How Biopharma Leaders Can Ward Off A Perfect Storm: Part 1
Senior biopharma executives can strategically ward off this storm’s potential impact to our industry provided they are fully informed.
Learn more
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.
About the Author
Penelope Przekop, CEO
MSQA, RQAP-GCP
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.
Related Content
Read more from PDC’s teams of experts.
How Biopharma Leaders Can Ward Off A Perfect Storm: Part 1
Senior biopharma executives can strategically ward off this storm’s potential impact to our industry provided they are fully informed.
Learn more
6 Novel Mock BIMO Regulatory Inspection Exercises
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).
Learn more
6 Novel Mock BIMO Regulatory Inspection Exercises
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).
Learn more
Why Sponsor Awareness Cannot Be "Day Zero" For SUSAR Reporting (2)
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.
Learn more
Why Sponsor Awareness Cannot Be "Day Zero" For SUSAR Reporting (2)
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.
Learn more
How Biopharma Leaders Can Ward Off A Perfect Storm: Part 2
Amid all this financial and operational strategizing, a huge puzzle piece is often left to the side: compliance.
Learn more
How Biopharma Leaders Can Ward Off A Perfect Storm: Part 2
Amid all this financial and operational strategizing, a huge puzzle piece is often left to the side: compliance.
Learn more