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As part of the annual West without Borders fundraising campaign, West’s Puerto Rico employees chose to support Centro Margarita, Inc., a 33-year-old center that specializes in rehabilitating children with special needs and/or developmental disabilities.
Employees raised more than $6,300 through of a variety of acitivities, including a bake sale, raffle and picnic. The group also gathered items for the children and the center, including educational toys, groceries and cleaning items.
Centro Margarita was created to provide treatment opportunities for children with severe disabilities from families of limited economic resources. The center incorporates the families into the children’s treatment and provides orientation, education and training to assist in the rehabilitation efforts and education of the children.
West without Borders is not affiliated with Doctors Without Borders®, which is a registered service mark of Bureau International de Médecins Sans Frontières.
Have you successfully developed a drug product in a prefilled syringe and are now wondering how to get it on the European market?<br />According to the European Union Regulation (EU) 2017/745 (MDR) Article 1(9), a prefilled syringe (PFS) is identified as “a single integral product which is intended exclusively for use in the given combination, and which is not reusable, that single integral product shall be governed by Directive 2001/83/EC or Regulation (EC) No 726/2004, as applicable” (1). According to 2017/745 Article 1(9), you must prove that the device part of your combination product complies with the appropriate General Safety and Performance Requirements (GSPRs) laid out in Annex I of MDR. As you can no longer do a self-assessment, you will need to reach out to one of the currently designated 43 Notified Bodies in Europe (2) to do the conformity assessment for you. The results of the assessment are then captured in the Notified Body Opinion (NBOp) which you are required to include in the submission file to EMA or your national competent authority.
I am the Production Manager at our Waterford manufacturing site in Ireland. I have worked at West since 2018 and was the Area Manager for Waterford’s Finishing Department until I was promoted in November 2022.
Members of the West Pharmaceutical Services, Inc. (West) Marketing Unit had the pleasure of attending the recent FDA Public Meeting on Tuesday, May 21, 2019 regarding 503B Compounding Pharmacies and the cGMP draft guidance, as well as office stock issues which had generated many comments.
<span style="color: #333333;">Today, we are more connected than ever before. We rely on the Internet to stay informed and to perform our day-to-day jobs. It’s hard to imagine our lives without the Internet; yet for all of its advantages, increased connectivity brings increased risks for cybercrime. Recognizing the importance of cyber security, President Obama designated October as National Cyber Security Awareness Month (NCSAM), as has the European Network and Information Security Agency (ENISA). At West, we are committed to ensuring the ongoing success of our business processes and operations, which requires information that is accurate, complete, consistent and, above all, secure. This makes cyber security one of West’s most important priorities.</span>
<p style="margin: 0in 0in 0pt;"><span>Every day, all day, safety matters. Safety never takes a day off. All around us we see safety warnings such as allergens on food labels, use-by-dates on milk and expiration dates on medications. There is no substitute for doing things safely. For pharmaceutical and biotechnology companies offering parenteral drug products, patient safety is the utmost concern.</span></p>
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