Ennov is pleased to announce its sponsorship for the 2022 Global Pharmaceutical Regulatory Affairs Summit (GPRAS) being held in Berlin on April 6-8, 2022. In addition to the on-site event, attendees will be able to view the presentations of this hybrid event virtually from April 11-13.
Attending this summit means the opportunity to meet with the Ennov Regulatory experts. Meet the Ennov team at Booth #7 to discover our regulatory solutions and receive an exclusive copy of our white paper outlining the latest “IDMP Best Practices” or case study exploring how to implement a full regulatory platform in under 12 months. Also, don’t miss the opportunity to get a product demo of the most recent version of our industry-leading RIM offering, recognized by Gens & Associates and Gartner.
On DAY 2 – Thur, 7 Apr 11:15 – 12:00 catch a presentation by Ennov’s Pierre Stanislawski and Maxime Delpire along with Dr. Joerg Stueben from Boehringer Ingelheim:
Leveraging RIM for DADI and IDMP – Theory and Practice
Preparing RIM systems and their evolution in a moving regulatory context is an inevitable concern, both from the Data and the Process point of views. Keeping control over the RIM data model, while ensuring compliance with moving reporting requirements from health authorities, requires appropriate system design and capabilities, as well as a steady governance. Agile methodologies teach us that trying to reach out early for concrete outputs is most effective in the long-term.
· Best practices for RIM Data modeling in the IDMP context
· How can RIM start supporting the DADI process
· Agile FHIR message generation and viewer
GPRAS gathers the pharmaceutical regulatory affairs community, spanning industry, regulators, service providers and solution providers to bring answers to the pharmaceutical industry’s regulatory challenges. RIM, IDMP, eSubmissions, global regulatory markets, and filing variations will be among the topics discussed during the summit.
Ennov is pleased to sponsor this important industry event. Be sure to stop by booth #02 to learn more about Ennov’s unified Regulatory Software Suite that covers Regulatory Document Management, Submission Publishing and Regulatory Information Management that is IDMP-ready.
Headquartered in Paris, with offices in the US, UK, and Asia, Ennov provides the most intuitive, comprehensive, and cost-effective suite of software solutions for the life sciences industry. From leading pharmaceutical companies to emerging biotechnology companies, we proudly serve over 250 companies and 250,000 users around the world. Our solutions are designed and built to support the entire Life Sciences R&D continuum including Clinical, Regulatory, Quality, Pharmacovigilance and Commercial.