>EU Regulations and Guidelines in Pharmacovigilance

  • Venue: Novotel London West Hotel, Hammersmith, London
  • Date: 21 Mar - 22 Mar 2018
  • Cost per delegate:
    • Or £775 + VAT academic

      (academic units, public sector organisations, registered charities)

    • Or £1190 + VAT standard

      (standard registration)

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EU Regulations and GuidelinesIntroduction

In 2012, new EU pharmacovigilance regulations and guidances became effective in Europe replacing the former Volume 9A rules governing Medicinal Products in the European Union. They describe the structures, requirements, procedures, roles and activities of the various stakeholders. These are detailed for the collection, verification, presentation and interpretation of adverse reports to exchange information within the EU, to monitor safety products on the market in the EU, to proactively manage safety concerns and to guarantee continuous surveillance of the benefit risk profile of such drugs. Our EU Regulations and Guidelines for Pharmacovigilance course will cover the development and requirements of Good Pharmacovigilance Practices (GVP). The course will also cover other aspects of the new legislation and will provide delegates with a professional working knowledge of EU Pharmacovigilance requirements and an overview of the processes and procedures necessary to ensure compliance.

This course is aimed at:
• Pharmaceutical industry personnel from areas including drug safety, clinical research, medical affairs, medical writing, regulatory, and medical information
• Staff from regulatory authorities

Please click here to download the programme.

Please note that the course dates and programme may be subject to change.

The course is recognised by PharmaTrain.

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“Good speakers with excellent knowledge of their subject area. Good anecdotes in the presentations which helped illustrate the points made.” Regulations and Guidelines Delegate 2017

“Well organised with engaging speakers.” Regulations and Guidelines Delegate 2017

“Comprehensive and very informative. Thank you!” Regulations and Guidelines Delegate 2017

“Very good speakers and a lot of interesting topics covered in the 2 days.” Regulations and Guidelines Delegate 2016

“Excellent organisation and precise, detailed presentations.” Regulations and Guidelines Delegate 2015

 

 

  • To explore the law and guidance defining EU Pharmacovigilance requirements including changes in the July 2012 EU PV legislation and issues associated with their current and future interpretation
  • To analyse the operational aspects of case processing, from receipt to electronic reporting, both for individual cases and the construction of aggregate reports required by regulators
  • To review critically, the qualitative aspects of pharmacovigilance system such as quality assurance, audit, compliance, post-authorization safety studies signal detection, risk management and communication
  • To explore critically, the role of the Qualified Person in Pharmacovigilance (QPPV)
  • To analyse the impact of licensing agreements on pharmacovigilance

Programme features:

  • Development of Good Pharmacovigilance Practice (GVP)
  • Timetable for implementation and requirements of GVP
  • Pharmacovigilance System Master Files
  • Update of PSURs, Risk Management Plans and PASS
  • Inspections
  • Reporting of adverse drug reactions

On successful completion of this course delegates should be able to:

  • Analyse and explain the expectations and scope of the EU pharmacovigilance system
  • Choose, justify and assemble the appropriate tools and manage the processes necessary to facilitate regulatory compliance
  • Appraise the role and responsibilities of the QPPV