>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)
- Or £775 + VAT academic
Book your place
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.
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.
The course is recognised by PharmaTrain.
“Very good course. Excellent content and speakers” Global Regulatory Pharmacovigilance Environment Delegate 2017
“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
– 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
– 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
Our next course
Monitoring Safety in Clinical Trials and Drug Development
The implementation of the Clinical Trials Directive was a critical event for clinical research and pharmacovigilance, which impacted on all those working in this area. Its standards have influenced regulatory expectations, together with new ICH standards such as the Development Safety Update Report and pharmacovigilance planning, bringing new challenges to safety personnel.