In an interview with PerceptivX, Penelope shares exclusive insight on her background and why it’s high time to revolutionize regulatory compliance strategy in the pharmaceutical industry. She also spoke about the importance of leading authentically, overcoming fears to achieve goals and things she’d like most to change about the world.
Penelope Przekop is a is a biopharmaceutical quality assurance and corporate compliance executive consultant with global R&D and commercial PV expertise. During the early 2000s, she developed and oversaw the first global PV quality and compliance departments established for Wyeth as well as Johson & Johnson. Her work includes qualification and oversight of numerous PV vendors covering all aspects of clinical safety and post-marketed PV. Penelope has facilitated numerous PV regulatory inspections. She frequently leads and conducts PV mock inspections and provides in-depth PV training.
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In clinical research, perhaps our oldest code we live by is the Hippocratic oath. Our industry is more complicated today than ever before, so how can we remain loyal to our shared code while also supporting the innovative solutions and approaches of the modern world?
In clinical research, perhaps our oldest code we live by is the Hippocratic oath. Our industry is more complicated today than ever before, so how can we remain loyal to our shared code while also supporting the innovative solutions and approaches of the modern world?
There is a growing industry focus on standard operating procedure (SOP) remediation. Although outsourcing, mergers, and acquisitions have been in play for the last 20 years, these activities seem to be skyrocketing, which is creating quite a few scenarios that drive the need for SOP remediation.
There is a growing industry focus on standard operating procedure (SOP) remediation. Although outsourcing, mergers, and acquisitions have been in play for the last 20 years, these activities seem to be skyrocketing, which is creating quite a few scenarios that drive the need for SOP remediation.
We discuss three essentials for designing a compliance strategy to ensure patient safety and data integrity throughout the decentralized drug development process.
We discuss three essentials for designing a compliance strategy to ensure patient safety and data integrity throughout the decentralized drug development process.
The ultimate purpose of sponsor oversight is to act when required. Audits, meetings, and documentation are not always enough. Too many sponsors seem to be forgetting that they are the customer; one that’s paying a heavy price for services that can ultimately make or break them. Reset the industry balance with these 3 best practices.
The ultimate purpose of sponsor oversight is to act when required. Audits, meetings, and documentation are not always enough. Too many sponsors seem to be forgetting that they are the customer; one that’s paying a heavy price for services that can ultimately make or break them. Reset the industry balance with these 3 best practices.