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Session 8, Track A: Devise Effective Regulatory Strategy: Using the Lens of Regulatory Intelligence
Session Chair(s)
Louise Blythe, MSc
Head, Regulatory Affairs
Bayer Inc. Canada, Canada
Melanie Cote, MS
Senior Manager, Global Regulatory Affairs
Otsuka Pharmaceutical Development & Commercialization Inc., Canada
Join us for a professional development session that explores how to leverage Regulatory Intelligence to drive regulatory strategy and improve submission outcomes. Presenters will share insights on various approaches to manage regulatory intelligence (e.g., health authority advice/feedback, regulatory precedents), the significance of post-approval insights, and techniques that translate intelligence into actionable strategies aligning with Health Authorities evolving frameworks, including Health Canada. Attendees will enhance their skills in navigating the evolving regulatory environment, ultimately improving their professional expertise and impact.
- Regulatory Intelligence to Drive Regulatory Strategy
Meena Muthiah, Astrazeneca - The Submission Isn't Over: Strategically Leveraging Post-Agency Feedback to Future-Proof Submissions
Anaya Rehman, Certara - Building Regulatory Strategies Using Regulatory Intelligence in Canada’s Evolving Healthcare Environment
Pooja Sharma, Allucent Inc.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Gain a comprehensive understanding of how regulatory intelligence can enhance decision-making and shape regulatory strategies
- Acquire various approaches and practical techniques for constructing robust frameworks that translate regulatory intelligence into actionable strategies
- Improve their ability to navigate the dynamic regulatory environment and enhance their professional impact
Speaker(s)
Regulatory Intelligence to Drive Regulatory Strategy
Meena N. Muthiah, MPH, MS, RAC
Astrazeneca, United States
Director, Regulatory Intelligence & Policy
The Submission Isn't Over: Strategically Leveraging Post-Agency Feedback to Future-Proof Submissions
Anaya Rehman, MD, MS
Certara, Canada
Senior Transparency Specialist
Building Regulatory Strategies Using Regulatory Intelligence in Canada’s Evolving Healthcare Environment
Pooja Sharma, MPharm
Allucent Inc., Canada
Regulatory Affairs, Senior Scientist
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