Life Science Regulatory Intelligence & Strategy Professional Engagement Course
December 11, 2024 | Virtual Event
Examining The Practical Uses Of Tools, Strategies, and AI in Regulatory Intelligence Operations While Strengthening Overall Regulatory Compliance by Aligning Policy Efforts to Impact Upcoming Regulatory Changes
Filsun Moussa
Senior Manager Regulatory Affairs Data & Operations
MEDTRONIC
Lee O’Brien
Senior Director, Regulatory Strategy
ROIVANT
Alex Smith
Director of Regulatory Sciences, Global Regulatory
HOGAN LOVELLS
Jemin Dedania
Director of Regulatory Affairs, Global Regulatory
HOGAN LOVELLS
Charles Jagun
Regulatory Senior Manager
MERZ AESTHETICS
Raya Zerger
Senior Staff, Legislative Initiatives, Regulatory Affairs
BECKMAN COULTER DIAGNOSTICS
9:50 CHAIRPERSON’S OPENING REMARKS
10:00 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
Filsun Moussa, Senior Manager Regulatory Affairs Data & Operations
MEDTRONIC
10:45 REGULATORY FRAMEWORK FOR CYBERSECURITY AND DATA PROTECTION
• Assessing the latest data privacy and cybersecurity changes
• Data breaches and considerations related to data protection
• Coordinated efforts on managing associated risks
• Building a framework to address regulatory obligations
Alex Smith, Director of Regulatory Sciences, Global Regulatory
HOGAN LOVELLS
11:30 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, Regulatory Senior Manager
MERZ AESTHETICS
12:15 LUNCH & NETWORKING BREAK
1:15 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
Raya Zerger, Senior Staff, Legislative Initiatives, Regulatory Affairs
BECKMAN COULTER DIAGNOSTICS
2:00 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
Jemin Dedania, Director of Regulatory Affairs, Global Regulatory
HOGAN LOVELLS
2:45 IDENTIFYING, LOCATING, AND ANALYZING REGULATORY PRECEDENT
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, Senior Director, Regulatory Strategy
ROIVANT
3:30 Closing Remarks and End Course
Previous Attendees Include:
Associate Director, Regulatory Strategy, AGIOS PHARMA
Regulatory Affairs, Specialist, ARTHREX INC
Director, Regulatory Intelligence, ASTRAZENECA
Assoc Dir. Global Regulatory Affairs, BAXTER
Head, Regulatory Intelligence, BAYER
VP Regulatory Strategy, Policy and Intelligence, BD
Sr. Director, Regulatory Intelligence, BEIGENE
Regulatory Manager, COCHLEAR
Lead, Regional Regulatory Affairs, CSL BEHRING GMBH
Associate Director, Regulatory Intelligence, CSL BEHRING
GMBH Global Lead, Regulatory Intelligence, CSL BEHRING
GMBH Sen Director, Head of Reg Policy, EISAI PHARMA
Reg Policy Analyst, GENENTECH
US CMC, Regulatory Policy, GENENTECH
Global Regulatory Policy Intelligence Lead, GENENTECH
Sr. Director, GLAXOSMITHKLINE
Sr. Global RA Compliance Specialist, HOLOGIC
Director, HYMAN, PHELPS & MCNAMARA
Sr. Business Process Architect, INTUITIVE SURGICAL
Associate Director, Global Regulatory Affairs, JANSSEN
Senior Director, Regulatory Affairs, JANSSEN
Director, Regulatory Policy & Intelligence, LEO PHARMA
Head of Regulatory Policy, NEURONA THERAPEUTICS INC
Director, Regulatory Policy, NOVONORDISK
Assoc. Dir. Regulatory Policy and Intelligence, NOVONORDISK
VP, Regulatory Policy & Intelligence, ROCHE DIAGNOSTICS
Director, Regulatory Policy & Intelligence, SHIONOGI INC
Senior Compliance manager, SMITH & NEPHEW
Senior Director, Regulatory Affairs, STERIS CORPORATION
Senior Director, Regulatory Affairs, TELEFLEX MEDICAL
Assoc. Director, Regulatory Legal Group, TEVA PHARMA
….And Many Many More
Who should attend:
Executives from the life science industry that will find this program of greatest application are those involved in leveraging regulatory knowledge to ensure up-to-date compliance and impact product approvals and strategic implementation of policies. With a blend of communication, government policy, technological exchange and employee program engagement, the role of today’s regulatory intelligence executive combines a tremendous number of skills. Recognizing the criticality of regulatory strategic intelligence, the Q1 Life Science Regulatory Intelligence, Strategy & Execution Conference attracts a range of executives with job titles including:
Job titles for this meeting include VPs, Directors, and Managers of:
• Regulatory Intelligence
• Regulatory Strategy
• Regulatory Policy
• Regulatory Affairs
