6TH ANNUAL REGULATORY OPERATIONS AND SUBMISSIONS CONFERENCE

MAY 22-23, 2017 | PHILADELPHIA, PA
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DAY ONE | MONDAY, MAY 22

8:00 REGISTRATION & WELCOME COFFEE

8:50 CHAIRPERSON’S OPENING REMARKS
Heather Sinsel, Manager Regulatory Operations and Submissions
INOVIO PHARMACEUTICALS

 

9:00 PLANNING FOR BUSINESS CONTINUITY WITHIN REGULATORY OPERATIONS
This session will go through the practical considerations of planning for business continuity. Using practical examples, by the end of the session the attendee will understand:

  • The difference between business continuity and disaster recovery and the dependencies between the two
  • How to approach the development of a business continuity plan that addresses the real needs of the organization rather than just the documented plan that sits on the shelf with an example of key areas to address
  • Practical suggestions for keeping the plan relevant, ensuring user awareness, and implementation readiness

Jeanette Glenn, Lead Documentation Specialist, MEDIMMUNE

 

9:45 PANEL DISCUSSION: EXPLORING THE NEXT GENERATION OF REGULATORY OPERATIONS

  • Debate the evolution of required skill sets for role
  • Impact of technology advancements on regulatory teams
  • Advocating regulatory operations as a strategic partner
    • Earlier involvement in decision making
    • More established presence in strategy development
  • Sourcing new talent for regulatory operation teams

LIVE POLLING
This panel discussion will utilize live polling capabilities allowing the audience to be an active participant in the discussion.

Ruth Hatfield, ARIAD PHARMACEUTICALS

Michael Sauter, MALLINCKRODT

Craig Gassman, KARYOPHARM THERAPEUTICS INC

 

10:30 COFFEE AND NETWORKING BREAK

 

11:00 THE FUTURE REGULATORY OPERATIONS PROFESSIONAL: EVALUATING INDUSTRY TRENDS AND DISRUPTIVE TECHNOLOGIES THAT WILL FURTHER SHAPE THE ROLE
The role of regulatory operations both as a functional unit within organizations, and a profession, has evolved drastically over the years. Professionals are typically so busy that they often overlook the mosaic of activities and skills required to continually develop themselves, their teams, and align strategic within their organizations. This session aims to analyze many of those activities through a different lens and provide a unique perspective on the role today, tomorrow and the far future as disruptive technologies loom just over the horizon.

Craig Gassman, Associate Director | Regulatory Operations, KARYOPHARM THERAPEUTICS INC

 

11:45 EXCHANGE GROUP DISCUSSIONS
Exchange group breakout discussions will provide a forum for the sharing of ideas and networking opportunities, which are of high value to regulatory operations experts. Program attendees will break into smaller groups to further ad¬dress important topics affecting the current regulatory operation and submissions environment. All attendees, speakers and sponsors are encouraged to become active participants allowing for better exchange of ideas, peer-to-peer learning, and open discussion.

 

12:15 LUNCHEON FOR ALL ATTENDEES, SPEAKER AND SPONSORS

 

1:45 PANEL DISCUSSION: IMPORTANCE OF COLLABORATION WITH CROSS FUNCTIONAL TEAMS

  • Promoting interoperability between internal stakeholders
  • Outline each teams’ roles, responsibilities and timeline expectations
  • Management structure for cross functional team collaborations
  • Strategies for uninterrupted data sharing across departments

LIVE POLLING
This panel discussion will utilize live polling capabilities allowing the audience to be an active participant in the discussion.

Moderator: Sophia Kourliouros, EISAI, INC.

Panelists:
Arvind Ala, EMD SERONO

Karin Zeh, ZAFGEN

 

2:30 COFFEE AND NETWORKING BREAK

 

3:00 NAVIGATING SYSTEM AND TECHNOLOGY UPGRADES DURING DOSSIER DEVELOPMENT
The development of quality product dossiers is a complex and time-consuming process that requires the use of a multitude of different software, systems and additional technologies in order to produce a compliant submission. As with most technologies, the systems and software utilized within regulatory operations departments are regularly releasing newer versions and upgrades. Whether it is an upgrade to a simple word processing software or an overhaul to the organization’s EDMS, integrating updates while in the midst of submission development can create severe challenges for regulatory operations teams. This case study presentation will highlight the best practices for integrating system upgrades while ensuring the continued quality of product approval dossiers.

Daria Grindstaff, Regulatory Solutions | Operations Center of Excellence, Information Management
PFIZER

 

4:00 CONSIDERATIONS & STRATEGIES FOR GLOBAL SUBMISSIONS MANAGEMENT
Submissions and lessons learned will also be shared, allowing a unique view into how these challenges are overcome making way for effective operational best practices.

  • Global collaboration strategies: Transitioning regional teams into a global unit
  • Effective management of Primary & ‘Rest of World’ (ROW) Submissions
  • Addressing issues related to poor quality documents and hand off deliverables
  • On the Horizon: Preparing for new legislation in the EU – IMDP & Policy 070

Wil Foster, Director, Global Submissions Management, EISAI

 

5:00 COCKTAIL RECEPTION SPONSORED BY

synchrogenix_logo

6:00 DAY ONE CONFERENCE CONCLUSION

 

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