New Online Course on "The Pharmacovigilance Audit: How to Prepare for an Inspection" Offers Crucial Training Amid Recent EMA Warnings on Topiramate Use in Pregnant Women

Dublin, Sept. 05, 2023 (GLOBE NEWSWIRE) -- In light of the recent European Medicines Agency’s safety committee recommendation against the use of topiramate-containing medicines in pregnant women, the importance of rigorous pharmacovigilance practices has never been more evident. The committee's findings underscore the critical role of safety inspections in ensuring drug safety, as well as the need for companies to be fully prepared for these inspections.

To help pharmaceutical firms navigate this complex regulatory landscape, is pleased to announce the launch of an online training course titled "The Pharmacovigilance Audit: How to Prepare for an Inspection." This timely course is designed to prepare companies for the stringent demands of pharmacovigilance inspections conducted by regulatory authorities such as the FDA in the United States and EMA in Europe.

About the Course

The course will offer hands-on training on how to prevent common issues identified during inspections for drug safety and pharmacovigilance. With specific examples based on the top ten findings by US and EU pharmacovigilance inspectors, participants will gain actionable insights into how to improve their current safety practices and avoid regulatory complications.

Key topics covered in the course include:

  • The top ten findings from US and EU pharmacovigilance inspections
  • Importance of pharmacovigilance audits in ensuring Good Pharmacovigilance Practice
  • Impact of global regulations on international safety reporting
  • Practical steps to initiate and implement audits
  • Do’s and don’ts during inspections
  • And much more

Who Should Attend?

This course is ideal for pharmaceutical professionals planning internal audits, anticipating audits from business partners, or those preparing for an FDA or EMA inspection. Whether you're a seasoned veteran or new to the field, this course will provide the tools needed to ensure compliance with drug safety and pharmacovigilance regulations.

Qualification and Accreditation

Upon completion, participants will earn 3.0 RAC credits. This course has been pre-approved by the Regulatory Affairs Professional Society (RAPS) as eligible for these credits towards a participant's RAC recertification.

Why This Course is Important Now

The recent recommendations by the European Medicines Agency’s safety committee about the use of topiramate-containing medicines highlight the critical need for robust pharmacovigilance systems. Companies not only need to comply with existing regulations but must also be prepared to adapt to new safety findings to protect patient health.

Don't leave your pharmacovigilance practices to chance. Ensure your company is prepared to meet the high standards set by regulatory bodies. Enroll in "The Pharmacovigilance Audit: How to Prepare for an Inspection" course today and equip yourself with the knowledge and skills to face the challenges of regulatory scrutiny confidently.

News Source: Reuters

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