An ATU (temporary authorisation for use) is the French version of compassionate use and is granted by the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) in France subject to the following conditions:
– Specials are to be used for treating, preventing or diagnosing serious or rare diseases
– No other appropriate treatment is available
– There is sufficient scientific evidence to show their efficacy and safety
In practice, there are two kinds of ATU: cohort ATUs and named patient ATUs.

In France, the ANSM grants an RTU (temporary recommendation for use) to cover off-label prescriptions that do not comply with the marketing approval obtained, as long as:
– There is a therapeutic need
– The risk/benefit ratio is considered as favourable, in particlular in reference to published scientific data concerning efficacy and tolerance
The aim is to ensure that medicinal products are used safely through patient follow-up organised by the laboratories concerned.

We have created a team specialised in handling and following up ATUs and RTUs and ready to share its experience with you and provide advice on your projects.

Protocol for Therapeutic Use (PTU)

– Assistance with writing the protocol whether for a named-patient or cohort ATU or an RTU
Critical revision, especially for appendices covering data collection
Finalising of layout and distribution to physicians, pharmacists, French Regional Pharmacovigilance Centres (CRPV) and French Poison Centres (CAP)

ATU/RTU unit

Creation of a dedicated team with back-ups
– Assigning a dedicated freephone no./fax no./e-mail account
Management, revision, compliance-checking and validation of data

Web portal/data collection

Installing of a modular application dedicated to collecting data:

Account creation module

Data collection module

– Documentation module

Reporting module

For ATUs, data can be collected via a paper or electronic CRF or a combination of both.

ATU and RTU specifics

ATU specifics:
Medical validation of access to treatment requests
Management of treatment ordering logistics

RTU specifics:
Management of data flows
– Creation of automatic alerts

Pharmacovigilance and periodic report

– Management of pharmacovigilance cases together with the sponsor
Write-up of oral statements
Management of queries together with the sponsor’s pharmacovigilance unit
Creation of e-mail alerts
Quality control
 Production of French and English versions of summary reports and synopses

EURAXI

Euraxi is a project management specialist in clinical research and epidemiology, assisting clients with their projects since 1986. Our organisation and service offer have been perfectly tailored to meet the precise needs of our clients. We can take on all or part of your operations thanks to our multidisciplinary team. This team is organised into specialised units and is guided by quality procedures inherent to the requirements of your projects.

CONTACT

10 Rue Gutenberg
37300 Joué-lès-Tours
France

Tel: +33 2 47 74 32 00

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