Regulatory Information Management Systems Conference

DAY ONE | TUESDAY, JANUARY 14

8:00 REGISTRATION & WELCOME COFFEE

8:45 CHAIRPERSON’S OPENING REMARKS

9:00 OPENING ICE BREAKER: EXPLORING THE DEFINITION & EXPECTATIONS OF RIM SYSTEMS TO ALIGN WITH A GROWING MARKET
When implementing RIM systems, executives are tasked with providing insights on internal adoption timelines and customizing the parameters for RIMS across the company. Given the need to maximize on the system’s capabilities, audience members will join a live poll in order to collaborate on major trends in RIM implementation, definitions, and parameters. Participants will also be given the opportunity to build contacts with industry peers, kicking off the event networking platform.

9:30 THE EVOLUTION OF RIM SYSTEMS AND THE REGULATORY INFORMATION MANAGER ROLE
The last decade has seen the rapid advancement of RIM systems, due in part to technological progress and the demands of an increasingly regulated environment. Systems which started as single-function platforms have evolved into suites of sophisticated products, able to assist tasks ranging from product registration and document management to complex submissions and publishing. Paralleling this growth is the expansion of the responsibilities within the regulatory information manager role, a position which has become distinct from regulatory operations and submissions by purely focusing on the collection, improvement, archival, and dynamic use of the vast amounts of regulatory data generated by life science companies. This industry overview will explore the essential responsibilities, limitations, and exciting trajectory of this growing field.

• Workplace trends and difficulties
• Survey of new innovations and tools
• Perspectives on RIM team staffing

Sonja Justice, Director/Head, Global Regulatory Affairs Operations, AMICUS THERAPEUTICS

10:15 INSTIGATING FACTORS IN THE TRANSITION FROM MANUAL PROCESSES TO A RIMS
While working without a RIMS can be sustainable in certain contexts, events such as expansion into global markets, new drug or device development, and organizational restructuring often provides an impetus for switching to a RIMS—a transition that requires a great deal of time and preparation to execute effectively. By anticipating the need for RIMS implementation well in advance, executives can schedule the transition during times of reduced company activity, perform a robust needs assessment in order to select a viable system, and take early steps to prepare data for migration.

Richard Fredericks, Director, Regulatory Systems and Information Management, TESARO BIO

11:00 COFFEE & NETWORKING BREAK

11:30 PANEL: DEVELOPMENT OF CRITERIA FOR THE SELECTION OF A RIMS

• Selecting individual RIMS modules based on current needs
• Ensuring RIMS scalability matches planned company growth
• Level of available vendor support
  • During deployment and implementation
  • Ongoing user support
• Forecasting expenditures beyond initial purchase

PANELISTS:
Marc Stern, EAGLE PHARMACEUTICALS

Stephen Amato, NORTHEASTERN UNIVERSITY

Danielle Beaulieu, BRISTOL-MYERS SQUIBB

12:15 LUNCHEON FOR ALL PARTICIPANTS

1:45 PANEL: PREPARATION PARAMETERS FOR EXECUTING A SEAMLESS RIMS INTEGRATION

• Clear definition of timelines, roles and responsibilities
• Development of contingency plans for unexpected obstacles
• Authoring and training on standard operating procedures
• Strategies for overcoming staff resistance to new technology

PANELISTS: Sonja Justice, AMICUS THERAPEUTICS

Ruth Hatfield, FLEXION THERAPEUTICS

2:30 MODULE: RIMS CHALLENGES AND SOLUTIONS BASED ON COMPANY SIZE
The specific challenges faced by regulatory information management executives, as well as the varied strategies for overcoming them, are often determined and informed by company size. Larger companies may encounter difficulties in implementation initiatives involving a significant number of users, such as change management, lack of user buy-in and inconsistent system use, while smaller companies face issues rooted in ROI concerns or personnel limitations. Groups stratified by company size will deep dive into both the expected and unique challenges faced by colleagues, as well as creative solutions currently being employed across the industry.

INTRO: Jacob Song, I-MAB BIOPHARMA

GROUP 1: Marc Stern, EAGLE PHARMACEUTICALS

GROUP 2: Thilak Thandapani, MEDIMMUNE

GROUP 3: Lisa Doyle, JANSSEN

3:45 COFFEE & NETWORKING BREAK

4:15 CASE STUDY: ESTABLISHING AUTHORIZATION LEVELS & ACCESS CONTROLS WITHIN RIM SYSTEMS
In the early stages of RIMS adoption, maintaining data integrity is simplified by the fact that input can be filtered through a small number of specialized information management executives. Increases in RIMS utilization may necessitate the addition of new users, expanding the system’s capabilities but also exponentially increasing the potential for system input errors. To mitigate this risk, companies must take precautions when training and hiring new system operators, working meticulously to establish standard operating procedures and proper levels of access to safeguard data integrity.

• Determining internal access to RIM systems
• Creating tiered levels of access for users
  • Identifying system administrators
  • Setting dynamic access controls
• Tracking RIM data updates & system changes

Thilak Thandapani, Lead Document Management Specialist, MEDIMMUNE

5:00 END OF DAY ONE CONFERENCE

6:00 GROUP DINNER
Q1 has arranged for a group reservation at a nearby restaurant (T.J. Stones), located a short walk from the hotel. This dinner is not sponsored by Q1 or any supplier partner and is open to any participant looking to have an evening out and get to know other attendees. Please let a staff member know if you’d like more information or to join the group!