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Do you want to better understand how to navigate the regulatory pathway to successfully bring a drug/device combination product (CP) to market? Understanding that many have this question, West, in collaboration with the Delaware Valley Chapter of PDA, sponsored the symposium (Sep 23): The Evolving Landscape for Combination Products – Defining a Regulatory Strategy. Experts from the industry and the FDA presented and discussed the latest best practices.
During the event, we surveyed more than 200 attendees. One of the questions was: What are the top issues that you are facing? The highest responses were:
From the discussion, it was clear that appropriate testing programs which are risk-based and built to inform the combination product development process are key to assuring that a development program will satisfy global regulatory agencies. There are some key themes to remember when developing any drug device combination product. They are:
Over 29% of the attendees reported struggling with lifecycle management. To provide greater support and insight, West is sponsoring a free webinar (Dec 3, 11:00 AM, EST): ICH Q12 Pharmaceutical Product Lifecycle Management and the Relevance to Combination Products. An overview and specific examples will be discussed.
In the pharmaceutical industry, safety and quality are paramount. One critical aspect of ensuring the safety of pharmaceutical products is extractables and leachables (E&L) testing. This testing process examines the potential migration of substances from containers, packaging materials, and drug delivery systems into the drug products themselves. By understanding the reasoning behind E&L testing, we can appreciate its role in protecting public health and enhancing customer trust. West Pharmaceutical Services, Inc. is a leader in developing comprehensive studies to evaluate container closure systems in real world simulations, providing customers with a better understanding of their leachable profile and how that could affect drug stability.
West is honored to be a recipient of the 2020 Faces of Philanthropy Award from the Philadelphia Business Journal. The Faces of Philanthropy Awards honor partnerships between corporations and nonprofit organizations in the Philadelphia region as they work together to deliver impactful philanthropic initiatives.
While you won’t see cats on vacuums, cute dogs doing crazy tricks or any dancing toddlers, the <a href="http://www.youtube.com/user/WestFYI"><span style="color: #0000ff; text-decoration: underline;">WestFYI YouTube Channel</span></a> does offer a variety of product videos to help customers and potential customers learn more about West’s products and our company.
In 2014, the West Women Investing and Networking (WIN) initiative was born under the leadership of Karen Flynn, Sr. VP & Chief Commercial Officer, and a group of female employees at the West U.S. headquarters in Exton.
West is pleased to share a Q&A with Mark McElfresh, Vice President of Operations and Supply Chain at West contract manufacturing, that recently appeared in <em>Manufacturing Leadership Journal.</em><strong> </strong><strong><br></strong>
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