News Updates

The DIA Clinical Safety & Pharmacovigilance (CSP) Community aims to help foster best practices, new ideas, and serve as an outlet for meaningful discussions regarding the regulatory environment and processes as they relate to clinical safety and pharmacovigilance (PV) for product development. Our goal is to enhance the general knowledge and understanding, as well as to provide a neutral forum for conversation, growth, and action regarding the practice of monitoring the safety of drugs, biologics, and devices in the interest of public health.

In 2016, the CSP community took a major step forward by appointing two co-chairs to oversee and restructure the mission of the community. Co-Chair Dr. Elizabeth “Beth” Garrard, PharmD, has been a long standing DIA member with more than 20 years of experience and also serves as a key program committee member for DIA’s Annual Meeting and safety/PV-related conferences year-round. Beth looks to serve the community by providing experience and a knowledgeable background to help improve the information being shared amongst the membership. Listen toElizabeth’s 2015 podcast on clinical safety and pharmacovigilance.

I joined DIA in 2015 in order to gain access to a global forum within safety and PV and to maintain my understanding of the current and changing environment of the regulations surrounding this area. I was invited to co-chair the CSP community along with Beth, as we worked to revive the community through member engagement. The resulting outcome has been an increase in involvement, community communication, the development of a new core leadership team, and the generation of a more focused and education driven mission for 2017-2018.

What Have We Accomplished?

Reviving a community takes time, therefore our primary focus this year has been engagement, developing interest, and selecting a core leadership team. Earlier in the year, we surveyed our members to gather key topics of interest to help shape the focus areas for future meetings. In addition to hearing from the co-chairs regularly, we invite guest speakers to participate in our discussions; topics have included Brexit and its impact on PV, and pharmacology and PV implications of biological products. Most recently, we appointed a Core Leadership Team who will aid the Community Chairs in our quest to continue progress. The Core Leadership Team includes Jill Notte (USA) as Communications Coordinator, Cristina Parau (UK) as Education Coordinator, Teiki Iwaoka (Japan) as Member Engagement Coordinator, and Pierre-Yves De Zeeuw (Denmark) as our Program Coordinator. Together, we aim to exceed our accomplishments from 2016 and continue to raise our voices within and outside of DIA!

Who Are Our Community Members?

CSP Community members are professionals and educators, new to the industry as well as tenured, who are involved in all aspects of product safety monitoring. They use our community to evaluate and disseminate important and ever-changing information on the processes, standards, and technologies used to generate and manage safety and PV data. Our members come from a variety of backgrounds within CROs, pharmaceutical and product development companies, as well as from the EMA, FDA, MedDRA, and other regulatory bodies across the globe. Individuals interested in joining should be willing to engage in conversations and community activities in order to help us achieve our goals. We rely on strong motivated professionals from around the world to serve as important resources for new regulations and guidance related to PV and drug safety, and have been excited to see an increase in involvement from several of our members over the last year.

Should I Join? What Can I Expect?

The CSP Community is open to all active DIA members. If you are interested in driving development, engaging in meaningful and constructive conversations, or in advancing your knowledge and skills within our focus area, this community is for you! Those who are interested, willing to participate, and are involved in product safety and pharmacovigilance should consider joining. Join the CSP Community!

In 2017, the CSP community aims to provide more educational topics, opportunities for cross-collaboration with other DIA Communities, and opportunities for the community at large to voice and publish opinions and reviews of the safety and PV environment. Our goal is to meet monthly, for about an hour (along with core team members and co-chairs), to ensure that the communication, content, and developments within the community are maintained according to our mission. Community calls, presentations, and recordings are also available to those who may not be able to attend regularly scheduled calls.

Those of you who are not members, join us! Members, we hope that you will continue to increase your involvement as we work towards our mission of Driving Insights to Action!