FDA | Biologics Effectiveness and Safety (BEST)


CBER BEST Initiative Seminar Series – Understanding Informed Presence in Electronic Health Records Data

The CBER BEST Initiative Seminar Series will have Dr. Ben Goldstein, PhD, MD on May 5, 2021, 11:00-12:00 PM, EDT. He will be presenting on informed presence in electronic health records data. For more information about our presenter and his presentation, see our flyer. Anyone can register and join for free.

CBER BEST Initiative Seminar Series – “Vaccine Safety Surveillance Systems for Routine and Pandemic Immunization Programs”

The CBER BEST Initiative Seminar Series is designed to share and discuss recent research of relevance to ongoing and future surveillance activities of CBER regulated products, namely biologics. The series focuses on safety and effectiveness of biologics including vaccines, blood components, blood-derived products, tissues and advanced therapies. The seminars will provide information on characteristics of biologics, required infrastructure, study designs, and analytic methods utilized for pharmacovigilance and pharmacoepidemiologic studies of biologics. On Wednesday, March 24, 2021, Dr. Dan Salmon presented on “Vaccine Safety Surveillance Systems for Routine and Pandemic Immunization Programs.”

Seminar Recording: https://vimeo.com/528468920/0527eab12a

Disclaimer: This presentation reflects the views of the author and should not be construed to represent FDA’s views or policies.

AMIA Annual Virtual Symposium 2020

On Tuesday, November 17, 2020 from 2:00-3:30 pm ET, the BEST Initiative panel is discussing The Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) Biologics Effectiveness and Safety (BEST) Initiative: How Informatics Can Assist the Secondary Use of Electronic Health Records to Inform Regulatory Decisions. The panel presents an overview of the BEST Initiative and informatics considerations for the secondary use of EHRs. Using case studies in biologics, the panel will discuss ascertainment of exposures and outcomes in EHRs, development of semi-automated tools for EHR-based chart review and adverse event reporting, and interoperability and portability of computable phenotypes across EHRs. This interactive session will engage participants to understand the goals and challenges of biologics surveillance using EHRs. For more information and registration, please see AMIA Annual Virtual Symposium 2020 (November 14-18, 2020).

2020 OHDSI Symposium

Registration is now open for the 2020 OHDSI Symposium, which will be held virtually October 18-21, 2020. The 6th Annual OHDSI Symposium will feature everything that makes the event an annual highlight for so many community members, including plenary sessions, tutorials and the Collaborator Showcase, as well as a two-day study-a-thon, to bring its global community together to collaboratively generate real-world evidence on an important healthcare issue. This year there will be no fees to attend any of our four-day, virtual events.

Twelfth Annual Sentinel Initiative Public Workshop

The Twelfth Annual FDA Sentinel Initiative Public Workshop is scheduled for Wednesday, October 14, 2020 from 1-4 PM EST. The online workshop provides an opportunity to discuss recent achievements and engage with the broader community of patients, consumers, and scientific stakeholders. For more information and registration, please see 12th Annual Sentinel Initiative Public Workshop webpage

International Society for Pharmacoepidemiology: ICPE All Access (September 2020)

Access an on-demand oral presentation by Dr. Keran Moll (IBM Watson Health) on Validating Claims-based Algorithms Identifying Pregnancy Outcomes at the International Society for Pharmacoepidemiology, ICPE All Access, September 2020