Short Course
Global Pharmacovigilance Regulatory Requirements (Online)
Venue
Online
Date
9 September 2026 - 10 September 2026
Course overview
Our course on ‘Global Pharmacovigilance Regulatory Requirements: New developments and integration into Global Pharmacovigilance Systems’ 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.
Who should attend
- 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 course works
- Taught over two days online
- A combination of lectures and interactive workshops
- Interact with other delegates and speakers via scheduled discussion sessions
- Full access to PDFs and recordings of the presentations afterwards
- Use this course as part of your Continuing Professional Development (CPD)
- Delegates will be sent a Teams link in advance to enable you to join the live course at the stated time
- Certificate of attendance provided upon completion of the course
Our fees
Registration fees include electronic access to all course materials.
Please note, VAT is only applicable for delegates based in the UK.
Cost Per Delegate:
Academic
£775 + VAT
(Academic Units, Public Sector Organisations, Registered Charities)
Standard
£1190 + VAT
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
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
Download programme
Please download the relevant programme for your chosen course date.
9 September 2026 - 10 September 2026
Book now
- 9th September 2026 - 10th September 2026
Limited places available - register early to secure your spot
Our courses are CPD accredited by the Faculty of Pharmaceutical Medicine and are recognised by PharmaTrain.