Overview:
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
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
Speakers
Lauren Neighbours,
Who Should Attend
- 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
