Webinar Duration: 60 minutes

RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)

SPEAKER: Lauren Neighbours

Today’s biopharmaceutical companies are charged with making the most out of their limited resources (time, money, and personnel) to successfully bring products to market. 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 program can lead to more efficient product development and greatly increase the likelihood of marketing authorization.

This session will discuss key strategies to develop a targeted regulatory strategy for managing an effective product development program. The session will provide tips on team building, creating product development plans, choosing your regulatory pathway, regulatory authority interactions, and partnership strategies, while also including case studies to illustrate how these tips can prevent common pitfalls and lead to success.

Why should you Attend: Are you a small or mid-size biopharmaceutical company competing with big pharma giants to successfully bring products to market? Are you bogged down with the complexities of developing an effective regulatory development strategy in today’s complicated environment? Join this webinar to learn about best practices for preparing and executing a regulatory strategy for the entire product development lifecycle.

Areas Covered in the Session:
– Discuss regulatory planning tools that are useful for building a product development strategy
– Provide stepwise approach to building product development strategy
– Present best practices for preparing for regulatory authority meetings
– List common pitfalls associated with poor product development planning
– Identify ways to apply best practices to future development strategies

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

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. Lauren also has experience coordinating and overseeing the strategy and operations of full-service Phase 1-4 clinical studies spanning many therapeutic areas and product types. Lauren has authored a variety of clinical and regulatory documents, and has contributed as an author to multiple IND/CTA and marketing application dossiers.

Lauren holds a PhD in Microbiology and Immunology and obtained her Regulatory Affairs Certification from the Regulatory Affairs Professional Society. She maintains professional membership with several regulatory and pharmaceutical societies and serves as the Vice President of Programs for the North Carolina Regulatory Affairs Forum.