Product Registration: Writing a Better Dossier; Tracking Process and Outcomes
Sponsored by: AMPLEXOR Life Sciences
- Product Registration
- Medical Devices
Date: 30 April
Time: 3PM London/10AM New York
Ministries of Health across the world continue to request that Life Sciences organizations improve the quality of their applications. We've heard their plea for decades. Similarly, management demands better registration metrics. Regulatory Affairs has a role as a strategic partner for both.
This presentation offers methods for improving the quality of the application thereby leading to reduced approval times, and recommendations for tracking and measuring the registration process from request through approval: you'll be able to effectively respond to the regulatory and measurement questions that are foundational across all companies: pharma, biotech and medical devices alike.
Connie Dominguez, RAC,
Founder and Owner, Regulatory Language Matters
Connie McDuffee Dominguez, RAC has registered products as diverse as antibiotics, hip and knee implants, OTC products, nutritional formulas and supplements, and biopsy devices around the world during her career in Global Regulatory Affairs. Her abiding passion has been to reduce regulatory approval time to speed product to the patient.
Connie has accomplished that using methods that span functions and geographies of the organization. She has lived and worked across the U.S. and in Chile and is fluent in English and Spanish. Connie currently lives in Phoenix, Arizona, U.S.A. where she is the founder and owner of Regulatory Language Matters, LLC.
Key Learning Objectives
- How to improve the quality of the application and approvals process?
- Prescribe recommendations for tracking and measuring the registration process
- Product Life Cycle Planning
- Notified Body Selection
- Regulatory Document Writing
- Device Registration
- Clinical Evaluation
- Post Market Surveillance
- Research & Development
- Regulatory Affairs
- Clinical Affairs
- Product Development