Global Pharmacovigilance Regulatory Requirements – What’s New?2018-12-10T12:00:24+00:00

Project Description

Global Pharmacovigilance Regulatory Requirements – What’s New?

Course overview

Venue: Wellcome Collection Conference Centre, Central London

Date: 19 Jun – 20 Jun 2019*

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 Asia including inspection and legal implications.

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

 Our courses are recognised by PharmaTrain.

Who should attend?

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

Aims of course

  • 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

Learning Outcomes

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

Key Topics

Programmed 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
  • Latin American regulations and their impact on pharmacovigilance processes: including Mexico, central America and the Caribbean
  • Australia, New Zealand and the Middle East, an overview
  • Russian Pharmacovigilance; is Russia moving in the same direction as Europe?
  • PV in Asia – Getting ready for the future
  • African pharmacovigilance regulations and their impact on global pharmacovigilance processes
  • Legal aspects
  • Compliance in licensing and due diligence
  • Preparing for, and surviving, a compliance inspection

Fees

Cost Per Delegate:

£775 + VAT Academic

(Academic Units, Public Sector Organisations, Registered Charities)

Or

£1190 + VAT Standard

(Standard Registration)

Download Course Programme

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Booking options

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TESTIMONIALS

“Speakers had excellent knowledge in their fields, good discussions and interactions between the participants, well prepared material and supportive overviews”

Global Regulatory Pharmacovigilance Environment Delegate 2018

“The course was very informative and well thought through. I enjoyed all the speakers and their enthusiasm for their topics “

Global Regulatory Pharmacovigilance Environment Delegate 2018

“Great variety of speakers which keeps attention span going.”

Global Regulatory Pharmacovigilance Environment Delegate 2017

“the course covered all aspects of regulations for different countries”

Global Regulatory Pharmacovigilance Environment Delegate 2017

“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

“Excellent mix of presentations and very well-skilled speakers which achieved the expected goal. Excellent organisation.”

Global Regulatory Pharmacovigilance Environment Delegate 2015

Course Leader

Shelley Gandhi – Director

Shelley Gandhi recently joined NDA regulatory science and brings a wealth of experience in the pharmacovigilance arena after being with the MHRA (UK Regulatory Authority) for 19 years. She has extensive knowledge of all European regulatory processes related to monitoring the safety of licensed medicinal products and ancillary devices and has investigated possible risks and has taken appropriate actions to minimise risk to public health through both European and National Committees. Most recently Shelley was the project lead with regards to ensuring the MHRA complies with the new Pharmacovigilance legislation which came into force on 2 July 2012 and before that she was Vigilance and Intelligence Research Group Unit Manager where she led a team of 30 whose primary role is to carry out risk assessment.

Shelley has a BSc Biochemistry, an MSc in Biopharmacy and Post Graduate Certificate in Pharmacovigilance and Pharmacoepidemiology from London School of Hygiene and Tropical Medicine, University of London.

Contact Info

Drug Safety Research Unit Bursledon Hall, Blundell Lane, Southampton, SO31 1AA, U.K.

Phone: +44 (0)23 80 40 86 00

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