Pharmaceutical Industry opt - outsourcing of pharmacovigilance
03 Jun 2018
Pharmaceutical industry is growing exponentially due to the development of innovative therapies and newer indications along with advancements in drug discovery leading to an extensive increase in the number of products launched into the global market. With this growing potential there is also a substantial increase in the number of adverse events or other safety concerns associated with these medicinal products. Regulatory agencies play a vital role in managing and ensuring the safety profiling of the pharmaceutical/medicinal products and have stringent criteria in granting marketing approvals. For marketing their products in the respective regions (Europe/United States/Rest of World), pharmaceutical companies need to adhere and fulfill the respective regulatory requirements. Regulatory bodies have detailed their specific requirements both at the regional and global levels for effectively monitoring and reporting adverse events, thereby stimulating the need and growth of pharmacovigilance (PV) practices.
“Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems”.
Pharmaceutical companies face many challenges and complexities in complying with the safety data reporting of Individual case safety reports (ICSRs) and other PV activities with respect to the guidelines of the regulatory agencies. All companies marketing the medicinal product(s) should set up their PV department or can outsource to service providers like CROs, KPOs or BPOs.
Setting up in-house PV department has its own set of challenges; where a company needs to have proper organized PV systems, dedicated and experienced PV professionals, quality management system (QMS) in place. In addition to ICSRs, companies need to focus on other core PV responsibilities such as aggregate reporting, signal detection and management, risk management plan (RMP), communication to patient and healthcare professionals for any safety concerns, benefit-risk evaluation of product, qualified person responsible for PV [QPPV] and local PV responsible person (LRP) as applicable, which in turn requires expertise. Ultimately, the time efforts and financial aspects or overhead cost involved for the entire process becomes a real challenge for the companies along with handling the overall medicinal product development and marketing life cycle.
The challenges behind setting up in-house PV system call for pharma companies to outsource their PV activities (either end to end or a part of PV activities) to service providers who perform PV obligations on the company’s behalf maintaining quality and compliance in a timely manner with experienced professionals.
PV service providers have well defined PV systems and procedural documentation in place which adheres to the global PV practices.
There are a multitude of benefits that service providers offer pharma companies:
- End to end PV services – where service provider act as the PV partner to the pharmaceutical company performing all PV activities (majorly includes handling of Pharmacovigilance System Master File [PSMF], Risk Management Plan [RMP])/Risk Evaluation and Mitigation System [REMS], QPPV and LRP services, Literature screening, medical inquiry handling, case processing, case submission, aggregate reporting, signal management]
- Ad-hoc PV services as per client’s need
- QPPV services
- LRP services
- End to end case processing and submission
- Spontaneous – expedited/non expedited case processing only
- Non-spontaneous or periodic cases
- Literature or company case processing only
- Literature screening and management
- Medical inquiry handling and call center
- Aggregate reporting like (PSURs/PBRERs, PADERs, DSURs etc)
- Safety signal management activity
- Handling of legacy data migration
- Set up of gateway for regulatory submissions
- GAP assessment between PV systems
- Auditing the PV system (remote and onsite audit methodology)
- PV training and consultation services
- Ready solutions to cater the needs of medium and small pharma companies to maintain their PV obligations in a cost-effective manner
- Highly skilled/qualified and trained staff dedicated for Pharmacovigilance
- Dedicated team handling the respective PV process
- Manageable resource transitions
- Adaptability and target based resources
- Robust project management and service delivery team for timely deliverables
- Handling the contractual agreements with detailed roles and responsibilities defined
- Clear set of goal’s and deliverables at project kick-off (initiation)
- Milestone set for each PV activities
- Prime contact point with the client bridging the gap
- Systems and guidance’s in place as per global PV requirements
- oWell defined PV system dockets – SOPs/Work Instructions/Guidance’s
- Knowledgeable and experienced regarding global submission requirements
- Dedicated team handling the global submission of ICSRs for various agencies
- Sound with electronic submission through gateways
- Expertise with xEVMPD submission for EU
- Maintain the compliance for reporting ICSRs, Aggregate reporting, RMP and safety variations to the regulatory authorities, safety signal identification and management
- Timely submission of safety data
- Timely updation and submission as per the information available
- Monitors and manages safety signals that might be associated with the medicinal product
- Effective management of safety and risk management activity of medicinal products
- Manage heavy workload of ICSRs by providing ad-hoc case processing services for big pharma companies
- Provides PV safety database licenses, its implementation and validation
PV outsourcing allows pharma companies to select from the pool of outsourced PV activities and pay for the respective ones, instead of setting up the entire PV system in house, its maintenance and skilled resources. By opting for service providers, pharmaceutical companies can primarily focus on their core activities, qualitative expansion of drug discovery – delivery system, targeting newer range of medicinal products along with spreading their global reach.
Lambda Therapeutic Research is a leading multinational CRO, which supports pharmaceutical industries being their outsourcing PV service partner and catering pharmacovigilance needs as per the regulatory requirements. Lambda is providing both; end to end and standalone PV services for more than 400 active moieties for its clients across the globe for more than 8 years. It has a well defined, regulatory accredited, GVP compliant PV systems and procedures in place and has an impeccable track records of 20+ successful regulatory inspections from various regulatory agencies: USFDA, EMEA, MHRA, Polish MOH, Health Canada, AIFA (Italy), FAAG-AFMPS (Belgium), CBG-MEB (the Netherlands), Kazakhstan, etc. Lambda has a team of trained, experienced staff under a strong leadership. It has 21 CFR part 11 USFDA & E2B compliant, cost-effective and user friendly global safety database.
For more details visit our website- https://www.lambda-cro.com/pharmacovigilance/