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PATIENT SUPPORT PROGRAMS

3B Biotech proposes itself as a partner in the analysis of the needs and design of PSP with an adequate cost- effectiveness ratio.

We ensure full compliance with Pharmacovigilance associated with PSPs in accordance with the current legislation.

In a constantly evolving healthcare environment and with patients able to always have more information about their diseases and therapeutic pathways, the Patient Support Programs (PSP) have acquired a fundamental importance in managing the diagnostic/therapeutic path in the best way, managing the differences between the various patients and their expectations.

Designing and conducting PSPs becomes essential to support the patient to correctly follow a therapy, reduce the movement of the same from his home, to use health resources more correctly.

3B Biotech proposes itself as a partner in the analysis of the needs and design of PSP with an adequate cost / effectiveness ratio.

3B Biotech is also able to ensure compliance with Pharmacovigilance associated with PSPs in accordance with the local and European legislation.

Good Vigilance Practices (GVP)-Module VI addresses legal requirements applicable to stakeholders regarding the collection, data management and reporting of suspected adverse reactions associated with medicinal products for human use authorised in the European Union (EU). This module also contains requirements applicable to Marketing Authorisation Holders (MAHs) for the management and reporting of safety data arising in PSPs.

Serious, non-serious cases of suspected adverse reactions originating in those programmes should be reported by MAHs as solicited reports

PSP includes services that involve direct interaction with patients and/or patient carers for the purpose of

  • Helping to manage a patient’s medication and/or disease outcomes (e.g., adherence, awareness, education), or
  • Providing or arranging financial assistance for patients who cannot afford their medication. (e.g. reimbursement support, product discount), or
  • Providing healthcare professionals with support for their patients

In the frame of those programmes the safety  information relating to the use of its medicinal products are collected.

Patients/carers may reports events which occurred concomitantly to the use of medicinal product and which could be suspected adverse reactions.

Where information from PSPs is helpful:

  • Can provide good insights into what is important to patients in relation to their disease or treatment
  • Generating information on what may impact ability of patients to comply with treatment ( i.e. optimise benefit)
  • Can help direct where advice and support are needed with respect to seeking medical help or where reassurance is needed to avoid discontinuing treatment inappropriately
  • Confirms what is already known

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