Component Type: Tutorial
CE: ACPE 2.75 Knowledge UAN: 0286-0000-21-510-L04-P; CME 2.75; IACET 2.75; RN 2.75
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Data from randomized controlled clinical trials (RCTs) have traditionally played a primary role in regulatory decision making. However, the increasing cost of clinical development coupled with challenges in studying hard to reach populations, rare diseases, and rare endpoints (such as for safety outcomes), along with a general lack of understanding as to how medical products are used in practice, has motivated regulators and pharmaceutical industry sponsors to explore the utility of other sources of data. The 21st Century Cures Act passed by the US Congress in 2016 empowers the US Food and Drug Administration to accelerate the approval process by allowing data from real-world data (RWD) sources to support new indications for approved drugs, or to support or satisfy post-approval requirements.There is a growing demand for fast, timely, and relevant public health data on patient safety. This has resulted in increased expectations for well-designed, well-executed, and well-reported observational studies. In addition, there is a rise in the demand for using RCTs to understand treatment effects in a more real-world setting. To face these challenges and potential opportunities, the ICH and various regulatory authorities are developing guidance to incorporate data from RCTs and RWD to enable relevant decision making. These ideas are reflected in the recent updates of ICH E2C for periodic benefit-risk evaluation report, the E6/E8 renovation paper, the ICH E9 R1 estimand discussion, as well as the recent FDA framework on the use of real-world evidence (2018).
Throughout the course, we cover lessons learned over the last decade of REMS implementation, and how implementation approaches continue to evolve to support safe use and product access, while reducing overall burden of REMS on the healthcare landscape. Using examples from approved REMS programs, we explore how key concepts are applied in the real world. By the end of this course, participants have an expanded understanding of REMS and the knowledge necessary to be involved in development, approval, implementation, and/or administration of a REMS program.
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DIA 2021 Who should attend? This short course is designed for: Professionals who may become involved in the development, implementation, or administration of a REMS program, which includes biopharmaceutical companies, vendors serving the biopharmaceutical industry, and those who regulate the biopharmaceutical industry. It’s also intended for those who wish to expand their overall knowledge of the drug safety landscape of which REMS is a notable component.
Learning Objectives Describe business and regulatory challenges unique to products with an associated REMS; Summarize how REMS programs are initiated, developed, approved, launched, and operated; Discuss the differences and similarities between new product and generic product REMS programs.
