Global Pharmacovigilance Regulatory Requirements – What’s New?
Venue: Novotel London West Hotel, Hammersmith, London
Date: 28 Oct – 29 Oct 2020*
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.
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 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
How our courses work
- Taught over two days
- Small class size allows for one-to-one interaction with expert tutors
- A combination of short lectures, practical workshops and interactive discussion sessions
- Taught by a panel of expert speakers (minimum of four speakers per course) from industry, regulatory authorities and academia
- Course materials including presentations, workshop material and suggested reading documents are made available electronically during the course
- The agenda provides ample opportunity to network with expert speakers and your fellow delegates
Lunch, refreshments and all course materials are included in the registration fee.
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
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
- 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
Cost Per Delegate:
£775 + VAT Academic
(Academic Units, Public Sector Organisations, Registered Charities)
£1190 + VAT Standard
Registration fee includes lunch, refreshments and electronic access to all course materials.
Download Course Programme
Click here to download the programme
“New information has been added to my knowledge – thank you.”
“Well planned course with very interesting topics and excellent presenters”
“Speakers had excellent knowledge in their fields, good discussions and interactions between the participants, well prepared material and supportive overviews”
“The course was very informative and well thought through. I enjoyed all the speakers and their enthusiasm for their topics “
“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.”