Changes to Good Pharmacovigilance Practices in the EU

Speaker

Instructor: Robert J Russell
Product ID: 702341

Location
  • Duration: 90 Min
This 90-minute webinar will provide you a thorough understanding of the updated framework surrounding Good Pharamcovigilance Practices (GVP) in the EU. This will include updates to the EU regulation, Directive and the first seven PV Modules, which have been published for consultation.
RECORDED TRAINING
Last Recorded Date: Jul-2012

 

$229.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

$299.00
Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
(For multiple locations contact Customer Care)

 

 

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Fax: +1-650-362-2367

Email: [email protected]

Read Frequently Asked Questions

Why Should You Attend:

This webinar is focused on understanding the new requirements for Good Pharmacovigilance Practices that will begin to become effective in the European Union beginning July 2012.

The New Guidance on Good Pharmacovigilance Practices (GVP) has been updated by Module, of which the first seven Modules have been disclosed for public consultation. This course will describe the Regulatory Updates, Guidance Updates and thoughts on how some Member States’ Competent Authorities will proceed with implementation. These regulatory changes will also impact the EU Clinical Trial Directive and expectations of sponsors in the protection of patients and public health, before, during and after a clinical study.

Learning Objectives:

Upon completion of this course, attendees will have a thorough knowledge of the updated framework surrounding Good Pharamcovigilance Practices (GVP). This will include updates to the EU regulation, Directive and the first seven PV Modules, which have been published for consultation. The content of this course is designed to simplify the understanding of the new requirements and to provide attendees with the latest information on what the European Commission believes is a significant area of improvement in the region.

Key Topics to be Discussed:

  • Pharmacovigilance systems
  • Reporting and Management of Adverse Reactions
  • Periodic Safety Update Reports
  • Post Authorization Safety Studies
  • Changes to Definitions
  • The Pharmacovigilance Risk Assessment Committee

Detailed Agenda of Session:

  • Overview of EU Regulatory structure.
  • EU Pharmacovigilance : Why make changes now?
  • New definitions for the updated directive and regulation.
  • Organization of PV Modules.
  • Update to the EU Pharmacovigilance legislation.
    • How the new legislation will better protect patient safety
    • How the new legislation will affect Marketing Authorization Holders
    • How the new legislation will affect Sponsors of Clinical Studies
    • Adverse Drug Reaction Reporting
      • Periodic Safety Update Reports
      • Post-Authorization Safety Studies
    • Eudravigilance Database
    • Changes to labeling
    • The Pharmacovigilance Risk Assessment Committee
    • Implementation timing & expectations

Who Will Benefit:

This Webinar will provide invaluable assistance to all personnel in the Pharmaceutical, Biotechnology and CRO industry involved in maintaining Compliance across the responsibilities in European Pharmacovigilance such as:

  • Senior Management
  • Project Managers
  • Clinical Trial Heads
  • PV Reporting
  • Medical Writers
  • CRAs and CRCs
  • QA / Compliance personnel
  • Investigators
  • Clinical Research Scientists
  • QA / QC Auditors and Staff
  • Consultants

Instructor Profile:

Robert J. Russell , is President and CEO of RJR Consulting, Inc, a leading Global Regulatory Consulting firm focusing on assisting the Life Science Industry. Prior to founding the firm in 2000, Mr. Russell had over 27 years of experience in CMC, Global Business Development and Regulatory Compliance for pharmaceuticals, biologics, medical devices and combination products. The company has an office in Brussels, Belgium where they interact with the European Commission and the Competent Authorities across the EU. Country establishment, marketing authorizations, variations and license renewals are core competencies of the course director. Mr. Russell has received a B.S. and M.S in Chemistry.

Topic Background:

New Legislation & Guidance for Pharmacovigilance will apply in the European Union (EU) beginning July 2012. To assist in its implementation with sponsors, applicants and license holders, a series of Guidance Documents is being written, which will replace the current set of Volume 9A of the Rules Governing Medicinal Products in the EU. The legal framework for pharmacovigilance on Medicinal Products for Human Use has now been updated, through an amended EU Regulation (No 1235/2010) and Directive (2010/84/EC).

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Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).

 

 

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