Significant benefits to develop and implement a regulatory plan including detailed strategies have been frequently neglected and/or undervalued. Understanding expectations and evaluating requirements and potential hurdles early in the process can save significant resources (time, energy and money) and beyond.
This seminar is intended to help you develop and implement regulatory guidelines (intelligence-based regulatory plan and strategy) using a CAC-SI method. CAC-SI in this case refers to a Current, Accurate, and Comprehensive regulatory plan and strategy in a Systematic, Integrated Manner.
In this 60-min presentation, the speaker will guide you through the details of the contents for your integration in your regulatory plan and strategy. At the end of the presentation, you should be able to come up with your practical, actionable, and sustainable solutions to your organizations.
- Applicable Laws and Regulations in EU, Canada, and US
- Questions and Issues to Identify and Address
- Interfacing: Roles and Benefits
- Alignments between Functional Departments/Groups
- What Is Critical When Implementing Global Regulatory Intelligence Program
- Mapping Regulatory Requirements and Pathways
- When/How to Prevent Costly Mistakes
- Best Approaches: What to Integrate
- Practical, Actionable, and Strategic Solutions (PASS)
- Speaker’s Experience and Actual Cases
- Regulatory Affairs Departments
- Research and Development Departments
- Quality Departments
- Clinical Affairs Professionals
- Manufacturing Departments
- Engineering Departments
- Operations Departments
- Production Departments
- Marketing Departments
- Senior Management
- Contractors and Subcontractors