welfare Hear how the public sector through digitization creates better and more coherent welfare. Join us for an exciting panel discussion with four distinct personalities, each with their views on what the next big steps will be on digitalization of future welfare. Panel participants Lilian Mogensen, Executive Vice President, ATP; Lars Frelle-Petersen, Director, Digitaliseringsstyrelsen; Svend Hartling, Director, Region Hovedstaden and Moderator, Lars Andersen, Vice President, NNIT​Focus on the patient – new healthcare platform"Sundhedsplatformen" is a healthcare platform that assembles information about the individual patient in one common system. It enables easy access to patient health data for the clinical staff and for the patient himself, resulting in improved patient care, more security and better treatment continuity. Panel participants Svend Hartling, Director, Region Hovedstaden; Niels Reichstein Larsen, Hospital Director, Bornholms Hospital, Praktiserende Lægers Organisation (PLO); Moderator, Jan Kold, Vice President, NNIT ​Follow us on LinkedIn NNIT Public & HealthcareOr on Twitter @NNIT #itparatskib #fmdkRead more about "Folkemødet" here​