events
  • Pharma
  • Training Courses | Online Live Stream

Pharmacovigilance Inspections & Audits Updates

featuring case studies on AI in PV by Fraser McCallum & Denny Lorenz

  • 19 – 21 November 2024
  • Online Live Stream | 14:00 CET – 17:30 CET
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Pharmacovigilance Inspections & Audits Updates

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online live

Training features

Fully online

All sessions of this unique course online

Live interaction

Live interaction options between the delegates and trainer

On any device

Available via mobile, tablet or laptop

Course description

With the widespread of digital technologies, automation and the use of artificial intelligence, the unique opportunities & challenges have emerged in the field of drug safety. Pharmacovigilance has undergone rapid regulatory change in recent years, which has resulted in a complex environment for pharmaceutical companies to operate.

This course will provide a comprehensive, yet practical guide to pharmacovigilance audits and inspections best practice to help navigate what is required to demonstrate compliance in a digital era.

meet the training leaders
Sue Rees | Fleming
Linkedin
Sue Rees
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Fraser McCallum | Speaker | Fleming
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Fraser McCallum / Guest Speaker
View trainer bio
Denny Lorenz | Speaker | Fleming
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Denny Lorenz / Guest Speaker
View trainer bio
Training

Brochure

Reveal the full schedule of the training as well as key topics, course objectives, key takeaways, special features, and the trainer bio!

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Pharmacovigilance Inspections and Audits Updates online live training organized by Fleming_Agenda Cover
Pharmacovigilance Inspections and Audits Updates online live training organized by Fleming_Agenda Cover
Pharmacovigilance Inspections and Audits Updates online live training organized by Fleming_Agenda Cover
key training

Topics

Legislative & regulatory background

Inspectional updates from global regulatory agencies

Inspection preparation, conduct & post-inspection activities

AI/ML impact on PV

AI use in PV, human oversight and AI governance

Experience of audit/inspection of AI systems

PSMF maintenance

Critical PV process auditing

Remote audits and inspections – considerations, risks and mitigations

Benefits of attending

  • Learn how to prepare for a PV audit or inspection
  • Understand the legislation underpinning audit and inspections
  • Discuss real life scenarios and case studies on AI use in PV
  • Explore the global environment
  • Gain examples of findings during inspections
  • Get expert insights on audit/inspection of AI systems

Testimonials

Sue Rees is an excellent trainer, providing a comprehensive overview of requirements and experiences in audit and inspections.
Bert van LeeuwenAstellas
Very informative and interactive, nice atmosphere, excellent organization.
Maria TraikovaICON Plc
I thoroughly enjoyed the course, with the variety of topics offered in a relatively short space of time. Sue did a commendable job in keeping the virtual audience engaged with her overall knowledge and passion for the subject matter and by bringing the topics to life with discussion of real scenarios and sharing personal experiences.
Phil MaddisonAstellas
I enjoyed the training. Extremely happy with EU and US comparison in regards to legislation and inspection findings.
Daniela GlancovaAOP Orphan GmbH
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Contact us

Andrea Weber | Marketing Manager | Fleming
Linkedin
Andrea Weber
Sr. Manager for Pharma
Phone: +421 257 272 100
Email: event.inquiries@fleming.events

DOWNLOAD THE BROCHURE AND REVEAL THE FULL PROGRAM DETAILS

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