Meet the Expert
From automation advancements to new regulations, the pharmacovigilance landscape is always evolving. These changes are the focus of Robert Kelle, Senior Director of Safety Strategy, who tackles the future of pharmacovigilance by bringing together industry experts today.
Meet Robert Kelle and learn how he advances drug safety innovation through collaboration.
With more than 26 years of technology industry experience, Kelle uses both online and face-to-face opportunities to build the Oracle safety community. His background as a CIO and technology consultant supports his management of broad thought leadership topics as well as specific product strategy discussions.
Collaboration within the Safety Consortium
Founded in 2019, the Oracle Safety Consortium is the official community for Argus, Empirica, and Safety One and a framework for Oracle to collaborate with both customers and non-customers.
As head of the consortium, Kelle fosters dialogue through online exchanges, such as General Assembly meetings – monthly forums on the latest topics in pharmacovigilance, as well as Oracle’s product strategy and roadmap updates.
For deeper dives into key topics, working groups are led by safety experts, such as product management directors Una Kessi, who runs the Regulatory and Audits Working Group, and Robert Weber, who runs the Signal Detection and Management Working Group.
Advancing pharmacovigilance at Safety Innovation Summits
While virtual forums are convenient ways to stay on the pulse of safety, nothing beats face-to-face collaboration. To meet this need, the consortium hosts biannual Safety Innovation Summits – where leaders in pharmacovigilance come together in-person to drive innovation forward.
At European and North American sites, the summits provide an opportunity for pharmacovigilance professionals to network with peers while learning the latest on safety through panels, presentations, workshops, and more.
Safety Innovation Summit North America 2024
On February 8th and 9th, the 2024 Safety Innovation Summit North America will be held in Reston, VA at the Oracle campus.
This summit will cover topics such as AI in safety, Oracle Cloud Infrastructure (OCI) for life sciences, Oracle product strategy and roadmaps, and new safety regulatory requirements on the global scale.
· Who: All pharmacovigilance and safety professionals, including VPs and QPPVs of safety, case processing specialists, safety evaluators, safety IT professionals, safety managers, Oracle customers and non-customers
· When: Feb. 8th and 9th, 2024
· Where: Oracle Reston office, in-person only
· Admission: FREE with registration approval
Register your interest in attending at Oracle Safety Consortium Innovation Summit - North America.
To learn more about the Safety Consortium, visit Oracle Safety Consortium.
Are you ready to boost your knowledge in the most relevant Clinical One topics? We're happy to announce our upcoming live complimentary online courses for November 2023!
We believe in the power of continuous learning. That's why we've designed four distinct learning paths to fit to your interests and aspirations.
1. Data Collection Learning Path (Nov. 7th - 14th) This Learning Path comprises the following courses:
- Setup for Success (Nov. 7th)
- Form Design 1 (Nov. 8th)
- Visits and Branches (Nov. 9th)
- Form Design 2 (Nov. 13th)
- Rules (Nov. 14th)
This path is perfect for those looking to gather and manage data effectively. Don't miss out on this opportunity to level up your data collection skills!
2. RTSM Learning Path (Nov. 15th - 17th) Ready to explore the world of Randomization and Trial Supply Management? This Path includes the following courses:
- RTSM 1 (Nov. 15th)
- RTSM 2 (Nov. 16th)
- RTSM 3 (Nov. 17th)
Join us to become an RTSM expert!
3. Analytics Learning Path (Nov. 28th - Nov. 29th) Unlock the power of data analysis with our Analytics Learning Path, which includes two comprehensive courses:
- Analytics 1 (Nov. 28th)
- Analytics 2 (Nov. 29th)
These courses will equip you with the tools you need to make data-driven decisions.
4. CRA Essentials Courses (Nov. 8th and 15th) explore how Clinical Research Associates (CRA) play a key role in conducting and monitoring clinical trials. Three courses will be offered throughout the month:
- CRA Essentials (Nov. 8th)
- CRA Essentials (Nov. 15th)
These courses will equip you to determine if sites are following: Study Protocols, Amendments, Good Clinical Practice (GCP Guidelines), and applicable regulatory requirements.
