The Future of Pharmaceuticals

The Future of Pharmaceuticals

IQVIA

It is an exciting, and formidable, mandate – to solve the world’s healthcare challenges. To continually find new ways of delivering value and real outcomes to patients, providers, and payers. To rise to the challenge to be more precise, from clinical trials to commercialization. To make the most out of increasingly limited resources. And to minimize while maximizing success. That is what IQVIA, the Human Data Science Company, is about.

(more…)
The Compliance Roadmap

The Compliance Roadmap

Mark Scallon, Senior Principal, Commercial Compliance, IQVIA

As regulatory changes continue in the EU and the U.S., life sciences companies will need to focus more on rigor and reproducibility with respect to non-clinical, pre-clinical, clinical data, and post-market data, in addition to the subsequent documentation and audit challenges. (more…)

Transform Your Approach to Compliance From Concept to Market

Transform Your Approach to Compliance From Concept to Market

Bill 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. (more…)

Supplier Risk and its Impact on Corporate Risk

Supplier Risk and its Impact on Corporate Risk

Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company

Risk continues to be a major focus in most businesses today, regardless of industry. In the past few years, Life Sciences organizations have seen a steady rise in supply chain issues resulting in lost market caps, recalls, regulatory fines, and other financial impacts valued in the billions of dollars. Subsequently, the standards organizations and regulators around the globe have taken note and responded accordingly. So it’s no surprise that minimizing business and operational risks, as well as legal and regulatory compliance, is on every executive’s mind, and for good reason.

Supplier risk, put simply, is the probability associated with a supplier causing an interruption in an organization’s supply chain by impacting the availability of products and services within that supply chain. Supplier impact, at a minimum, effects two legs of the three-legged Governance, Risk, and Compliance (GRC) stool: those two legs are Risk and Compliance. The impact of suppliers on an enterprise can be significant. (more…)

Quality within the BioPharma Industry Landscape

Quality within the BioPharma Industry Landscape

Florian 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. (more…)

A Deviation by Any Other Name

A Deviation by Any Other Name

Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company

What’s in a name? Depending on industry, a word can have very precise meaning. Look up the word “deviation” on the internet and the first definition to appear reads: noun, The action of departing from an established course or accepted standard. Statisticians use the term to define “The act of deviating” or “Deviation from a norm”.

If you search for the definition of “deviation” as applied in the Pharmaceutical industry, you’ll find some variation of “Unexpected departure from an approved instruction, procedure, established standard or specification.” In other words, “deviation” is not a desirable term in the Quality lexicon. (more…)

Continuing Education in the Quality Space

Continuing Education in the Quality Space

Lynn Willis, Partner Enablement and Training Manager, Pilgrim Quality Solutions, an IQVIA company

An important facet of any organization’s quality efforts is the knowledge of its personnel. The depth of each employee’s knowledge and skills contributes to the company’s ability to achieve its mission and goals. Conversely, employees who do not have the knowledge to perform their day-to-day functions pose a quality risk. This equation applies as much to long-time employees as to new hires. (more…)

Limit the Stakes with Risk-Based Employee Training

Limit the Stakes with Risk-Based Employee Training

Lynn Willis, Partner Enablement and Training Manager, Pilgrim Quality Solutions, an IQVIA company

Employees often know little about product liability and the role they have in the company’s overall risk profile. The acts or omissions of even one employee can have severe financial and operational consequences for companies. Employee risk management training is essential to bridging the awareness gap.

With the adoption of ISO 13485:2016, Life Sciences manufacturers have stepped up their risk-based training requirements. What about your organization? How do you currently define training requirements? If you’re not considering risk as you define them, you will need to add this consideration into your process. (more…)

Quantify Risk to Boost CAPA Efficiency

Quantify Risk to Boost CAPA Efficiency

Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company

Corrective and Preventive Action (CAPA) systems provide a wealth of information regarding the quality of a product or process. However, few companies fully leverage the power of this tool to realize its positive impact to the bottom line.

For instance, it is not uncommon for a CAPA to be initiated for each product quality-related complaint regardless of scope or severity. Over time, the system becomes laden with records of varying degrees of severity, which are often vetted by issuance order for aging reasons, rather than priority. As a result, the organization cannot optimally allocate resources to correct events that have the most impact on the business as a whole. (more…)

Distinguish Yourself with Risk-based Supplier Inspections

Distinguish Yourself with Risk-based Supplier Inspections

Roxane Napoli, Associate Director and Product Marketing, IQVIA Quality Compliance Solutions

Optimization of your supplier quality management processes gives you room to differentiate yourself from your competitors and gain advantages in your industry. Optimization alone, however, does not happen without regard for potential risks inherent within complex supply chains or ever-evolving regulatory requirements.

Your organization can distinguish itself from your competitors by circumventing potentially adverse situations before they become realities. Minimizing supplier-related risk will maximize your compliance and quality improvement activities, thereby growing customer trust and brand loyalty which will ultimately increase your organization’s bottom line. (more…)