Focus on your customer and ensure their needs, preferences, and…
Defining roles and responsibilities for the pharma company and the vendor
Which PV processes are necessary to outsource, and which are not?
Various processes within PV can be outsourced; however, I would not agree that some processes are necessary to outsource, but the decision to outsource and which processes to outsource should be taken following a careful consideration of associated risks and benefits. Typically, PV processes that are being outsourced are e.g. case processing, medical review, and regulatory reporting, while other processes like signal detection and risk management may be kept in-house. Ultimately there is no general answer, as the decision to outsource PV processes depends on various factors, like company’s size, resources, expertise, and risk tolerance.
How to select the right partners, and where are the limits of the vendor’s role?
Selecting the right partners for outsourcing pharmacovigilance processes is critical to ensure quality, compliance, and effectiveness of PV activities. Some of the key points to be considered to ensure the right partners are being selected:
- Experience – Make sure the vendor is having the experience and expertise in the area that is being outsourced
- Quality: Make sure the vendor has an appropriate quality system and processes in place
- Compliance: Ensure the vendor is compliant with relevant regulatory requirements and agreements
The limits of the vendor’s role will depend on the specific processes being outsourced, but in general, vendors should not make any final decisions that could impact the safety or efficacy of the product. Clear roles and responsibilities for both the company and the vendor should be in place. The outsourcing company is ultimately still responsible and therefore needs to maintain oversight of all PV activities, including monitoring and managing the vendor’s performance, conducting quality control checks, and ensuring that all regulatory requirements are met.
What is, in your opinion, the key factor in a patient-centric approach to pharmacovigilance?
In my opinion, one of the key factors in a patient-centric approach to pharmacovigilance is the active involvement of patients and their caregivers in the reporting of adverse events and the assessment of a products’ benefit-risk balance. This can be achieved through various initiatives, such as patient support programs, patient-centred outcome research, patient-focused drug development, and patient engagement in regulatory decision-making.
Applying a patient-centric approach to pharmacovigilance supports building trust and confidence between patients, healthcare providers, and the pharmaceutical industry. Valuable insights into patients’ experiences with the products and better understanding of the potential impact of adverse events on patients’ health and quality life can be gained by applying this approach.
Additionally, by prioritizing patient safety and incorporating patient perspectives into the development and monitoring of medicines, companies can demonstrate their commitment to serving the needs of patients and contributing to better health outcomes.
Claudia Nolte is Senior Director, Global Pharmacovigilance & Regulatory Quality Assurance (PVRQA) within Global Quality at CSL Behring, located in Marburg, Germany. In the current role she is responsible for CSLs’ global PV Audit Program, as well as for other aspects of the PV Quality Management System including 3rd Party Quality Management and Oversight, Deviation and CAPA Management, Inspection Preparation and Management, and Continuous Improvement.
Claudia holds a Master of Science in Pharmaceutical Medicine from the University of Surrey, Guildford, UK and has been in the pharmaceutical industry for more than 30 years; more than 15 years thereof in various positions within Quality Assurance. Since the implementation of GVP in Europe, she has been responsible for the development and maintenance of a proper PV Quality Management System for CSL’s Global PV System.