A Special Thanks to Our Sponsors

Day One Agenda
Wednesday, April 10

8:00   REGISTRATION & WELCOME COFFEE

8:50   CHAIRPERSON’S OPENING REMARKS

9:00   OPENING ICE BREAKER: BUILDING NEW CONTACTS AND SHARING BACKGROUNDS WITHIN THE REGULATORY INTELLIGENCE LANDSCAPE
The opening ice breaker will kick-off the event with an opportunity for all participants to move around the conference room and meet new delegates by engaging in short and targeted discussions. In this interactive session, participants are encouraged to meet with peers from different companies and briefly share insight into professional backgrounds, shedding light on the diversity of profiles in the participating audience and kicking off the program networking platform.

9:45   SMALL GROUP DISCUSSIONS: OUTLINING AND DEBATING KEY ROLES, RESPONSIBILITIES AND APPROACHES TO THE OPTIMAL REG INTEL STRATEGY
• Approaches and components to regulatory intelligence
• Analyzing functions of a regulatory intelligence professional
• Differentiating regulatory information from intelligence
Jemin Dedania, Director, Regulatory Affairs Global Regulatory 
HOGAN LOVELLS

10:15   COFFEE & NETWORKING BREAK

10:45   PANEL DISCUSSION: PRACTICAL STRATEGIES TO BUILD A REGULATORY INTELLIGENCE GROUP FROM SCRATCH
• Steps to maintaining awareness of regulatory changes
• Tactics to providing input to product development teams
• Outlining strategies to establish local market presence
• Collaboration with regional industry thought leaders
• Scoping the cross-functional boundaries and partnerships
Chet Kitchen, MERCK
Brandy Proctor, GSK
Marloes van der Geer, CELEGENCE

11:30   CASE STUDIES: BEST PRACTICES FOR GROWING AND IMPROVING A SUCCESSFUL REGULATORY INTELLIGENCE NETWORK
• Tactics to meeting regulatory market demands
• Steps to working with diverse stakeholders
• Leadership buy-in and team collaboration
• The importance of regional and global colleagues
• Approaches to building relationships and sharing data
Irene Hsieh, Senior Director, Regulatory & Clinical Affairs
EUROIMMUN US
Julia Jiang Wright, Regulatory Intelligence Director
ASTRAZENECA

12:15   LUNCHEON FOR ALL SPEAKERS, SPONSORS & ATTENDEES

1:15   GROUP DISCUSSIONS: REGULATORY GLOBAL TRENDS, CHALLENGES, OPPORTUNITIES, AND VIEWS
In this session, participants will break out into two groups, pharma and medical technology, to discuss a topic of their own relating to regulatory global trends, guidances, and challenges. Participants are encouraged to give their views and discuss with their peers the opportunities and resolutions to these challenges. Discussion may also extent to examining how regulating intelligence adapts to new modalities.
Raya D. Zerger, Senior Staff, Legislative Initiatives, Regulatory Affairs
BECKMAN COULTER

2:00   REGULATORY RUNDOWN: UPDATE ON FDA POLICY AND TRENDS AFFECTING LIFE SCIENCE ORGANIZATIONS
Life science organizations must be aware of and responsive to current policies as well as remain up to date on FDA activities affecting marketed and emerging medical products and company due diligence activities. Understanding these changes and trends are critical to identifying potential risks and opportunities to any organization’s drug development activities, today and tomorrow.
Torrey Cope, Partner
SIDLEY AUSTIN LLP

2:45   COFFEE & NETWORKING BREAK

3:15   EXAMINING THE INTEGRATION OF AI AND AUTOMATED TOOLS INTO REGULATORY INTELLIGENCE OPERATIONS
• Strategies to merge AI and regulatory intelligence
• Understanding how AI:
   » Efficiently blends with regulatory intelligence
   » Streamlines information management
• Synthesizing news alerts and search capability
• Challenges and limitations in AI integration
• Staying compliant with regulatory intelligence
Patricia Sanabria Muñoz, Global Regulatory Intelligence Director
BAXTER
Amenallah Reghimi, Chief Product & Technology Officer
REGASK

4:00   CASE STUDY: DEMONSTRATING THE VALUE AND IMPORTANCE OF REGULATORY INTELLIGENCE TO MANAGEMENT
Regulatory intelligence teams exhibit value through a variety of metrics including number of comments submitted or FDA meetings conducted. Although these are important evaluations, meaningful significance is added when these figures are linked to affecting a final guidance released by the FDA or the organization saving resources due to faster time to market or overall reduced costs.
• Analysis of qualitative vs. quantitative measurements
• Tracking comments to view effect on final guidance
• Demonstrating reduced costs due to collected data
Julia Jiang Wright, Regulatory Intelligence Director
ASTRAZENECA

