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Pharmacovigilance Services

Improve your internal processes and ensure compliance with pharmacovigilance regulations.

EXTEDO understands the compexities of integrating competent business processes with contemporary technical solutions such as an easy-to-use safety database which enables the timely capturing, assessment and reporting of cases.

With the introduction of the so-called “Pharmapackage” within the EU in 2012, a large amount of new pharmacovigilance requirements had been introduced. The aftermath of which is still ongoing as the updates affected not only the processes themselves, but also impacted other groups such as Regulatory Affairs, Quality Assurance and Clinical Research. The complexity has been accentuated by the Brexit and separate requirements imposed thereof. These processes compose a heavily regulated, yet countinously changing drug safety environment. Today, the challenges to maintain conformance to these requirements, to tie them with electronic safety solutions, and hence to accurately reflect the entire pharmacovigilance infrastructure and activities in the PSMF, are greater than before.

Tailored consulting services for pharmacovigilance

EXTEDO’s Pharmacovigilance Business Process consulting services are tailored specifically to your needs. Based on many years of experience working hands-on with drug safety rules and regulations, EXTEDO´s team will support you in all aspects of your pharmacovigilance activities.

Advice on processes / resources

Based on your needs and the results of our gap analysis, EXTEDO will provide individual best practice consultancy. Working together with your experts, EXTEDO will identify optimization opportunities for your pharmacovigilance processes and resources. In addition, we will provide advice on concrete improvement possibilities and how to implement them.

Benefits

Optimize processes and interfaces to ensure a proper and timely handling of mandatory activities

Ensure compliance through a full understanding of current and upcoming pharmacovigilance requirements

Ensure your procedures are up to date, optimized and compliantly reflected in your PSMF

Technical and operation support to meet your pharmacovigilance workload

Support for the implementation and optimization of existing processes

With pharmacovigilance systems being complex and consisting of many different processes and tasks each organization will have their own priorities as to which changes need to be made first. We provide you with the guidance you need to make these critical decisions, and to implement your chosen solution.

Gap-analysis of your pharmacovigilance processes

A pharmacovigilance system is a complex network of processes with numerous tasks and responsibilities. Changes in legal requirements or internal structures necessitate rework and adaption of these processes. Similarly, updates to technical infrastructure, e.g. a new safety database, may also trigger process changes. EXTEDO will analyze your pharmacovigilance processes and will highlight any gaps. We will align with your business operating model to identify improvement opportunities and help you implement appropriate strategies to perform them.

Technical and operational support for your pharmacovigilance workload

EXTEDO’s team can support you with your daily pharmacovigilance tasks and activities by providing you with additional qualified technical assets to address your routine pharmacovigilance operations or to cope with an emerging one-off project of yours that brough an unanticipated increase in your workload. Our team has hands-on experience and many years of expertise in drug safety and can reliably assist you in meeting your regulatory compliance targets even with high project payloads and complexities.

Resources

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