Month: March 2023

A “WIN” for FDA’s ORA Women Investigators

In Interview with

Andrace De Yampert, MS

This Women’s History Month, we’d like to express our gratitude to those in the clinical research community who dedicate their careers to advancing inclusivity and equality in our field. Whether through small acts of empowerment or sweeping organizational changes, every effort helps pave the way for a brighter future for all.  

In the spirit of empowering women in clinical research, this post will introduce you to the Women’s Investigator Network (WIN) and the women behind it. This distinctive program at the Food & Drug Administration (FDA) Office of Regulatory Affairs (ORA) supports women serving as ORA investigators by providing opportunities for professional development, leadership training, and personal empowerment. With more than 300 members and growing, WIN is a shining example of how organizations can foster a culture of inclusivity and diversity within the clinical research community. 

In honor of WIN’s second anniversary, we caught up with Andrace De Yampert, FDA ORA Office of Bioresearch Monitoring Operations (OBIMO) Program Expert and WIN Vice Chair, to learn more about her, the network, and its impact on women investigators at the FDA.  

Continue reading A “WIN” for FDA’s ORA Women Investigators →

10 Reasons to Attend the 16th Annual Device Research & Regulatory Conference

Angie Rock

MBA, CCRP

Kathi Durdon

MA, CCRP

Early in her medical device research career, Kathi Durdon, MA, CCRP, discovered a gaping hole in the professional conference offerings: most were geared toward pharmaceuticals, not devices – so she created one.

“My initial incentive for starting an annual device conference was because I needed help. I wanted to connect with subject matter experts, get new updates, and share resources. I knew it would be helpful for others, too,” said Kathi. As a member-driven organization, SOCRA enthusiastically supported Kathi’s vision, and the Annual Device Research & Regulatory Conference was born.

“Thanks to SOCRA’s support, I could create a different kind of conference – one where attendees would come every year to discuss and learn about an evolving array of topics. I also wanted a full complement of speakers who are experts in different areas – not just one or two areas,” Kathi recalled.

With Kathi at the helm, the first Device Research & Regulatory Conference was held in 2007, and sixteen years later, it’s still the medical device research “go to” conference. The conference started as a two-day program and then the faculty added a half-day Device Basics workshop thanks to past co-chair, Donna Headlee, RN, BSN, CCRP, who developed and still presents at the program today.

As we gear up for the 16th year, the Device Research & Regulatory Conference is still going strong. And as Kathi prepares to turn over the reins to Angie Rock, MBA, CCRP in 2024, the two gathered to commemorate Kathi’s tenure, to discuss the importance of the program, and to discuss future plans for the conference.

“This conference is Kathi’s brainchild. I’m honored to be a part of this phenomenal program – it is the premier conference for medical device professionals and one of the first that is entirely clinically oriented,” said Angie.

In this post, we’ll outline Kathi and Angie’s top ten reasons to attend this annual conference and why it’s important for device newbies and experts alike.

Continue reading 10 Reasons to Attend the 16th Annual Device Research & Regulatory Conference →