How to Register:
- Visit our website at https://mylearn.oracle.com/ou/live-event-schedule/Oracle%20University/100051
- Log in to your account or sign up for free.
- Click on "Session Details" in the row of the course you want to enroll in.
- Click the "Enroll" button located in the upper right corner of the screen.
- Repeat this process for all the courses in which you want to enroll.
For more information, please refer to this post.
Upon successful completion of each course, you'll receive a free certificate to showcase your expertise.
See you in class!
Did you know that you can access/download the Clinical One Training Report to show all User Clinical One training completion?
Go to the Clinical One Homepage. Click the Study Name and then click the Reports & Archive button.
In the Reports tab click Clinical One Training then enter Settings information. Click Run Report.
Courses (as well as learning paths) are not automatically marked as completed in Oracle University, even if you have successfully completed an enablement course and obtained a certificate.
Below, you will find the steps that we recommend in order to mark a course (and learning path) as completed in Oracle University. This workflow is actually the recommended approach for taking our courses. However, please note that these steps are not mandatory in order to receive your certificate. The benefit of this process is that it allows you to test your knowledge through an online assessment and also receive a badge that you can share on your social networks.
First, access the Life Sciences learning subscription by clicking here. Make sure to sing in using your Oracle SSO.
Next, filter by learning paths by checking the corresponding box:
Then, click on the Learning Path you’re interested in completing.:
Next, click on the course you wish to complete:
On the right-hand side of the screen, you will find a playlist containing the items that make up the course. Typically, this includes a Live Event and a Reference document:
To achieve 100% completion of the course, it is recommended to start by clicking on the Live Event item. In the center of the screen, you will see the text "Please sign up!" which prompts you to sign up for the course. To do so, click on the button "View content":
You will be directed to the schedule of the Life Sciences Learning Subscription. Here, locate the course you wish to enroll in and complete. Then, click on the "Session Details" button:
A new screen will appear. Here you will find a description of the course and other relevant information. To enroll in the course, simply click the "Enroll" button:
After completing the course, it is recommended to access the reference material to label it as completed. To do so, return to the Life Sciences Learning Subscription in Oracle University and access the Learning Path to which this course belongs. You will notice that the course you enrolled in already shows a 50% completion. Please note that this completion percentage is based on assumption and not actual tracking of the Live Session. It is your responsibility to actually complete the session. Click on the course to access its playlist:
You will notice that the item "Live Event" is now highlighted in green.
Next, click on the "Reference" item:
You will see a "View content" button in the center of the screen. Click on it to access the reference material:
A new tab will open, displaying the reference material for this course. At this point, the system assumes that you have studied this material. It is your responsibility to go through it and study it:
If you go back to the course playlist, you will see that the reference item is now highlighted in green:
If you return to the list of courses that make up the learning path, you will notice that the course now shows a completion of 100%:
Our suggestion is to sign up and attend all the courses in the learning path, and also study the reference materials available for each course. After doing so, all the courses in the learning path will be labeled as completed.
Next, you will have the opportunity to test your knowledge by taking an online assessment. To do so, click on the assessment item:
Next, you will see a pop-up message like the one below. Click on "start" to begin the assessment. You will need to answer at least 80% of the questions correctly in order to pass and receive your badge:
There will be a variety of question types, such as multiple choice, true or false, etc:
If you pass the assessment, you will see a screen similar to this:
You will then see a congratulations message and have the option to view your badge or share it on your social networks:
And that's all there is to it! We hope this post has been helpful to you. Please feel free to leave any comments or questions below.
Here are some other topics that you might find interesting:
Data Managers, you can help us build future offerings! We need your feedback!
Your Clinical One Enablement team would like to create future enablement offerings specifically focused on the needs of Data Managers. WE WELCOME YOUR FEEDBACK!
Please take 15 seconds to complete a three-question survey to help us get started. We appreciate your time and participation and look forward to continuing to work closely with you in the future!