New biopharma and medical device regulations

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The past decade has seen an unprecedented level of regulatory change in Europe’s biopharmaceutical and medical device industry. These changes have demanded action from industry and regulators, in addition to coordination with a range of stakeholders.

Achieving and maintaining compliance is critical, as this will directly impact whether a product can remain on the market. However, moving to new regulatory standards is not without risk; remediation costs are high and may not have a positive return on investment. Consequently, organizations will have to make key strategic decisions on their portfolio, execution approach and market presence.

In this article, we highlight some notable regulatory initiatives that will impact industry over the coming years. We explore why these are being rolled out, what the impact on industry will be, where the potential challenges are and how value can be realized from these efforts.

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The article was written by:

Michelle Cuddigan
Executive Director, Europe, Middle East, India and Africa (EMEIA) Advisory Centre, Life Sciences, Ernst & Young Ireland
Dr Shanaka Thilak
Senior Manager, EMEIA Advisory Centre, Life Sciences, Ernst & Young LLP

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