>Global Pharmacovigilance Regulatory Requirements: What’s New?

  • Venue: Central London
  • Date: 06 Jun - 07 Jun 2018
  • Cost per delegate:
    • Or £775 + VAT academic

      (academic units, public sector organisations, registered charities)

    • Or £1190 + VAT standard

      (standard registration fee)

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IntroductionGlobal Pharmacovigilance

In our global pharmacovigilance market the legislation requires the Marketing Authorisation Holder (MAH) of medicinal products to have a pharmacovigilance system where all aspects comply with the requirements of the appropriate regulatory authority. As more MAHs work globally it is increasingly important that they understand local differences in requirements for compliance around the world including inspection procedures and legal implications. Our Global Pharmacovigilance Regulatory Requirements: What’s New? course brings together a panel of international experts from industry, regulatory and legal backgrounds to provide up-to-date information on all aspects of compliance in pharmacovigilance (both pre-marketing and post-marketing) for Europe, the USA, Latin America, Russia, Africa and Japan including inspection and legal implications.

This course is aimed at:
• Pharmaceutical industry personnel from areas including drug safety, clinical research, medical affairs,medical writing, regulatory affairs 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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“It was interesting to learn about PV regulations in Japan, US, Africa and Latin America and how this differs from the EU regulations. I really liked the wealth of experience and knowledge of the presenters.” Global Regulatory Pharmacovigilance Environment Delegate 2016

“Very good general overview – right level of detail.” Global Regulatory Pharmacovigilance Environment Delegate 2016

“Excellent presentation topics with good speakers who were willing to share and respond to questions.” Global Regulatory Pharmacovigilance Environment Delegate 2015

“Great course! A lot of information and exposure to insightful speakers. The resources will be very useful.” Global Regulatory Pharmacovigilance Environment Delegate 2015

“Excellent mix of presentations and very well-skilled speakers which achieved the expected goal. Excellent organisation.” Global Regulatory Pharmacovigilance Environment Delegate 2015

– To critically appraise current drug safety and pharmacovigilance rules and processes, regulatory trends, and expectations for compliance
– To prepare for pharmacovigilance regulatory inspections through critical evaluation of the rules, regulatory expectations, and common mistakes
– To assess safety date exchange procedures between and within relevant stakeholders including regulatory authorities, MAHs, Clinical Research Organisations (CROs) and other parties involved in contractual agreements

Programme features:

– Compliance in the US – how to satisfy the FDA
– Compliance in the EU – a regulator’s perspective
– Good Pharmacovigilance Practice and implications of the EU Pharmacovigilance Legislation
– The QPPV in the EU
– Legal aspects
– The use of Electronic Data standards in supporting compliance
– Compliance in licensing and due diligence
-Preparing for, and surviving, a compliance inspection

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

– Critically review and interpret current rules and guidelines pertinent to ensuring compliance with relevant pharmacovigilance regulations
– Plan and prepare for pharmacovigilance regulatory inspections
– Optimise company procedures and processes subject to regulatory inspection