Unlocking the Mystery of Essential Performance Requirements for Combination Products, Upcoming Webinar Hosted by Xtalks

TORONTO, Jan. 24, 2022 /PRNewswire-PRWeb/ -- As the regulatory guidance and expectations around drug device combination products continues to develop, the topic of Essential Performance Requirements (EPRs), which is a relatively new term, has been applied to drug device combination products in the US market. Currently there is no written guidance on the subject, however, the FDA is working on a formal guidance which is to be released sometime soon.

Although informal guidance for EPRs have been shared within industry, from a regulatory perspective, the EPRs should be chosen based on a risk-based process and documented to show they are appropriate for the specific combination product application. EPRs are to have clinical relevance 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 on the approach that can be taken in identifying risks, characterization and analytical considerations.

In addition, the understanding of quality controls to minimize risks and variability associated with these EPRs is critical to satisfy regulatory agencies and meet patient safety requirements. The approach to these controls will cover considerations in the supply chain, but also provide a discussion of the tie of controls to Established Conditions (EC). Established Conditions, as defined in ICH Q12, are the elements of the control strategy that are necessary to assure product quality and, that if changed, require a post-approval regulatory submission.

Join experts from West Pharmaceutical Services, Inc., Fran DeGrazio, Chief Scientific Officer; and Jennifer Riter, Senior Director, Business and Technical Operations, for the live webinar on Wednesday, February 16, 2022 at 11am EST (4pm GMT/UK) to gain an understanding of the total picture of EPRs from identification, control and lifecycle.

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, effective containment and delivery of life-saving and life-enhancing medicines for patients. With almost 10,000 team members across 50 sites worldwide, West helps support our customers by delivering over 40 billion components and devices each year. For more information, visit http://www.westpharma.com.

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Media Contact

Ayesha Rashid, Xtalks, +1 (416) 977-6555 x 272, [email protected]

SOURCE Xtalks