Vendor Oversight – The implications of FDA Bioresearch monitoring manual update to Sponsors and CROs

Speaker: Liz Wool, President & CEO of Wool Consulting Group, Inc  

Moderator: Dave Webber, Strategic Partnerships, Janssen

January 25th 15:00 – 16:00 CET

Zoom – online event

What is FDA Chapter 48 Bioresearch Monitoring Manual, and why should you know all about it?

What does it matter to EU-based sponsors?

What are the requirements for documenting CRO selection and management and what are the inspectors looking for?

Join Dave Webber, Strategic Partnerships, Janssen and Liz Wool, President & CEO of Wool Consulting Group, Inc  on January 25th 15:00 – 16:00 CET at the first PCMG fireside chat, and get the answer to these and other questions.

The event is open to Sponsors and Suppliers – PCMG membership not required

Bring some friends and join the discussion!

About Liz Wool

  • Research Nurse, Johns Hopkins Hospital, Baltimore, MD USA
  • International Clinical Research Trainer and Consultant with over 25 years experience: clinical operations, training design & delivery, training strategies and infrastructure, trial management, quality, compliance, vendor management, procedural documents-process mapping, quality management systems
  • Establish/Refine Organizations Vendor Management Framework and Training Programs
  • Invited speaker on CRO-Vendor Management: DIA, ACRP, ExL Conferences US and EU (now Questex)
  • Fellow, ACRP (FACRP) 2020 – present (ACRP)
  • Certified Clinical Research Associate (CCRA) 2000 – present (ACRP)
  • Distinguished Author: Training, Quality Management Systems, Metrics in Clinical Research, ACRP The Monitor/Clinical Researcher Journal,
  • Thought Leader: Beyond Basic GCP Training, NIH CTSA Meeting
  • Worked With: Biotechnology & Pharmaceutical Companies, CROs, Academic Health Centers, National Institutes of Health (NIH), University Research Administrator Training Program

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