Developing and Managing Regulatory Intelligence (2-Day Virtual Event)

When:  Dec 18, 2019 from 12:00 to 15:00 (ET)

Regulatory Intelligence (RI) is invaluable. As regulatory professionals, we must develop new skillsets to fully realize the importance and value of RI.

In Regulatory, we are often presented with questions that need to be researched and answered. Some questions are urgent, such as when a new guidance is issued that appears to counter previous policies or practices. Others may need to be reassessed multiple times throughout product development to avoid unpleasant, late-stage surprises. Regulatory intelligence is essential in answering these questions.

The types of regulatory intelligence we use varies as widely as the products we work with.  Government transparency initiatives continue to offer an increasing amount of regulatory data and information, which serves as the basis for insights that were not available just a few years ago. This virtual event is designed to provide an overview of the types and uses of RI, as well as practical strategies for effectively locating, using, communicating with and managing RI.

Learning Objectives:

Identify the types of RI that will be useful in your company

Utilize effective ways to manage your RI

Find the necessary information used for RI

Topics Covered:

Skills needed to capture and use RI

Communicating RI with colleagues

Best practices for organization of your RI

Examples of the benefits and consequences of using RI

Where to find the data and information you need

Key performance indicator reporting, including CBER, CDER CDRH

Who Should Attend?

Regulatory professionals involved with product or drug submissions and approvals.

Regulatory professionals involved in creating regulatory strategy for submissions.

Quality professionals responsible for ensuring quality systems are in alignment with regulatory affairs.

Regulatory affairs consultants

Presenters:

Melissa Walker, RAC, founder, president and CTO, Graematter, Inc.

Al Edwards, PharmD, founder, eSubmissions University

Donna Haire, founder and CEO, The Eriah Group, LLC

Alison Sathe, founder, Regulatory Mark


Additional Presenters TBA


**Draft Agenda is Coming Soon**

Webcast registration includes access to handouts, presentation slides and the on-demand recording for one year.