Don’t miss your chance to converge, connect and collaborate: Read more about the lead topics at LORENZlink
Posted on February 20, 2020
UPDATE: LORENZ regretfully cancels LORENZlink 2020. Click here to read more.
The LORENZlink 2020 RIM conference is taking place from April 21-22, 2020 in Vancouver, Canada.
Our two-day conference will feature presentations and tutorials by many distinguished LORENZ customers, partners and employees. The agenda includes a range of hot topics from prominent experts. See some highlighted topics below or the whole agenda by clicking here.
After the two-day conference, you can join us for the the optional day (April 23, 2020) of docuBridge training!
Register here for the conference or here for the training day.
Technical Rejection Criteria for Study Data: Are you Ready?
After attending this session, participants will be able to recognize the impact of the FDA's Technical Rejection Criteria for Study Data. They will be equipped to distinguish which studies will be required to submit CDISC compliant data, as well as how to meet validation requirements for those studies that do not.
The FDA released the Technical Rejection Criteria for Study Data, and while they have not yet issued a 90 day notice of implementation, sponsors need to truly understand the requirements and impact this mandate will have. There are two main subcategories for the Technical Rejection Criteria for Study Data: Nonclinical and Clinical data and so understanding the Technical Rejection Criteria can seem daunting; however, it is important to truly understand not only what the FDA is asking, but also how to convey the importance of the message to Nonclinical and Clinical colleagues to ensure applications are compliant and therefore avoid a formal rejection.
Presented by Shannon Heacock, WAYS Pharmaceutical Services
The Next Phase of the RIM Journey, Enterprise Connectivity and Data Structured Submissions
Most Regulatory Organizations have been focusing on modernizing their RIM capabilities bringing higher degree of information visibility, operational efficiency, and data quality. As data standards evolve with new submission requirements, connecting the RIM environment to other functional areas becomes an important next step. This presentation will cover how industry is progressing with these key activities and along with some preliminary findings from the 2020 World Class RIM: Is Industry at a Performance Tipping point benchmark?
Presented by Steve Gens, Gens and Associates
Continuing to Adapt: "The Continued Evolution of Publisher Into Supporting Other Areas of RA and Beyond"
Biogen's Submission Sciences team has been focused on increasing visibility and opportunity for Regulatory Operations to impact the company priorities. Regulatory Operations personal are continuing to develop an increasing skillset beyond that of publishing expertise. This case study will follow Biogen's journey over the past year. Broad ranging topics will be discussed ranging from group re-alignment which maximized synergies to harmonizing skills and processes for a global team. This case study will share Biogen's current evolution along this journey to empower and develop team members, remove obstacles, and show the benefit to Biogen's Global Safety and Regulatory Sciences Organisation.
Presented by Jillian Carinci, Biogen
RA Efficiency through Process Optimization: A Bayer Case Study
"Digitalization" is a key success factor to enhance efficiency in Regulatory Affairs. But what does that mean and how can this be achieved in real life?
At Bayer we are convinced that successful digital transformation in RA requires the combination of advanced technology with optimization of processes.
We launched the "BRAVE" initiative to overcome silos that span functions, processes, IT applications and even underlying data. Join us to hear about how we evaluate our current IT landscape, identify opportunities to work better, and embrace technologies to establish a set of Regulatory Affairs capabilities.
Presented by Barbara Gansewendt, Bayer AG
This entry was posted in LORENZ Events.