US Regulatory Submissions and Publishing 101: Keys to Success

Overview:

Effective regulatory strategy, like product design, requires "quality-by-design" approach and planning throughout the product development lifecycle. For pharmaceutical, device, and biotechnology companies, understanding how to effectively design and manage a regulatory submission can lead to a more efficient application development process and greatly increase the likelihood of marketing authorization.

This session will discuss proven strategies for managing an effective regulatory submission program. The session will provide tips on planning your regulatory submission, regulatory authority interactions, and provide a stepwise approach to regulatory submission development and publishing. We will also present relevant case studies to illustrate how these tips can prevent common pitfalls and lead to a better outcome for your submissions.

Why should you Attend: Are you bogged down with the complexities of developing an effective regulatory application submission strategy in today's complicated regulatory environment?

Are you a small or mid-size biopharmaceutical company looking for more efficient ways to successfully bring products to market?

Are you a regulatory writer looking for new or innovative ways to develop high-quality, eCTD-compliant documents for regulatory submissions?

Join this webinar to learn about best practices for preparing and executing regulatory submissions for product development programs. We will discuss a proven, stepwise approach to successfully preparing your regulatory strategy, effectively interacting with regulatory agencies, and developing high-quality US regulatory submissions.

Areas Covered in the Session:

• Provide an overview of US regulatory submissions, focusing on INDs, NDAs, and BLAs for drugs and biologics
• Discuss regulatory planning tools that are useful for building a product development strategy
• Provide stepwise approach to developing regulatory submissions
• Present best practices for preparing for regulatory authority meetings
• Review publishing process for electronic submissions to FDA
• List common pitfalls associated with poor submission planning
• Identify ways to apply best practices to future regulatory submissions

Who Will Benefit:

• VP, Regulatory Affairs
• VP, Clinical Development
• Director, Regulatory Affairs
• Director, Quality Assurance
• Manager, Regulatory Affairs
• Project Manager
• Project Director
• Manager, Clinical Operations
• VP, Research and Development
• VP, Clinical Operations
• Independent Regulatory Consultant
• Regulatory Writer
• Regulatory Affairs Specialist

Speaker Profile
Lauren Neighbours is the Head of Regulatory Affairs, North America at PSI where she leads regulatory strategy for PSI in the US and Canada. Lauren has over 10 years of scientific research experience within industry, government, and academic settings. She has led multidisciplinary product development programs from the pre-IND stage through marketing, partnering with early-, mid-, and late-stage companies to develop and refine strategic development plans, design and execute clinical studies, lead regulatory submissions, and provide support for regulatory authority meetings and other consulting needs.