TORONTO (PRWEB)
January 24, 2022

As regulatory guidance and expectations for combination drug device products continue to develop, the topic of essential performance requirements (EPR), which is a relatively new term, has been applied to combination drug device products on the market. American. Currently, there are no written guidelines on the subject, however, the FDA is working on a formal guideline to be issued very soon.

Although informal guidelines for RPEs have been shared within the industry, from a regulatory perspective RPEs should be chosen through a risk-based process and documented to show that they are appropriate. for the specific application of the combination product. EPRs should be clinically relevant and relate directly to drug quality and patient safety.

This webinar will educate and provide examples of common EPRs for various types of injectable delivery systems. There will be a discussion of the approach that can be taken to identify risks, characterization and analytical considerations.

Additionally, understanding quality controls to minimize the risks and variability associated with these RPEs is essential to satisfy regulatory agencies and meet patient safety requirements. The approach to these controls will cover supply chain considerations, but will also provide a discussion of how controls relate to established conditions (CE). Established conditions, as defined in ICH Q12, are those elements of the control strategy that are necessary to assure product quality and which, if changed, require regulatory submission after approval.

Join experts from West Pharmaceutical Services, Inc., Fran DeGrazio, Scientific Director; and Jennifer Riter, Senior Director, Business and Technical Operations, for the live webinar on Wednesday, February 16, 2022 at 11:00 a.m. EST (4:00 p.m. GMT/UK) to better understand the overall picture of RPEs from identification, control and life cycle.

For more information or to register for this event, visit Unlocking the mystery of essential performance requirements for combination products.

ABOUT WEST PHARMACEUTICAL SERVICES, INC.

West Pharmaceutical Services, Inc. is a leading provider of innovative, high quality injectable solutions and services. As a trusted partner to established and emerging drug developers, West helps ensure the safe and effective containment and delivery of life-saving, life-enhancing drugs to patients. With nearly 10,000 team members in 50 locations worldwide, West helps customers deliver more than 40 billion components and devices each year. For more information, visit http://www.westpharma.com.

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