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
