Developing storyboards for regulatory inspection readiness and facilitation is a growing trend, yet the tool is shrouded in mystery for many pharma industry professionals. Storyboarding is a powerful approach for boiling down your company’s unique drug development journey into compartmentalized, positive short stories or messages that clarify pivotal points in time or scenarios. They provide a framework for creating clear messaging that can be consistently communicated by the inspection team. This is particularly needed for situations when opportunities for company growth, mitigation of existing gaps, and/or other unique compliance scenarios were self-identified and action was taken to ensure compliance and enable forward movement. They ultimately serve to remove confusion, contradiction, and on-the-spot decision-making when addressing inspection questions about the most difficult, convoluted aspects of your product’s drug development story. All companies have those; you are not alone.
3 Reasons Why Sponsors Must Review Monitoring Reports
Despite recent progress in executing and documenting oversight, sponsor oversight remains a challenge, especially with monitoring reports. Penelope Przekop detail three reasons why they must remain top of mind.
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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Developing storyboards for regulatory inspection readiness and facilitation is a growing trend, yet the tool is shrouded in mystery for many pharma industry professionals. Storyboarding is a powerful approach for boiling down your company’s unique drug development journey into compartmentalized, positive short stories or messages that clarify pivotal points in time or scenarios. They provide a framework for creating clear messaging that can be consistently communicated by the inspection team. This is particularly needed for situations when opportunities for company growth, mitigation of existing gaps, and/or other unique compliance scenarios were self-identified and action was taken to ensure compliance and enable forward movement. They ultimately serve to remove confusion, contradiction, and on-the-spot decision-making when addressing inspection questions about the most difficult, convoluted aspects of your product’s drug development story. All companies have those; you are not alone.
Over the last 10 years, the face of clinical research & development (R&D) and pharmacovigilance (PV) outsourcing has dramatically changed. What was a common industry scenario by 2010 — a full-scale operational pharma company utilizing both international and U.S.-based contract research organizations (CROs) to execute clinical investigator site monitoring and data management — has evolved into a new common scenario in 2019. More than ever, we see what I call a stick-figure pharma company (just the bones) utilizing vendors to execute as many of the required drug development processes as they possibly can. In fact, it’s not surprising to see a company using multiple vendors for the same process, such as regulatory reporting of expedited adverse event cases, investigator site monitoring, multiple types of auditing, and manufacturing. In my consulting work, I meet and interview numerous pharma employees at all levels who struggle when asked to explain how their stick-figure company connects with all the good clinical practice (GCP) and good pharmacovigilance (GVP) practice vendors in play.
Over the last 10 years, the face of clinical research & development (R&D) and pharmacovigilance (PV) outsourcing has dramatically changed. What was a common industry scenario by 2010 — a full-scale operational pharma company utilizing both international and U.S.-based contract research organizations (CROs) to execute clinical investigator site monitoring and data management — has evolved into a new common scenario in 2019. More than ever, we see what I call a stick-figure pharma company (just the bones) utilizing vendors to execute as many of the required drug development processes as they possibly can. In fact, it’s not surprising to see a company using multiple vendors for the same process, such as regulatory reporting of expedited adverse event cases, investigator site monitoring, multiple types of auditing, and manufacturing. In my consulting work, I meet and interview numerous pharma employees at all levels who struggle when asked to explain how their stick-figure company connects with all the good clinical practice (GCP) and good pharmacovigilance (GVP) practice vendors in play.
Small to midsize pharmaceutical or biotech companies (small pharma) are enjoying the best of times. Many have exciting products with fantastic preclinical and/or clinical results, great platforms for long-term company growth and licensing possibilities, outstanding medical and technical expertise, and support from intellectual/academic experts. However, from a quality systems perspective, it could be the worst of times. Many have weak quality systems, are not following global regulatory authority regulations and/or guidance, or lack the level of documentation required to reconstruct every aspect of clinical trials.
Small to midsize pharmaceutical or biotech companies (small pharma) are enjoying the best of times. Many have exciting products with fantastic preclinical and/or clinical results, great platforms for long-term company growth and licensing possibilities, outstanding medical and technical expertise, and support from intellectual/academic experts. However, from a quality systems perspective, it could be the worst of times. Many have weak quality systems, are not following global regulatory authority regulations and/or guidance, or lack the level of documentation required to reconstruct every aspect of clinical trials.
Now that we have years of real-world regulatory outcomes data available, why are we ignoring their power to serve as a corrective lens for our interpretations of the law?
Now that we have years of real-world regulatory outcomes data available, why are we ignoring their power to serve as a corrective lens for our interpretations of the law?