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.
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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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.
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.
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.
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).
Many sponsors and CROs conduct mock inspections to determine organizational inspection and audit readiness. Investing in a regulatory mock inspection demonstrates a serious commitment to patient safety, data integrity, and regulatory compliance. It is also a proactive strategy to safeguard financial health, particularly for startups and companies with sparse pipelines.
Many sponsors and CROs conduct mock inspections to determine organizational inspection and audit readiness. Investing in a regulatory mock inspection demonstrates a serious commitment to patient safety, data integrity, and regulatory compliance. It is also a proactive strategy to safeguard financial health, particularly for startups and companies with sparse pipelines.