Pharmaceutical Engineering® magazine is proud to announce the 2021 Roger F. Sherwood Article of the Year is "Medical Device UDI Components Management in the European Union" (July-August 2021) by Laurence Azoulay, Marie Coulon, PharmD, Christophe Devins, Bernard Durand, Etienne Granier, Amel Guerrida-Marchand, Ye-Lynne Lee, Valérie Marchand, Patrick Mazaud, Brigitte Naftalin, Michel Raschas, and Nadim Wardé.
NORTH BETHESDA, Md., Oct. 19, 2022 /PRNewswire-PRWeb/ -- Pharmaceutical Engineering® magazine is proud to announce the 2021 Roger F. Sherwood Article of the Year is "Medical Device UDI Components Management in the European Union" (July-August 2021) by Laurence Azoulay, Marie Coulon, PharmD, Christophe Devins, Bernard Durand, Etienne Granier, Amel Guerrida-Marchand, Ye-Lynne Lee, Valérie Marchand, Patrick Mazaud, Brigitte Naftalin, Michel Raschas, and Nadim Wardé.
The article focuses on the unique device identification (UDI) portion of the European Union's (EU) Medical Device Regulation (MDR 2017/745) and the In Vitro Diagnostic Medical Device Regulation (IVDR 2017/746), which are binding on all EU member states. The general application dates of the two regulations were 26 May 2021 for medical devices and 26 May 2022 for in vitro diagnostic medical devices; however, different timelines apply for certain specific provisions.
"The article contributes a lot to clarify the complexity of medical devices in combination products use," said Ferdinando Aspesi, Senior Partner, Bridge Associates International, and Chair of the Pharmaceutical Engineering Committee (PEC). "It is known that 80% of new pharmaceutical products under development are combination products, where the medical device is the tool to deliver the active pharmaceutical molecule to the patient. Clearly knowing the requirements of the European Union with its 500 million-plus people is critical for the success and timely availability of new products to patients." Aspesi added that the article will help many readers involved in developing such products and treatments.
About the Award
ISPE's Roger F. Sherwood Article of the Year award was established in 1993 to increase article submissions and improve the quality of those received. In the early years, judges rated each issue's technical articles against a set of six criteria, then selected an annual winner.
Almost three decades later, while recognizing the merit of the original intent, the award has been refreshed to showcase the best content in Pharmaceutical Engineering, increase industry recognition, highlight ISPE's reputation as a global knowledge leader, and bolster magazine content quality.
Although various judges have assessed articles over the years, one constant remains: recognition of quality and excellence in the content through identifying finalists and a single winning article for each publication year.
2021 Judging
A subcommittee of the PEC served as judges for the 2021 award competition, reviewing 35 articles and providing assessments on the following criteria: usefulness to ISPE readers; how the articles improve the knowledge of key topics; and clarity/ease of reading.
The PEC subcommittee was headed by Michelle Gonzalez. Thank you to Michelle and the PEC subcommittee for their work on the 2021 competition.
2021 Award Finalists
- Winner: "Medical Device UDI Components Management in the European Union" (July-August 2021), by Laurence Azoulay, Marie Coulon, Christophe Devins, Bernard Durand, Etienne Granier, Amel Guerrida Marchand, Ye-Lynne Lee, Valerie Marchand, Patrick Mazaud, Brigitte Naftalin, Michel Raschas, and Nadim Wardé
- "ICH Quality Guidelines: Present Initiatives and ISPE Involvement" (September-October 2021), by Nina S. Cauchon, Christine M. V. Moore, and Christopher J. Potter
- "Cloud Computing Implications for Manufacturing Execution Systems" (May-June 2021), by Paul J. Irving, Gregory M. Ruklic, and Jonathan Hurle
- "Model-Informed Drug Development Addresses COVID-19 Challenges" (January-February 2021), by Patrick Smith and Karen Rowland-Yeo
- "Material Properties Databases to Advance Pharmaceutical Processing" (March-April 2021), by Jamie Clayton
- "A Beginner's Guide to IT System Inspection Readiness" (May-June 2021), by Anders Vidstrup
About ISPE
The International Society for Pharmaceutical Engineering (ISPE) is the world's largest nonprofit association serving its members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical lifecycle. The 20,000+ members of ISPE provide solutions to complex pharmaceutical industry challenges through innovation, member and workforce development, technical, regulatory and compliance collaborations in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters and training center in North Bethesda, Maryland, USA, and its operations center in Tampa, Florida, USA. Visit ISPE.org for more information.
Media Contact
Kristin LeMunyon, ISPE, 1-813-960-2105, [email protected]
SOURCE ISPE
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