£350 – £449

Auditing & Post-Marketing Pharmacovigilance Activities Workshop

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£350 – £449

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Auditing & Post-Marketing Pharmacovigilance Activities Workshop

About this Event

Graviton International presents One Day International Certification Virtual Workshop on Auditing & Post-Marketing Pharmacovigilance Activities.

Learning Outcomes:

Regulatory Requirements for Post-Marketing Pharmacovigilance Audits

  • Review legislation and regulatory requirements for conducting audits of pharmacovigilance systems in the post-marketing setting.
  • Understand key agency expectations in Europe and North America.

Risk Assessment & Defining the Pharmacovigilance Audit Universe

  • Determine which systems and organisations should be considered in the audit universe for pharmacovigilance systems.
  • Understand what risk factors should be considered during risk assessment.
  • Review common methods for performing risk assessments.
  • Consider how risk assessments influence audit schedules.

Conduct of Post-Marketing Pharmacovigilance Audits

  • Follow the life-cycle of a pharmacovigilance audit.
  • Review common findings during audits of post-marketing pharmacovigilance systems.
  • Understand how, when and where results of a pharmacovigilance audit should be reported.

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Speaker BIO

Miranda is a highly experienced pharmacovigilance professional conversant with global regulatory requirements in both pre-marketing and post-marketing environments. She is familiar with the needs of small and big pharma, and the challenges of maintaining compliance with constrained budgets.

Miranda started her career in the pharmacovigilance unit at the UK regulatory agency, then spent several years in industry at Roche and Pharmacia & Upjohn. Miranda then spent 14 years providing consultancy services at ICON (CanReg, acquired by Optum, acquired by Mapi, acquired by ICON) as a European Qualified Person for Pharmacovigilance. During her time there she was also responsible for management of European activities and latterly was Vice President, Pharmacovigilance for global activities. Miranda has been an independent pharmacovigilance consultant since 2018.

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