Regulatory Open Forum

Hi RegEx Members,

In case you missed it, the 1st Quarter Regulatory Focus Article Series of 2020, The Strategic Role of the Regulatory Professional is here. In this RF series, you will find a find a collection of insightful articles covering the expanding strategic role of regulatory professionals and the vital role regulatory plays within organizations and throughout the product lifecycle. It is a pleasure to bring together some of the top regulatory influencers from around the world--all with diverse experiences--to offer their perspectives on how the shifting landscape and evolving regulatory approaches are impacting the regulatory profession today.

Individual articles examine:

• The Changing Role of the Regulatory Professional
• How the Role of Regulatory Operations Professionals Will Evolve in the new Decade
• Why Understanding Regulatory Affairs is Important to Key Company Decision Makers
• Writing Informed Consent Documents: A Balancing Act
• Regulatory Affairs Consultants: Who needs them and why?
• Consultants: How to Hire and Engage for Success
• Assessing Risk and Strategic Business Decision-Making Without Consistent FDA Enforcement
• Transitioning Between Medical Writing and Regulatory Affairs in a Contract Research Organization
• Professional Development: Benefits of Obtaining Professional Qualifications
• Regulatory Leadership for a Culture of Quality
• Critical Thinking and Leadership Skills for Regulatory Professionals

Download the latest RF Article Series HERE.

Mark your Calendars: To support the launch of the Article Series, we will be hosting an "Ask Me Anything" session on Wednesday, 8 April, from 1:30-2:30 PM EST right here on RegEx. This session will be made up of regulatory experts, who will be discussing the article series and available to answer your questions in real time.

I look forward to hearing your thoughts on this article series.

Best wishes,

Gloria