PV Regulatory Intelligence
Pharma sponsors, MAHs and medical device manufacturers need to establish a comprehensive Pharmacovigilance regulatory intelligence comittee, to implement PV process changes as per the latest regulatory requirements and guidelines, including those related to adverse event reporting, risk management plans, labeling requirements, and clinical trial safety monitoring.
Although it might sound straightforward, establishing a PV regulatory intelligence framework requires pharmacovigilance teams to have thorough knowledge on regulatory requirements, allocation of designated team members with clear responsibilities and a proactive process to keep up with complex safety regulations across geographies for different types of products.
How We Can Help
Our highly experience Pharmacovigilance team can help sponsors with the following objectives to establish a proactive PV Regulatory Intelligence Operations.
As a first step, we enable our client’s PV Team to identify, and understand two main areas of each applicable regulatory body:
> Regional Regulatory Framework – This is the collection of laws, regulations, guidelines, guidance documents and other regulatory instruments through which a government and a regulatory authority control particular aspects of different pharmacovigilance activities. (Eg: US-FDA, EU-EMA, Japan – PMDA, India – DCGI, Australia – TGA, etc.)
> Related Legal Framework – As part of this exercice, we ensure team members understand the actual legislation, statutory requirements, and applicable laws. This involves understanding the structure of each regulatory authority’s mandatory legal obligations, criteria for inspections and assessments, decision making methods, and their requirements for product labels.
Our PV Experts can provide suject matter expertise to:
> Author quality and compliance focused SOPs to conduct pharmacovigilance operations
> Deliver training on applicable pharma regulations for product safety and risk management
> Identify and implement suitable qualitative and quantitative measures to establish pharmacovigilance oversight with quality assurance
> We can provide regular updates to regulatory changes to reporting requirements, labeling requirements, or other safety monitoring guidelines across applicable geographies.
> Communicate the regulatory intelligence to key stakeholders, including pharmacovigilance teams, drug safety officers, and other relevant personnel.
> Provide guidance on implementing new changes and process updates for aligning your PV operations to latest regulations.
