Global Pharmacovigilance Regulatory Requirements – What’s New? (Online)

Course Overview

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, Australia and New Zealand, the Middle East, Africa and Asia including inspection and legal implications.

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.

Please note, 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

How our courses work

• Taught over two days
• A combination of lectures and interactive workshops in smaller groups
• Network with other delegates and speakers via scheduled discussion sessions (virtual delegates), and during coffee and lunch breaks (in-person delegates)
• Full access to PDFs of the presentations afterwards
• Use this course as part of your Continuing Professional Development (CPD)
• Refreshments and lunch provided (in-person delegates)
• Virtual delegates will be sent a link in advance to enable you to join the live course at the stated time

Aims of the 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

Our fees

Please note, VAT is only applicable for delegates based in the UK.

Cost Per Delegate:

• Academic

  £620 + VAT

  (Academic Units, Public Sector Organisations, Registered Charities) - Virtual

• Standard

  £952 + VAT

  Virtual

Registration fees include electronic access to all course materials.

Book now

• 14 June 2023 - 15 June 2023

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  UK Based International

  Download course programme