Global biopharma regulations and guidelines require that individuals involved in conducting clinical trials be qualified by a combination of education, training, and experience. The components are straightforward to implement regarding internal employees, but not so clear when it comes to part-time consultants contracted to intermittently execute specific good clinical practice (GCP) tasks. Discover three trips for training independent consultants.
3 Essentials For A Fit-For-Purpose Compliance Strategy In Decentralized Pharma
We discuss three essentials for designing a compliance strategy to ensure patient safety and data integrity throughout the decentralized drug development process.
About the Author

Penelope Przekop, CEO
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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Global biopharma regulations and guidelines require that individuals involved in conducting clinical trials be qualified by a combination of education, training, and experience. The components are straightforward to implement regarding internal employees, but not so clear when it comes to part-time consultants contracted to intermittently execute specific good clinical practice (GCP) tasks. Discover three trips for training independent consultants.
The clinical quality management systems approach developed 20 years ago is not sustainable in the today's industry because we've seen dramatic industry changes in outsourcing, remote monitoring, the use of electronic systems in clinical research, and more. But how do we update our approach for 2022 pharma? This article examines 4 imperatives, including how to accomplish them.
The clinical quality management systems approach developed 20 years ago is not sustainable in the today's industry because we've seen dramatic industry changes in outsourcing, remote monitoring, the use of electronic systems in clinical research, and more. But how do we update our approach for 2022 pharma? This article examines 4 imperatives, including how to accomplish them.
Find out the reasons why our industry, your company, and employees should value the unique skillset of the quality and compliance professionals more than ever in decentralized pharma.
Find out the reasons why our industry, your company, and employees should value the unique skillset of the quality and compliance professionals more than ever in decentralized pharma.
Qualio recognizes PDC Pharma Strategy as the top 1 pharmaceutical consulting firm one should consider for 2024.
Qualio recognizes PDC Pharma Strategy as the top 1 pharmaceutical consulting firm one should consider for 2024.