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Pharmacovigilance: in-house or outsourced? Challenges and opportunities for pharmaceutical companies in the era post-Directive 2010/84.

After Directive 2010/84 has become effective, pharmacovigilance landscape has deeply changed.

Pharmaceutical companies find themselves to face a complex and challenging subject, with regulatory obligations  increasingly stricter  along with the need to ensure drugs’ safety and efficacy for patients.

In this context, pharmacovigilance outsourcing can be a strategic resource to relieve in-house workload and access specialist expertise.

Pharmacovigilance: when is outsourcing convenient?

Pharmaceutical companies can decide to outsource some pharmacovigilance activities for different reasons:

  • Lack of internal resources: specialist expertise,  dedicated staff, suitable infrastructures.
  • Small-sized company: difficulties in managing  pharmacovigilance complexity in-house.
  • Need of flexibility: work peaks, launch of new products, temporary needs.
  • Focus on core activities: concentrating in-house resources on their own area of strategic expertise.

Choosing the right partner: key requirements

Outsourcing pharmacovigilance to a third partner requires careful evaluation:

  • Experience and expertise: documented experience in the sector, knowledge of regulations and best practices.
  • Service quality: high standard standards of accuracy, reliability and promptness.
  • Dedicated resources: a team of qualified professionals subject to continuous training
  • Technology: advanced  information systems for  data managing  and communication.
  • Exchange and cooperation: proactive and transparent approach in the collaboration.

Outsourced pharmacovigilance: investing in patients’ safety

The decision to outsource pharmacovigilance can result in a winning move for pharmaceutical companies, allowing them to:

  • Optimize their resources:  reducing fixed costs  and increasing flexibility.
  • Improve service quality: accessing specialist’s expertise and advanced technologies.
  • Comply with regulatory obligations: reducing the risk of non-conformities.
  • Increase their focusing on patients: dedicating more resources to the development of safe and effective drugs.

Ultimately,  outsourced pharmacovigilance represents a valid tool for pharmaceutical companies to ensure the patients’ safety and meet the requests of a market in constant evolution.

Here is an example of some activities that can be outsourced, even individually, to external pharmacovigilance providers:

  • Assumption of the role of QPPV and Local Contact Point
  • Control and medical evaluation of Italian and international literature
  • Support in the preparation of PSURs and RMPs
  • Support in the preparation of PSMFs
  • Download of ICSRs from Eudravigilance  and relevant medical evaluation
  • Periodic evaluation of safety data for signal identification
  • Drafting of standard operating procedures (SOPs) and work instructions
  • Preparation or revision of safety agreements (Safety Data Exchange Agreement, SDEA) with Partners

Every company shall choose based on their own needs and organization. Scritto il 21/05/2024 da: Sara Moretti e Costantino Forleo

Written on 21/05/2024 by: Sara Moretti and Costantino Forleo