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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 United States market. Combination products bring together CDER, CBER and CDRH during the review process of the application the aspect of EPRs has now become an expectation for Combination Products. 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 risked 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 & 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. Q12 is entitled: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.
Understanding the total picture of EPRs from identification, control and lifecycle is critical and will be presented.
Chief Scientific Officer
Senior Director, Business and Technical Operations, Services and Solutions