Challenges with Planning and Generation of Development Safety Update Reports (DSURs) and How to Overcome Them

The Development Safety Update Report (DSUR) is an aggregate safety report covering drugs, biologics, vaccines or combo products, whose format is harmonized by ICH E2F guideline The DSUR is accepted in most countries worldwide. It replaces the EU Annual Safety Report and the IND Annual Report. These former reports were not as complex as the DSUR. Because of that complexity an intensive training of staff responsible for generation of DSURs is highly recommended. In the training special attention is to be paid to the definition of the Development International Birthdate (DIBD) and the reporting period, the programming of line listings and summary tabulations, correct categorization of ongoing and completed clinical trials as well as on risk analysis and risk-benefit considerations.

In this webinar attendees will learn about the importance of early and careful planning of all activities related to the generation and submission of DSURs, which includes resource planning. The DSUR contains some unblinded data, which is an additional challenge for smaller companies as personnel involved in the conduct of ongoing studies may not be involved in the DSUR preparation or review. Finally the speaker will share guidance for the review of the draft report ensuring that the final DSUR not only meets regulatory requirements, but is also a useful tool to understand the benefit-risk profile of your compound and a valuable data source for its further development.

Speaker

Sabine Richter, PhD, M.Sc, Vice President Safety and Risk Management, PRA

Dr. Richter has over 25 years of research experience in the Pharmaceutical and CRO industries, as well as in academia. As the Vice President she is responsible for all aspects of PRA’s Safety and Risk Management services. To ensure consistent high performance and regulatory compliance, Dr. Richter developed robust contract language and quality control measures. In the past years, she focussed on the training and implementation of the new EU PV legislation within PRA.

In her career, Dr. Richter held various positions in Project Management, Clinical Operations, Quality Management and Strategic Proposals and Contracts. She managed numerous clinical phase II/III international projects in multiple therapeutic areas, such as infectious disease and vaccination, oncology, CNS, cardiovascular, and diabetes. Joining PRA’s Drug Safety team in 2004, she assumed responsibility for a large, long-term safety program for a new oncology product that was conducted in over 50 countries and five continents. As a member of Executive and Operational Oversight Committees, Dr. Richter provides leadership to project teams, supports the development of client relationships, and the improvement of operational excellence.

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