DAY TWO | WEDNESDAY, JANUARY 15
8:30 REGISTRATION & WELCOME COFFEE
9:10 CHAIRPERSON’S OPENING REMARKS
9:15 PANEL DISCUSSION: ESTABLISHING NETWORKS OF ONGOING USER SUPPORT BEYOND RIMS IMPLEMENTATION
The need for user assistance doesn’t cease after the initial implementation of a RIM system, and it is important that companies have support in place to answer questions and resolve issues as long as the system is active. While some vendors provide partial or full ongoing support, many systems are handed over in their entirety, leaving companies with the responsibility of hiring or training personnel to fill this crucial position. In the creation of a RIMS implementation roadmap, executives must take stock of available user support options and take the necessary steps toward an option that aligns best with available resources, whether direct vendor support, an in-house team, or a third party.
- Building a core team of experienced users
- Preparation of team for the addition of new modules
- Anticipating add-on costs for vendor support
- Ensuring company-wide, real-time global assistance
10:00 MEETING COMPANY NEEDS THROUGH ROBUST RIMS CUSTOMIZATION
RIM systems are built with room for customization, allowing executives to precisely tailor a new system to conform to highly specific company requirements and preferences. For efficiency throughout the RIMS lifecycle, it is advantageous for executives to explore both current and future needs in order to choose a system that can accommodate planned changes while immediately meeting short term goals. This inventory of necessary tasks for the system to perform, combined with a roadmap detailing the steps to successful execution and necessary personnel, can lead executives to the creation of a lean, dynamic system, able to meet needs quickly and directly.
- Selecting individual RIMS modules to align with needs
- Validation to mitigate risk added by customization
- Training users on company-specific modifications
David Fisher, Director, Regulatory Information Management, ALLERGAN
10:45 COFFEE & NETWORKING BREAK
11:15 CASE STUDY: IMPACT OF RIMS ON COMPANY CYBERSECURITY CONSIDERATIONS
In today’s information-driven economy, the volume of information within an enterprise continues to grow exponentially, furthering the need for a RIM system to simplify the management and control of data. With a core resource and a wealth of information available in a sole system, companies are at higher risk for lawsuits from regulatory bodies concerning cyber threats and security vulnerability. When implementing RIMS, executives must ensure integrity, confidentiality, and availability of data before reaping the benefits of a one-stop shop for regulatory information. Applying best practices to RIM systems to secure data and avoid breaches will ensure that company records are stored in a safe and effective manner.
Stephen Amato, Department Chair, Professor Global Regulatory Affairs/QA/Advanced Manufacturing
12:00 LUNCHEON FOR ALL PARTICIPANTS
1:00 CASE STUDY: MAINTAINING DATA INTEGRITY IN LINE WITH EXTERNAL AND INTERNAL STANDARDS
To comply with regulations and ease the process of large-scale data management, executives must ensure that the data and metadata being entered into a RIMS is current, verified, and properly formatted. Guidelines for accurate data input originate from both external standards including ISO IMDP and internal standards such as agreed-upon acronyms, spelling, and abbreviations. Through careful monitoring of system input, executives can increase efficiency by preparing data for submission ahead of time, creating easily traceable information paths in the case of audits, and tracking changes to ensure that data stays clean and current.
- Creating internal standards and naming conventions
- Data cleaning challenges during mergers & acquisitions
- Identifying and omitting irrelevant information
Lisa Doyle, Associate Director, Regulatory Information Management, JANSSEN
1:45 FINDING CENTRALIZED SOLUTIONS TO COMMON REGULATORY INFORMATION MANAGEMENT CHALLENGES
This session will begin as an open discussion of the challenges companies currently face in managing validation and regulatory information. With such challenges in mind, the discussion will turn toward the role centralized systems can play in helping regulated industries both manage product data and achieve the ongoing goal of developing quality products, while continuously increasing speed to market. Delegates are encouraged to brainstorm some predominant challenges and bring them to the table.
Jennifer Moore, Business Development Director, MINERVA GROUP
2:30 COFFEE AND NETWORKING BREAK
3:00 GROUP DISCUSSION: UTILIZATION OF RIMS TO CONSOLIDATE REGULATORY DATA & BOOST SPEED TO MARKET
As global health authorities increase expectations surrounding the development and approval of drugs and devices, companies need a single source of authoritative information in order to streamline processes and keep up-to-date with the changing regulatory landscape. Disparate data management methods—often including physical, offline documentation—can prevent quick retrieval of synchronized and verified data, jeopardizing timelines set by health authorities and risking incomplete documentation. RIMS can act as a top layer in unifying management methods, equipping executives to sort and consolidate information more quickly and allowing worldwide employees and partners to easily access current data.
- Establishing RIMS as the central hub connecting additional systems
- Encouraging consistent, company-wide RIMS use among employees
- Use of RIMS on a global scale for worldwide data access and security
3:30 END OF CONFERENCE