Life Science Regulatory Intelligence and Strategy Conference

October 18-19, 2018 | Alexandria, VA

Sheraton Suites Old Town Alexandria

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DAY TWO | FRIDAY, OCTOBER 19

8:00 REGISTRATION & WELCOME COFFEE

8:30 CHAIRPERSON’S OPENING REMARKS
Natalia Shunmugan, Director of Global Regulatory Intelligence & Policy, ULTRAGENYX PHARMACEUTICAL INC.

 

8:45 REGULATORY INTELLIGENCE + THE DRIVE TOWARDS INNOVATIVE TRIAL DESIGN
As the FDA’s support of innovative clinical trial design and execution continues to expand, life science organizations are eager to utilize new styles of clinical research in order to secure new product approvals as well as expand existing label indications. Opportunities such as FDA pilot programs, model informed drug development, and the use of simulations in trial design all offer unique benefits previously unavailable to life science corporations. Regulatory intelligence exec¬utives must consider not only current initiatives at FDA as related to trial design but also consider the future impact on clinical research, which will be explored in this masterclass presentation.

  • Competitor regulatory intelligence on trial design
  • Interaction with clinical teams on new regulations
  • Policy feedback and inquiries from clinical operations

Torrey Cope, Partner, SIDLEY AUSTIN

 

9:30 CASE STUDY: STRATEGIES TO MONITOR THE REGULATORY LANDSCAPE AND ENSURE CONTINUED COMPLIANCE
With many organizations operating on a global scale, regulatory intelligence exec¬utives are expressing growing concern surrounding best practices for monitoring the changing landscape to reduce overall risk and ensure continued compliance. To accurately monitor the landscape, intelligence teams follow strategies that allow the opportunity to track policy changes, trends in industry non-compliance issues, both inside the US and internationally, in the most time and resource effective manner. Reviewing innovative strategies to monitor the continually changing landscape will showcase best practices to update internal procedures and position intelligence teams at the forefront of regulatory developments.

  • Updates to current regulatory requirements
  • Emerging policies affecting regulatory intelligence
  • Monitoring on a national and global scale

Teresa Sowinski, Senior Regulatory Intelligence Specialist, IMPAX LABORATORIES

 

10:15 COFFEE & NETWORKING BREAK

 

TWO PART COMBINATION PRODUCTS MODULE
Combination products present a unique regulatory challenge, given the need for safety and effectiveness testing and approval for multiple mechanisms by differing regulatory agencies within the FDA. Regulatory intelligence executives must consider divergent pathways, data requirements and approval channels for these unique products, and in particular, focus on classification and agency assignment. Further challenges include preparing for submissions as well as postmarket safety reporting of combination products, which requires specialist knowledge and care.

10:45 PART ONE: INTERAGENCY COLLABORATION & GUIDANCE ON COMBINATION PRODUCT APPROVAL

  • Classification & assignment guidance documents
  • Interpretation of combination product classification
  • Post-market safety considerations & monitoring

Ana Ladino, Director of Regulatory Affairs, WEST PHARMACEUTICAL SERVICES

 

11:30 PART TWO: INDUSTRY CASE STUDY: IMPACT OF REGULATORY INTELLIGENCE ON COMBINATION PRODUCT CLEARANCE

  • Strategies for monitoring dual-indication regulations
  • Clarification on industry interpretation of guidance
  • Lessons learned from recent product approvals

Darin Oppenheimer, Executive Director, Head Drug Device Center of Excellence, MERCK

 

12:15 LUNCHEON FOR ALL PARTICIPANTS

 

1:15 CASE STUDY: LEVERAGING REGULATORY INTELLIGENCE AND STRATEGY TO SUPPORT PRODUCT APPROVAL
A core aspect of the regulatory intelligence function is supporting life science organizations with the knowledge required in order to create regulatory certainty, ensuring product approvals are obtained in the most efficient manner, maintaining the competitiveness of the organization in the industry. Reviewing best practices to implement findings from past experiences, competitor regulatory intelligence, and results from pilot programs and guidance from regulatory bodies will provide intelligence teams with ample information to ensure rapid approval. A step-by-step review of rapid product approval will demonstrate the process to track findings and align information for a more seamless and faster time to market procedure.

  • Learning from past experiences to mitigate future mistakes
  • Reviewing competitive landscape for product approvals
  • Analysis of pilot programs and guidance to affect approvals

Natalia Shunmugan, Director of Global Regulatory Intelligence & Policy, ULTRAGENYX PHARMACEUTICAL INC.

 

2:00 CASE STUDY: REGULATORY INTELLIGENCE TOOLS OF THE TRADE

  • Software tools available streamline regulatory intelligence
  • Data visualization technology for clarifying changes
  • Variability in tools based on internal resources

Charles Celeste, Director, Regulatory Policy & Intelligence, LEO PHARMA

 

2:45 REGULATORY INTELLEGENCE DISTRUBUTION METHODOLOGIES TO INFORM AND TRAIN INTERNAL STAKEHOLDERS ON POLICIES AND CURRENT COMPLIANCE GUIDELINES
To ensure companywide understanding of policies and continued compliance, regulatory intelligence executives must create training programs and initiatives to effectively communicate with internal stakeholders. Many regulatory intelligence leaders find it difficult to decide the best methodologies of delivering information, such as newsletters, webinars, videos, or white papers, to teams and seek creative approaches to disperse material relevant to specific stakeholders. A review of unique and innovative mediums to best inform internal stakeholders as well as follow up initiatives to determine the level of effectiveness of training will arm regulatory intelligence executives with procedures to implement internally.

  • Effective mediums to best deliver regulatory information
  • Internal support and external partnerships to develop material
  • Determining lasting effectiveness of stakeholder training

Daanish Ashraf , Regulatory Intelligence Lead, BIOGEN

 

3:30 CLOSING REMARKS & CONFERENCE CONCLUSION

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