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.
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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.
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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
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
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
Top 5 Strategies To Execute And Document GCP/GVP Vendor Oversight
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Top 5 Strategies To Execute And Document GCP/GVP Vendor Oversight
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.
Learn more