Preconference Workshop
Applied
.png "Joao Duarte, MSc, MPharm photo")
Joao Duarte, MSc, MPharm
Associate Director, Regulatory Intelligence
Alexion Pharmaceuticals
Kirsten Messmer, PhD, RAC
Principal Regulatory Affairs Specialist
PPD
Linda Bowen, MS, RAC, FRAPS
Head of Regulatory Policy and Intelligence
Seattle Genetics, Inc.
Janet Vessotskie, PhD MPH
Sr. Dir., Global Regulatory Intelligence & Policy
This masterclass lays the foundation for skills crucial for developing robust regulatory intelligence that adds value to the research and development program at every level. This highly interactive class will provide an overview of the fundamentals of global regulatory intelligence including what it is ,explore value building applications during the drug development process and beyond. Regulatory intelligence aids strategy development, provides solutions to overcoming roadblocks, helps filling knowledge gaps, spots trends and provides potential competitive advantages amongst other objectives to add value to a product, program and/or company. During the workshop, discussions, hands-on exercises and polls will provide opportunities to learn and apply effective methods for collection, monitoring, impact assessment and communication of regulatory intelligence within the team, the management chain, the company and outside stakeholders. Effective regulatory intelligence communication also becomes imperative to positively shape the regulatory environment. During the workshop, participants will apply learned skills and techniques in case studies to develop global regulatory strategies, precedents, competitive analysis and communication in biopharmaceutical drug development.