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.
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.
Read more from PDC’s teams of experts.
Part 1 of this article explained that the FDA's goal is to ensure safety not to provide a compliance safety net to sponsors by enabling arbitrary rules around SUSAR reporting timelines. A few readers raised points to justify using sponsor awareness as Day Zero for SUSAR reporting, regardless of when the PI becomes aware. Part 2 addresses those points and why they miss the mark.
Part 1 of this article explained that the FDA's goal is to ensure safety not to provide a compliance safety net to sponsors by enabling arbitrary rules around SUSAR reporting timelines. A few readers raised points to justify using sponsor awareness as Day Zero for SUSAR reporting, regardless of when the PI becomes aware. Part 2 addresses those points and why they miss the mark.
Don't get caught on your heels. Conducting a mock regulatory inspection in preparation for an FDA, EMA, or other regulatory visit is a key industry inspection readiness activity. Explore six new inspection exercises to help your team prepare for the big day(s).
Don't get caught on your heels. Conducting a mock regulatory inspection in preparation for an FDA, EMA, or other regulatory visit is a key industry inspection readiness activity. Explore six new inspection exercises to help your team prepare for the big day(s).
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.
In addition to my career as a pharma industry consultant, I’m a writer. While I don’t claim to be the next Ernest Hemingway, I do consider myself a decent writer. I’ve put in the 10,000 hours of writing Malcolm Gladwell told us it takes to be an expert in his 2008 book, Outliers: The Story of Success . I’ve always had a passion for writing. At 24, I made a serious commitment to become a real “writer.” I dedicated bits and pieces of my free time over the next five years to writing my first novel. During that time, I wasn’t focused on how improving my writing skills might impact my pharma industry career, which was well underway. Now, I know firsthand that all those high school and college English, writing, and literature teachers and professors were right when they told us that excellent writing skills can take us far in any career.
In addition to my career as a pharma industry consultant, I’m a writer. While I don’t claim to be the next Ernest Hemingway, I do consider myself a decent writer. I’ve put in the 10,000 hours of writing Malcolm Gladwell told us it takes to be an expert in his 2008 book, Outliers: The Story of Success . I’ve always had a passion for writing. At 24, I made a serious commitment to become a real “writer.” I dedicated bits and pieces of my free time over the next five years to writing my first novel. During that time, I wasn’t focused on how improving my writing skills might impact my pharma industry career, which was well underway. Now, I know firsthand that all those high school and college English, writing, and literature teachers and professors were right when they told us that excellent writing skills can take us far in any career.