Agenda at a Glance
Monday, August 24, 2020
10:45 am EDT
- Discuss the importance of change management and how successful system and process adoption is achievable.
- Understand how missed data quality, cleansing and metadata opportunities can negatively affect your organization in the future.
- Ensure processes are streamlined, harmonized and aligned to gain efficiencies.
- Review the importance of developing and implementing a strategic plan that will allow your organization to gain optimization during your system implementations.
Director of R&D Systems Exchange
11:30 am EDT
- Build empowering relationships with international regulators and boards of health for supportive partnerships
- Establish country-specific offices and overcome cultural barriers
- Break down team silos and institutionalize product knowledge to tackle issues of high importance
- Streamline both upstream and downstream communication lines to maximize submissions capabilities
Senior Submissions and Project Manager
PRA Health Sciences (Formerly with Pfizer)
12:15 pm EDT
12:30 pm EDT
- Update your RIMS with another layer for global registries
- Overview of the business case to adopt the technology and roll-out plan
- Develop SOPs and guidelines for the end users after UAT testing
- Ensure the automation process is fully functional and all users are trained on the new processes
Director/Head, Global Regulatory Affairs Operations
1:00 pm EDT
Increases in RIMS utilization and many cases the globalization may necessitate the addition of new users, global access, expanding the system’s capabilities but also exponentially increasing the potential for system input errors and data security control needs. To mitigate this risk and protect intellectual properties(IP), companies must take precautions when training and hiring new system operators, working meticulously to establish well managed access control methods, standard operating procedures and tracking RIM data updates and system changes.
- Creating tiered levels of access for users
- Identifying system administrators
- Setting dynamic access controls
- Determining internal access to RIM systems
- Internal vs External users access management
1:45 pm EDT
2:45 pm EDT
- History is meant to teach, yet how should organizations enable themselves to be ready to learn from their past experiences?
- Key elements of an effective learning organization and defines Knowledge Management Excellence and why you shouldn’t work any other way.
- Challenge the preconceptions around the value of social media and other societal norms within organizations.
- Illustrate how we share and use what is currently known by the complex collection of individual contributors within a corporation and discuss how organizations can harness these individual contributions to establish a collective corporate memory.
Senior Director, Regulatory Affairs Operations
3:30 pm EDT
Monday, August 24, 2020
10:45 am EDT
- Understand the need for a 21 CFR 11 compliant electronic document management system (EDMS) to manage regulatory documentation
- Evaluating the right time to invest in an EDMS and the steps involved in doing so — including the procurement process
- Ensuring a successful implementation and organization-wide roll-out
Director of Regulatory Affairs
Regulatory Documentation Specialist
11:15 am EDT
- Company level of development, pipeline, and five-year plan
- Company existing methods of regulatory information management – manual, vendor-dependent
- Lack of in-house expertise for decision-making, depending on vendor to make strategic decisions
- Rationale for moving to in-house RIM
- Company pipeline
- Definition of RIM for this company
- The Plan
- Parallel RFP for RIM and RDMS
- Budget, Resources, Validation
- Present and Future Plan
Director and Head of Regulatory Operations
Flexion Therapeutics, Inc.
12:00 pm EDT
12:30 pm EDT
“Neo, sooner or later you’re going to realize, just as I did, there’s a difference between knowing the path and walking the path.”
This is a quote from The Matrix, by Morpheus. You may wonder what this has to do with RIMS? In the metaphorical sense quite a bit. Human intelligence (HI) is outcome and purpose focused. HI produces information in multiple contexts to achieve said purposes. Artificial Intelligence (AI) has no goal, meaning or direction on its own unless HI provides it. What if HI turned the Matrix around and paved the path to the future with the help of AI?
We do have the standards, the business context, the insights, but we have not successfully connected it to build the path that all of us want to walk — repeatedly, traceably and reliably. This session will explore real world “what if” scenarios to illustrate the concept and the benefits of a trusted framework for a CMC and Labeling use case.
Document Management Enablement Head
Janssen Research & Development
2:00 pm EDT