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Nov 11, 2024 | 
clinicalleader.com | Penelope Przekop
By Penelope Przekop, MSQA, RQAP-GCP
In 1962, the U.S. Kefauver-Harris Drug Amendments included a key new provision requiring that, in addition to the pre-market safety demonstrations mandated by the 1938 Food, Drug, and Cosmetic Act, new drugs demonstrate efficacy prior to marketing. This provision required controlled trials to substantiate claims of efficacy.
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May 31, 2024 | 
clinicalleader.com | Seema Verma |Penelope Przekop
Webinar: How New Technologies are Transforming Pharmacovigilance and Improving Patient SafetyJoin speakers from Incyte, Oracle, Optimapharm and PharmaLex to explore how new technologies are making safety processes faster and more accurate - freeing safety and clinical teams while enhancing patient safety.
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Feb 23, 2024 | 
clinicalleader.com | Penelope Przekop |Beth Harper
Webinar: Do Mobile Visits Drive Faster Study Results? Join us on February 27 to learn how to better address crucial challenges in today's drug development landscape, including patient dropout rates. We'll help you understand the value of both experience and expertise in delivering successful mobile nurse visits and analyze their impact on shortening clinical trial timelines. Click here to learn more.
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Feb 20, 2024 | 
clinicalleader.com | Penelope Przekop
By Penelope Przekop, MSQA, RQAP-GCP
Representatives from the FDA and industry sponsors, vendors, professional organizations, patient advocates, and academic think tanks gathered at the U.S. Press Club in Washington, D.C. to discuss challenges and successes of integrating quality by design (QbD) and risk-based monitoring (RBM) into the design and conduct of clinical studies.
On Jan.
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Jan 5, 2024 | 
clinicalleader.com | Penelope Przekop |Doug Shaw |Karen Travers |Ed Drower
Why Sponsor Awareness Cannot Be "Day Zero" For SUSAR ReportingIn Part 1, we highlighted the FDA's focus on safety, not serving as a compliance safety net for sponsors through arbitrary rules on SUSAR reporting timelines. Part 2 delves into reader-raised justifications for using sponsor awareness as Day Zero for SUSAR reporting, exploring why these arguments fall short.
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Dec 15, 2023 | 
clinicalleader.com | Penelope Przekop |Ivy Weng |Doug Pierce
Despite an abundance of “e” technologies designed to streamline various elements of the clinical trial process, many sites still rely on paper-based systems. Join the next Clinical Leader Live, where we'll discuss some possible reasons for this conundrum and which technologies are helping and increasing in adoption. Registration is free thanks to the support of YPrime.
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Dec 5, 2023 | 
clinicalleader.com | Penelope Przekop
By Penelope Przekop, MSQA, RQAP-GCP
Following the May 19, 2023 ICH Assembly endorsement of ICH E6(R3) final draft, every sponsor should understand and accept that regardless of delegating GCP tasks, duties, or functions, they retain overall responsibility for the activities. Sponsors have made tremendous progress in executing and documenting oversight in recent years. However, sponsor oversight remains a challenge.
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Aug 16, 2023 | 
clinicalleader.com | Penelope Przekop
By Penelope Przekop, MSQA, RQAP-GCP
This article is a follow-up to Why Clinical Site Awareness Should Be “Day Zero” For SUSAR Reporting.
There is no logic to support that a regulatory agency responsible for patient/consumer safety would agree that the timeline for suspected, unexpected, serious adverse reaction (SUSAR) reporting begins with sponsor awareness regardless of when the PI became aware.
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Jun 1, 2023 | 
clinicalleader.com | Penelope Przekop |Darshan Kulkarni
The DIA 2023 Global Annual Meeting invites industry, regulatory government, academics, and patients to network, problem solve, and discuss global and local challenges facing the life sciences community. Hosted in Boston, DIA 2023 will amplify different perspectives while highlighting expertise across the globe to reimagine current processes that better enhance health and well-being.
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May 3, 2023 | 
clinicalleader.com | Penelope Przekop
Guest Column
| May 3, 2023
By Penelope Przekop, MSQA, RQAP-GCP
The FDA’s goal is to ensure safety, not to give sponsors a compliance safety net. Its acceptance of arbitrary suspected, unexpected, serious adverse reaction (SUSAR) reporting timelines that allow for long gaps in sponsor processing and reporting would be counterproductive to its purpose and goals.
