Life Science Regulatory Intelligence & Strategy Conference

A Special Thanks to Our Sponsors

Day One Agenda
Wednesday, February 26

8:00   REGISTRATION AND WELCOME COFFEE

8:50   CHAIRPERSON’S OPENING REMARKS

9:00   AUTONOMOUS REGULATORY INTELLIGENCE – THE FUTURE OF REGULATORY INTELLIGENCE
As regulatory obligations grow more complex, staying compliant can be daunting. In this session, participants will learn how AI / Machine Learning will proactively suggest actions for your specific company and landscape based on new regulatory information.
Caroline Shleifer, Founder and CEO
REGASK
Kelli Madden, Senior Regulatory Intelligence Manager
REGASK

9:45   PANEL DISCUSSION: REGULATORY METHODS TO COLLECT, ANALYZE, AND INTERNALLY DISSEMINATE INFORMATION
• Advanced and usefulness tools for regulatory intelligence
• Gathering data through participation in external groups
          » Trade Associations
          » Professional Associations
• Advanced and usefulness tools for regulatory intelligence
Natalia Shunmugan, ULTRAGENYX 
Scott Thiel, HOLOGIC
Lee O’Brien, ROIVANT

10:30   COFFEE AND NETWORKING BREAK

11:00   PULL THROUGH STRATEGIES: TRANSITIONING INTELLIGENCE INTO ACTIONABLE STRATEGIES
• Assimilating regulations and guidance documents
• Importance of multidisciplinary/cross-functional discussion on regulations
• External engagement and regulatory advocacy
• Translate regulatory intelligence into actionable regulatory strategy
• Case-studies
Meena N. Muthiah, Director, Regulatory Intelligence
ASTRAZENECA

11:40   REGULATORY GLOBAL TRENDS: CHALLENGES AND OPPORTUNITIES
• Changes and challenges with the global strategy perspective
• Understanding initiatives occurring in other countries
• Methods for integrating strategy and intelligence globally
• Practical strategies to anticipate and prepare for global trends
Alexia Haralambous, Senior Principal
RQM+

12:15   LUNCHEON FOR ALL SPEAKERS, SPONSORS AND ATTENDEES

1:15    PANEL DISCUSSION: LAUNCHING A REGULATORY INTELLIGENCE TEAM INTERNALLY 
• Considerations for building a group from scratch
• Practices for growing a successful intelligence network
• Outlining methods for establishing a local market presence
• Progressive tactics for leadership buy-in and team alliance
Charles Jagun, MERZ AESTHETICS
Scott Thiel, HOLOGIC
Shahreen Sharma, BEIGENE USA
Janeen Skutnik-Wilkinson, MODERNA

2:00    COMMUNICATING REGULATORY IMPACT TO YOUR ORGANIZATION: ADVANCED PROCEDURES FOR COMPLIANCE SUCCESS
• Collaboration across departments for regulatory success
• Adopting communication for strategic regulatory planning
• Value of cross-functional teams on regulatory outcomes
• Incorporating intelligence in decision-making processes
• Building partnerships with agencies to better capture data
John W.M. Claud, Counsel
HYMAN, PHELPS & MCNAMARA

2:45   COFFEE AND NETWORKING BREAK

3:15   EVOLUTION OF FDA-REGULATION OF AI-BASED TECHNOLOGY
• Overview of FDA Regulation of Software
• Overview of Artificial Intelligence/Machine Learning (AI/ML)-Enabled Medical Devices and Combination Products
• Predetermined Change Control Plan (PCCP) Guidance and Examples
• Good Machine Learning Practice for Medical Device Development: Guiding Principles
Josh Yao, Director of Regulatory Affairs, Global Regulatory
HOGAN LOVELLS

4:00    PRACTICAL UTILIZATION OF AI AND ML IN THE REGULATORY INTELLIGENCE LANDSCAPE
• Examination of the evaluation of AI tools and systems
• Decoding the impact of AI on budget and resources
• Ways AI can help professionals work proficiently
Aleksandr Merenkov, Associate Director, Global Regulatory Intelligence
GENMAB

5:00   Closing Remarks and End of Day 1

Day Two Agenda
Thursday, February 27

8:00   REGISTRATION AND WELCOME COFFEE

8:20   CHAIRPERSON’S OPENING REMARKS

8:30   FRAGMENTATION TO CONVERGENCE: LEVERAGING REGULATORY FRAMEWORKS & STANDARDS TO DRIVE GLOBAL HARMONIZATION
• Current Challenges in Global Regulations
• Benefits of Harmonization & Convergence
• Opportunities for Harmonization & Convergence
        » AI & Digital Health Regulation
        » E-Labeling and UDI
        » Regulatory Reliance
        » MDSAP and RWE/RWD
Winson Teng, Senior Manager, Global Regulatory Intelligence & Policy
BD

9:15-10:45   SESSION SERIES: IDENTIFYING, LOCATING, AND ANALYZING REGULATORY PRECEDENT

9:15   Part 1 – Utilizing Regulatory Precedence for Decision-Making
• Tools for conducting regulatory precedent research
• The need for an evaluation of regulatory precedents
• The overall benefits of leveraging regulatory precedents
• Processing collected data to establish actionable strategies
Lee O’Brien, ROIVANT
Meenakshi Muthiah, ASTRAZENECA 

10:00   Part 2 – Chemistry, Manufacturing and Controls (CMC) and Regulatory Considerations
• Considerations and anticipated regulatory outcomes
• Understanding the CMC component of regulatory strategy
• Establishing the product development strategy
• Regulatory CMC objectives, hurdles, and risks to success
• Key CMC milestones and decision points
Sree Malepati, Senior Manager, CMC Global Regulatory Affairs
OTSUKA

10:45   COFFEE AND NETWORKING BREAK

11:15   PANEL DISCUSSION: REGULATORY IMPLICATIONS ON FDA’S FINAL LAB DEVELOPED TEST (LDT) RULE: CHANGES, REQUIREMENTS, AND CHALLENGES
• Reviewing regulatory knowledge changes for LDTs
• Assessing the impact and challenges on manufacturers
• Considerations on assay development in clinical studies
• Requirements on inspections, accuracy, and reliability testing
Gail H. Javitt, HYMAN, PHELPS & MCNAMARA
Raya Zerger, BECKMAN COULTER DIAGNOSTICS
Jewell Martin, BIOMARIN PHARMACEUTICAL

12:15   LUNCHEON FOR ALL SPEAKERS, SPONSORS AND ATTENDEES

SESSION SERIES: SOLUTIONS FOR REGULATORY PROFESSIONALS TO ENSURE COMPLIANCE WITH GLOBAL REGULATIONS

1:15  Part 1 – Compliance Management and Reporting Solutions for Ensuring Compliance with Global Regulations
• Methods for seamless compliance management
• Regulatory reporting solutions for data and reports
Carla Amstein, Global Head Regulatory Intelligence
ALCON
Kelli Madden, Senior Regulatory Intelligence Manager
REGASK

2:15  Part 2 – Tools and Approaches for Ensuring Compliance with Global Regulations
• Tools for real-time and shared content for dashboards
• Approaches to optimize resources amid diverse regulations
Anne Madej, Program Director- Regulatory Intelligence
GENENTECH
Kelly Carmona, Senior Director, Head of Regulatory, Product Development Quality Solutions
GENENTECH

3:00   Closing Remarks and End of Day 2