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Tuesday, April 10 • 1:30pm - 3:00pm
Session D - GCP/PV Track

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D-1  MHRA & FDA Pharmacovigilance Inspection Trends 

This presentation will provide information obtained for the most recent MHRA PV inspection metrics report and the data mining of the FDA warning letters and 483 with regard to PV reporting activities. A comparison will be made between the agency observation outcomes and trending over the last three available years with advice as to what audit areas should be focused on by PV auditors based on both regional and global expectations.


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D-2   Demystifying Pharmacovigilance Auditing 

Word on the street is that Pharmacovigilance auditors are golden. This presentation will demystify PV auditing and explain the similarities and differences it has with the types of audits for which most QA professionals are familiar. Key elements of a PV audit will be shared along with advice and tips on how to apply existing QA knowledge and skills to PV auditing. There seems to be a shortage of quality assurance professionals with solid PV experience. A great number of QA auditors learned the tricks of our trade in clinical QA departments, spending a significant amount of time conducting investigator site audits. Many have spent entire careers in QA and not so much time in operational roles that provide on-the-ground, operational experience in various aspects of the drug development process, including PV.  Pharmacovigilance is a key piece of the drug development process that not only continues but picks up momentum after market approval. Following the rise of the European focus on quality systems and publication of the European Medicines Agency (EMA) GPV Modules, global attention on PV has escalated, causing Sponsors to turn to QA professionals for guidance. It's in the best interest of QA professionals to jump in and learn as much as possible about PV compliance and auditing so that we can meet the needs of our customers and enhance our ability to impact patient safety.


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D-3  An Observation in Time Saves Nine 

Clinical research is a process driven activity.  Some processes are performed in parallel, some are performed in sequence; some intersect whereas others are independent of one another.  Whenever process steps are in sequence we have significant opportunities to identify up stream, high value critical control points that when used in risk based planning and auditing can:
  • reduce rework and corrective actions throughout the life of the trial,
  • enhance risk driven planning and “monitoring”,
  • provide a more efficient submission development process, and
  • ultimately contribute to regulatory confidence in patient safety and data integrity
As risk-based auditing becomes a more common area for consideration, situations that allow for identification of these high-value, critical control points should be factored into integrated risk plans and assessments, ensuring sufficient resources are devoted to their “monitoring” and evaluation.  At these critical control points, timely, high-value observations are like templates: you identify errors early and quickly, and the entire trial can benefit.  The trial maintains a potentially otherwise unrealized uniformity and consistency.
Technology provides us with the tools for attaining such uniformity.  But it is not the tools per se, it is the thought processes of those who recognize the nature of particular negative risk outcomes stemming from a particular critical control point that can make the difference between efficient clinical research infrastructure and electronic window dressing.
Examples will be provided from database development, data management and clinical monitoring can prevent errors from occurring and multiplying across a trial.

Good Clinical Practices

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Milind Nadgouda

RiverArk Ltd.

avatar for Dorcie Jasperse

Dorcie Jasperse

Raland Compliance Partners, LLC
Dr. Dorcie Jasperse has over 30 years of experience in clinical trials and medical research. Working in the government, academic, and commercial settings as a data manager, statistician and epidemiologist, project and program manager, GCP auditor, and manager of GMP auditors.In her... Read More →
avatar for Penelope Przekop

Penelope Przekop

CEO/Principal Consultant, PDC Quality Consulting
Penelope Przekop is an outcome-driven Senior Executive and Thought Leader with more than 25 years of success across the biotech, pharmaceutical, healthcare, teaching hospital, clinical trials, manufacturing, and design industries. Her broad areas of expertise include quality assurance... Read More →
avatar for Vaska Toné

Vaska Toné

CEO / Founder, LaVaPharm Consulting LLC
Vaska Tone is an independent international QA consultant and the founder of LaVaPharm Consutling with offices in the US and Europe. She has been in QA since 1994 performing global audits from GLP through to Post-Marketing PV audits. She is passionate about continual learning and speaks... Read More →
avatar for Miguel Zamora

Miguel Zamora

Miguel Angel Zamora is an accomplished, high-energy Director of Quality Operations with more than 20 year of global experience in a wide range of markets across biotech, pharmaceuticals, medical devices, cosmetics and manufacturing.His broad experience include Quality Management development... Read More →

Tuesday April 10, 2018 1:30pm - 3:00pm PDT
Platinum 7&8