How will the now-in-effect EU Medical Device Regulation (EU MDR) affect combination products, particularly drug-device combination products? What is the latest regulatory thinking on smart combination products? And what are some of the recent FDA guidances related to combination products?

For insights into these questions, check out the latest Redica Systems report, “An In-Depth Look at Combination Product Regulations.” This report features two articles by Redica Systems Senior GMP Quality Expert Jerry Chapman, a Q&A interview with Redica Systems GMP Medical Device Expert Mark Agostino, and a summary of a webinar that covered recent regulatory and business developments affecting smart combination products.

Click here to access this FREE report.

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What You Will Learn

  • The impact of the EU MDR on combination products
  • How FDA is looking at regulating smart combination products
  • FDA guidances and other documents released on 2020

About the Experts

Jerry Chapman

Jerry Chapman is a Senior GMP Quality Expert at Redica Systems. He brings 40 years’ experience in the pharma industry, including 31 years at Eli Lilly in technical and
leadership positions in research and product development, manufacturing, plant quality, site quality, corporate quality, and quality systems.

Mark Agostino

Mark Agostino is a GMP Medical Device Expert at Redica Systems. His areas of expertise include quality assurance and regulatory affairs for medical device and
combination products. He is also Managing Director of QARA Biomed.

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