Article of the Year

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 per­cent 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 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 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