4:45   Closing Remarks & End of Day 1

Day Two Agenda
Thursday, April 11

8:00   REGISTRATION & COFFEE

8:20   CHAIRPERSON’S OPENING REMARKS

8:30   TOOLS AND TECHNIQUES FOR REGULATORY INTELLIGENCE COLLECTION AND BEYOND
• Assessing traditional data tools for regulatory intelligence
» Review of commonly used industry tools
» Best practices to effectively utilize databases
» Cost analysis of specific industry tools
• Internal templates used to track intelligence and strategy
• Mechanisms to track intelligence beyond new policies
• Comparing methods of tracking US vs global regulations
Kelli Madden, Senior Regulatory Intelligence Specialist
TOLMAR
Annie Madej, Regulatory Intelligence, Product Development Regulatory
GENENTECH INC.

9:15   SMALL GROUP DISCUSSIONS: METHODS TO COLLECT GLOBAL REGULATORY INTELLIGENCE
Global life science organizations face many challenges while reviewing international policies and developing strategy for specific markets, due to unique regional regulatory pathways and constantly evolving landscapes. This peer-to-peer learning session allows participants to exchange concerns and best practices for collecting regulatory intelligence in complex regions, ensuring knowledge share of time and cost-effective methods.
Brad Spring, Global Head of Regulatory Policy and Intelligence
ROCHE DIAGNOSTICS

10:00   COFFEE & NETWORKING BREAK

10:30   HOW REGULATORY INTELLIGENCE CAN PREPARE TEAMS TO SUCCESSFULLY NAVIGATE MERGERS AND ACQUISITIONS
• Assessing corporate structure
• Evaluating regulatory approval process
• Ensuring and maintaining compliance
• Evaluating risks and change
• Best considerations from a regulatory view
Kristi Kung, Partner, Chair – Healthcare Regulatory Practice
DLA PIPER
Bethany Hills, Partner, Vice Chair, FDA Practice
DLA PIPER

11:15   PANEL DISCUSSION: MONITORING GLOBAL TRENDS IN REGULATORY AGENCIES
• Examining how trends may be adopted and globalized
• Understanding the direct impact of pharma legislation
• Strategies to anticipate and prepare for global trends
• Understanding how trends affect business globally
Saiza Elayda, Associate Director, Global Regulatory Policy
MERCK
Irene Hsieh, Senior Director, Regulatory & Clinical Affairs
EUROIMMUN US
Brandy Proctor, US Regulatory Policy, Advocacy & Intelligence
GSK

12:15   LUNCHEON FOR ALL SPEAKERS, SPONSORS & ATTENDEES

1:15   CASE STUDIES: HOW REGULATORY INTELLIGENCE GROUPS USE AI TO PERFORM DUTIES
• Developed databases to filter multiple sources
• Piloted industry machine learning technology
• Ensuring delivery of correct and relevant information
• Possible applications of machine learning technology
• Sharing methods to disseminate data to strategists
• Additional uses of AI to perform duties
Janeen Skutnik-Wilkinson, Director, Regulatory Intelligence and External Engagement
MODERNA
Abraham Gitterman, Senior Associate
ARNOLD & PORTER
Tushar Nitave, Staff Software Engineer
VIVPRO 

2:15   THE USE OF REAL-WORLD EVIDENCE (RWE) AND REAL-WORLD DATA (RWD) IN REGULATORY DECISION MAKING FOR PHARMA AND MEDICAL DEVICES
• Updates on global regulatory RWE frameworks
• General considerations for the use of RWE
• Assessing data relevance and reliability
• Methods for collection and analysis
Bethany Hills, Partner, Vice Chair, FDA Practice
DLA PIPER

3:00   FIRESIDE CHAT: MAKING THE REGULATORY INTELLIGENCE VOICE HEARD AT THE START OF PRODUCT DEVELOPMENT
• How regulatory intelligence drives R&D
• Creating efficiencies in positioning RI to drive R&D
• Steps to ensure new product lines fit current regulations
• Comparing the best structure to ensure a robust position for RI teams:
» Stand-alone department in the company
» Within another department such as R&D or regulatory affairs
• Best practices in connecting with R&D departments to disseminate information
Carla Amstein, Global Head Regulatory Intelligence
ALCON
Felicia Williams, Senior Director, Head of Regulatory Law, Legal
SUN PHARMACEUTICAL

4:00   Closing Remarks & End of Day 2