Pharmablue / Our Early Access Services

Our EAP Services

Our services in relation to EAP in France (Early and Compassionate Access)

PharmaBlue can provide integrated solutions and assist pharmaceutical companies looking to fastly obtain Early Access Authorizations and launch EAP in France for their pharmaceutical products, in particular through the following services:

  • Prepare  shaped pre- and post-MA Early Access Authorization applications and provide full-range of experts support until approval
  • Set-up relevant activities to allow fast launch of EAP, and ensure patients’ treatment and follow-up in compliance with local requirements
  • Act as “Exploitant” and ensure liability for all related activities at the time of EAP and throughout the product life cycle, once price and reimbursement are granted

From EAP preparation until granted by French Healthcare Authorities

PharmaBlue provides full range of experts advice and support through:

  • Management of discussions with ANSM and preparation of relevant documentation until Compassionate Access is granted
  • Preparation and organization of pre-submission meetings with HAS for pre-MA early access authorization
  • Filing of Early Access Authorization applications until approval by HAS +/- ANSM in order to respond to authorization criteria

Provided services include but are not limited to:

  • Prepare the Early Access Authorization application according to defined authorization criteria and including set-up of all documentation including protocol for therapeutic use (PUT), specific product information (SmPC, leaflet & label)
  • Communication with ANSM, response to questions and set-up of a PUT-SP related to Compassionate Access
  • Provide ad-hoc advice or respond to specific questions, including strategy and/or positioning of the  program

French Early Access Program management for a US pharmaceutical company

Case study

An American pharmaceutical company starting to build its European affiliates entrusted PharmaBlue with the responsibility of submitting, obtaining, and implementing…


Read the case
Plan de travail 97 copie 5@2x

Before launching the EAP

Before launching an EAP in France, PharmaBlue sets up a dedicated core-team (EAP cell) and tools for the management of the EAP.

Provided services include but are not limited to:

  • Project management providing visibility at each stage
  • Set-up a dedicated core-team (EAP cell) and tools for the management of the EAP
  • Set-up of technical agreements between the EAP Holder, PharmaBlue, the manufacturers as well as the distributor (or any other third parties) involved to clarify roles and responsibilities (including SDEA for pharmacovigilance)
  • Review and approval of product information and artworks
  • Set-up a database for the management of the EAP
  • Set-up the distribution channel

Preparation of communications to HCPs involved in the EAP, Q&A, etc.

Plan de travail 97 copie 10@2x

Exploitant Services during EAP launch

The Exploitant services provided by PharmaBlue include the organization and supervision of the pharmaceutical operations in France as described in art R 5124-36 of the Public Health Code and more particularly, in the context of a cohort ATU:

  • Support the EAP Holder for the communication with authorities (ANSM, HAS, CEPS)
  • Check compliance of products operated on the French market with French regulations & EAP, including batch follow-up. Respond to pharmacists about their orders and follow-up with distributor/transporters
  • Local contact person for PV (Art.R5121-164) and management of local Pharmacovigilance (PV) in line with the French regulations, i.e. receiving, archiving and following up adverse drug reactions received in France as required by local regulations, guidelines, and applicable SOPs, and submitting ADR forms to ATU holder and its EU organization for PV
  • Handle local product complaints and batch recalls, i.e. ensuring management of product complaints and recall of products distributed in France in line with French regulation
  • Review and approve artworks and printed packaging components
  • In close collaboration with the manufacturer, the distributor of the product in France and EAP holder, ensure products are distributed according to conditions ensuring appropriate storage, transportation, security and integrity, ensure appropriate treatment of issue likely to have an impact on public health (Art.R5124-55), ensure compliance of the product distribution with the GDP and regulation requirements within the French territories, monitoring of batches on the French market. Conduct audits of the different stakeholders
  • Handle medical information requests with On-call support service 24/7 and reply to healthcare professional and patient questions

Management of the EAP

Once the EAP launched, PharmaBlue wil also handle the following activities:

 

  • Data management, close patients’follow-up according to approved protocol for use
  • Management of Pharmacovigilance activities, Medical Information Enquiries, Quality/logistical complaints
  • Manage all communications with hospitals and HCPs involved in EAP
  • Handling of pharmacist orders
  • Preparation of periodic reports and summaries
  • Set-up of compensation agreements for data collection with hospitals and calculation of compensation balance
  • Regulatory intelligence