Pharma

Training Courses | Online Live Stream

Pharmacovigilance Inspections & Audits Updates

This course is not currently scheduled but may be offered at your company site.
Please contact Fleming for more information.

Pharmacovigilance Inspections & Audits Updates

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.

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Training

Brochure

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

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

Testimonials

Sue Rees is an excellent trainer, providing a comprehensive overview of requirements and experiences in audit and inspections.

Very informative and interactive, nice atmosphere, excellent organization.

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.

I enjoyed the training. Extremely happy with EU and US comparison in regards to legislation and inspection findings.

Registration

Training ticket

This course is not currently scheduled but may be offered at your company site.
Please contact Fleming for more information.

Online Live Stream

FROM

1496€

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Contact us

Andrea Weber

Sr. Manager for Pharma

Phone: +421 257 272 100

Email: event.inquiries@fleming.events

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Pharmacovigilance Inspections & Audits Updates