In this 505(b)(2) related webinar, know the complete details, key strategies, regulatory considerations, and marketing strategies for developing 505(b)(2) products.
Areas Covered in the Seminar:
- The 505(B)(2) regulation and guidance from the FDA.
- Strategic considerations before embarking on a 505(b)(2) development project.
- Intellectual property issues with such products.
- Key development steps for such products.
- FDA's review process and ongoing consultation.
- Challenges to developing 505(b)(2) product and possible solutions.
- Examples of successful strategies for developing such products.
- Searching for a 505(b)(2) project, future trends.
- 505(b)(2) and biosimilars.
Who Will Benefit:
This webinar will provide valuable assistance to all personnel in:
- Regulatory affairs professionals
- Senior management executives (CEO, COO, CFO, etc)
- Drug discovery and development professionals (R&D and CMC)
- Intellectual property experts
- Project Managers and Clinical trial specialists
- Regulatory Compliance Associates and Managers
- People investing in FDA-regulated product development projects
Note: ComplianceOnline provides 20% Discount on any Second purchase of Webinar