LIVE | 08:00 AM PST | 11:00 AM EST | Duration: 60 Minutes.
Dates to Choose from:
Tuesday, January 29, 2013
Monday, February 25, 2013
Tuesday, March 05, 2013
Friday, April 26, 2013
Friday, June 21, 2013
Friday, September 27, 2013
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About the Seminar
Benefits to develop and implement a regulatory plan including detailed strategies under the said plan 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 webinar 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 Concise, Accurate, and Comprehensive regulatory plan and strategy in a Systematic, Integrative Manner.
In this 60-min presentation, Regulatory Doctor will guide you through the details of the Contents for your integration in your regulatory plan and strategy. He will also share his practical, actionable, and sustainable solutions to your organizations.
About the Areas to Be Discussed
- Applicable Laws, Regulations, Guidance, Rules, and Standards in EU, Canada, and US
- Regulatory Intelligence for Drugs, Biologics, Biosimilars, and Medical Devices including In Vitro Diagnostic Medical Devices (IVDs)
- R&D, Patent and Applicable Regulatory Pathways
- Questions and Issues to Identify and Address
- Totality and Flexible Approaches
- Interfacing: Roles and Benefits
- Reimbursement Issues: What, When, Why, and How
- Intellectual Property (IP) Issues
- Alignment between Regulatory Plan/Strategy, Reimbursement, and IP
- Detailed Contents
- Practical, Actionable, and Sustainable Solutions (PASS)
- Speaker’s Experience and Actual Cases
- Providing Accurate and Precise Direction and Guidance!
About the Intended Attendee(s)
- Regulatory Affairs
- Research and Development (Engineers and Scientists); Product Development (Engineers and Scientists)
- Clinical Affairs
- Senior Management
- Contractors and subcontractors
- Anyone interested in the topic
To register, click here.