Tuesday, 20 November 2018Bill Buzzeo, General Manager, U.S. Center of Compliance Excellence, IQVIA
Today’s drug and medical device manufacturers have several common challenges. First, nearly all are being impacted by the shifting global regulatory compliance environment as they simultaneously strive to stay ahead of the competition while safely and effectively meeting the needs of patients. Additionally, compliance has typically been seen as a department, not a shared responsibility, and collectively perceived as a cost center, not a value center.
Friday, 16 November 2018Florian Czaszewicz, Industry Solutions Consultant, Pilgrim Quality Solutions, an IQVIA company
The American Society for Quality, touted as the “Global Voice of Quality,” states that manufacturers in the pharmaceutical industry are always working to balance the demands of meeting global regulations and production costs, in an effort to produce the most innovative research and development while also producing safe, reliable prescription drugs
. As a biopharmaceutical industry veteran, I know the challenge is real. In fact, when illustrating a graphic representation of the Biopharma industry’s information management landscape, as I see it, the depiction is quite dense and complex.
Friday, 26 October 2018Dan Jacob, Research Director, LNS Research
Pilgrim Quality Solutions last month hosted an enjoyable, inspiring, and valuable global customer conference, Fusion 2018, in Tampa, Florida. This year's conference provided an opportunity for attendees to learn about Pilgrim’s strategy to drive the Next-Generation Quality vision, and to share the exciting benefits that Pilgrim, now as part of IQVIA Technologies, can provide to its customers.
Friday, 19 October 2018Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company
Supply chain risks grow as an organization’s suppliers expand geographically and companies increase offshoring and outsourcing activities. The increasing sophistication in technology, and ever-increasing regulatory oversight, are additional factors in the increased supply chain risk
. Resulting supply chain issues are impacting medical device
manufacturers around the globe, costing billions of dollars in market devaluations, recalls, regulatory fines, and settlements. But supplier management is a viable tool in the arsenal to minimize the risk of those outcomes.
Tuesday, 16 October 2018Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company
Ask any corporate executive to list the top objectives of their organization’s Quality department and they’ll include the need for predictive and proactive risk management strategies. The Medical Device industry is no exception to this reality; if the industry wants to improve patient outcomes, then it has to manage risk.
One of the largest sources of organizational risk is dependence on third-party suppliers. Today’s global economy has added complexity to supply chains, and longer supply chains are making it increasingly difficult to manage our suppliers
, and in many cases our suppliers’ suppliers, thereby increasing overall risk. The plethora of medical device regulatory requirements placed in Medical Device
organizations, including FDA mandates and the updates to ISO 13485:2016, reflect this new reality.