8th Annual Pharmaceutical Regulatory Operations and Submissions Conference

June 11-12 | Philadelphia, PA

Renaissance Philadelphia Airport Hotel

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DAY TWO | WEDNESDAY, JUNE 12

8:30 REGISTRATION & WELCOME COFFEE

8:55 CHAIRPERSON’S OPENING REMARKS

9:00 PANEL DISCUSSION: SETTING KEY PERFORMANCE INDICATORS THAT ASSIST WITH THE SUBMISSIONS PROCESS

  • Defining targets that reduce time spent on submissions
    • Define appropriate metrics for tracking submissions
    • Strategizing internal changes that will assist with workflow
  • Comparing data used in KPI’s against company goals
    • Elevate performance through properly allocated resources
    • Manage costs & decrease time through KPI implementation
  • Analyzing efficiency levels of operations teams through KPI data
    • Setting a submission delivery plan that alleviates errors
    • Restructuring operational involvement within submissions
  • Determining optimal points across submissions timelines to insert KPI’s

Jennifer Kehs, PFIZER

Brandy Pyrcz, JANSSEN

EvaMarie Mondovano, GSK

 

10:00 BENEFITS OF EARLY REGULATORY OPERATIONS AND SUBMISSIONS INVOLVEMENT IN THE NEW PRODUCT LIFECYCLE
Navigating areas submissions executives can engage earlier on in the product lifecycle allows teams to influence processes to increase efficiency when producing submission dossiers. Working closely with other internal regulatory teams unifies the strategy for developing submissions and gives executives a comprehensive knowledge of all operations involved up to submission. As the evolvement of the regulatory operations role continues to grow into a strategic function, strengthening the efforts to work cross-functionally and understanding the benefits of early involvement creates a forward approach to submitting new product dossiers.

Jennifer Kehs, Director, Submission Clinical Project Management, PFIZER

 

10:45 COFFEE AND NETWORKING BREAK

 

11:15 WORKSHOP: OPTIMIZATION STRATEGIES FOR HITTING SUBMISSION TIMELINES
Planning for major regulatory filings represents one of the most critical activities for organizations targeting product commercialization. The primary objective of filing on-time has remained the same, but the tools, operational strategy, stakeholders, and best practices have seen much evolution over the past 10 – 15 years. This interactive workshop aims to bring together professionals throughout the industry spanning various organizational size, therapeutic area, and expertise to discuss what works, what doesn’t, and provide insights on developing trends when planning for NDAs, BLAs, and other major filings. This is a great opportunity to share your experiences, meet new colleagues, and fill in knowledge gaps for professional development. The session aims for attendees to acquire various strategies and advice to implement at their own organizations.

  • Strategically adjusting resources across timelines
  • Systems and tools for tracking timeline submissions
  • Unifying timeline objectives cross-functionally
  • Defining and working with submission project management

Craig Gassman, Director, Regulatory Operations, VERICEL CORPORATION

 

12:15 LUNCHEON FOR ALL SPEAKERS, SPONSORS AND ATTENDEES

 

1:15 PANEL DISCUSSION: DECISION PARAMETERS REGARDING IN-HOUSE VS. OUTSOURCING REGULATORY OPERATIONS TEAM DEVELOPMENT
Pharmaceutical and biotechnology companies are challenged with determining how to best structure regulatory operations teams with specific attention to company size, resource level, and the dossier’s status in the submission process. Varying response time rates, last minute dossier changes, the structural impact on submission timelines, and levels of flexibility within project plans are all aspects to consider. Regulatory operations executives will examine the decision making process behind the choice to work with outside vendors versus using in-house operations.

  • Factors to determine whether to build in-house
  • Financial considerations for outsourcing
  • Identifying necessary levels of internal resources

Robin Weitz, PFIZER

Pamela Rizos, MERCK

Kathleen Prehn, LEO PHARMA

Jillian Carinci, BIOGEN

 

2:15 SMALL GROUP BREAK OUT DISCUSSIONS: STAFFING AND RESOURCE ALLOCATION ACROSS REGULATORY OPERATIONS TEAMS
For regulatory operations groups to function at high performance levels, companies must properly staff teams paying close attention to cost control, the resource’s level of demand, and changing priorities from both an industry perspective and that of the individual company. Allocating internal manpower and resources when considering company size at each point of the submission process can assist regulatory operations teams when adapting and managing changes that effect timelines. Regulatory operations and submissions professionals will discuss trends in the decision-making process behind allocation according to available resource levels, adjusting to meet changing demands, and methods to manage limited resources.

GROUP 1: SMALL PHARMA
Romel Montellano, MIRATI THERAPEUTICS

GROUP 2: MID PHARMA
Ron Hanish, MERCK

GROUP 3: LARGE PHARMA
Francis Quinn, PFIZER

 

3:00 COFFEE AND NETWORKING BREAK

 

3:30 GLOBAL APPROACHES TO REGULATORY SUBMISSIONS: MANAGING REGULATORY PATHS TO ACHIEVE MARKET ENTRY
The role of the regulatory operations and submissions executive is increasingly taking on global responsibilities as organizations look to commercialize products around the world and require market authorization in hundreds of countries with unique submission requirements and frameworks. Current areas of particular interest include submitting through eCTD in Asia, the impact of Brexit on EU clearance, as well as evolving markets the Middle East. Maintaining an awareness of ongoing regulatory changes and requirements is of essential importance for submission executives balancing multiple applications as well as providing ongoing documentation to support market access.

  • Strategies for continuous regulatory intelligence monitoring
  • Current countries & regions updating submission formats
  • Opportunities for using software to streamline global updates

Stephen Amato, Faculty Director, Global Regulatory Affairs/Quality Assurance/Advanced Manufacturing Systems
NORTHEASTERN UNIVERSITY

 

4:15 CREATING COMPLIANT SUBMISSION DOSSIERS WITH UPHELD UNDERSTANDING OF GLOBAL REGULATORY INTELLIGENCE STANDARDS
As global regulatory standards evolve it is critical to establish efficient strategies to remain well versed on new global requirements. While navigating an environment of constant change, maintaining relevant knowledge across new global standards work to eliminate potential setbacks throughout the submission timeline. Specific strategies to stay informed on changing requirements throughout the industry increases efficiency across regulatory operations.

  • Strategies maintain knowledge of regulatory standards
  • Efficient methods for continued education
  • Tools to implement for receiving updated standards

Alexis Harper, Global Head of Submission Portfolio Management, UCB

 

5:00 END OF CONFERENCE

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