Content Matters: Product Registration: Writing a Better Dossier; Tracking Process and Outcomes

30 April 2018

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.

Amplexor's guest presenter, Connie Dominguez, founder and owner of Regulatory Language Matters offers methods for:

  • Improving the quality of applications that can lead to reduced approval times
  • Tracking and measuring the registration process from request through approval
  • Effectively responding to regulatory and measurement questions that are foundational across all companies: pharma, biotech and medical devices alike.

Key Learning Objectives

  • How to improve the quality of the application and approvals process
  • Prescribe recommendations for tracking and measuring the registration process

Connie Dominguez, RAC
Founder and Owner, Regulatory Language Matters

Currently Founder and Owner of Connie McDuffee Dominguez, RAC, has more than 35 years’ experience in Global Regulatory Affairs leadership positions – registering products in pharmaceuticals, nutritionals, medical devices, and OTC products

Her abiding passion has been to reduce regulatory approval time and product speed-to-market for patients. She has accomplished this using methods that span functions and geographies of specific organizations. Connie has lived and worked across the U.S. and in Chile and is fluent in English and Spanish.