Pharmacovigilance

Metis Consultants have extensive years of experience, and many of our group have over two decades of experience in Pharmacovigilance.

We offer a full range of GVP (Good Pharmacovigilance Practice) guidance. We are committed to providing comprehensive, customized GVP services tailored to your company’s needs. Our consultants are experienced and knowledgeable in all aspects of pharmacovigilance requirements and nuances of worldwide local requirements. We help our clients focus on proactive approaches and solutions, ensuring that organizations meet the highest levels of compliance. We provide PV services to Marketing Authorisation Holders, Sponsor organizations, CROs, and SMOs at all levels.

Effective compliance is inherently challenging to measure since the absence of regulatory scrutiny and violations is the primary indicator of success. Issues may be overlooked until disaster strikes. Proactively investing in a strategic framework can prevent regulatory trouble, financial penalties, and negative publicity. Establishing a value-based monitoring program can change the perspective of the compliance program. 

We can help your organization create an infrastructure that encourages individuals to account for moral considerations when facing ethical ambiguities. We help equip decision-makers with tools rather than just rules. Compliance Monitoring programs enhance transparency, which has value beyond regulatory concerns: improving outcomes for business partnerships, succession, and knowledge sharing across organizational departments. Monitoring provides an unparalleled view across the scope of the company’s operations and offers many valuable advantages. Through regular and frequent monitoring, companies can identify areas of substantive risks and undertake mitigation strategies before any red flags manifest as regulatory violations. These “spot checks” or “soft audits” provide a superior level of protection to organizations before formal audits and inspections occur. While auditing is necessary, it is by its nature reactive. Monitoring is proactive — and in the long run, proactivity provides better protection against errors, violations, and financial losses. 

Metis’s Consultants will help create good communications for operations across departments and divisions domestically and globally. 

We help create a strategy for real-time risk management, analyzing the why’s and how-tos. This results in better interactions with consumers and the public. You protect the organization’s reputation and maintain public trust.

We aid in defining and benchmarking best practices and improving communication with the board and investors. As a third-party company brought on board to help facilitate strategic compliance strategy, we are ideally positioned to act as agents of change. Metis enables you to build operational resilience.  

A Pharmacovigilance System Master File (PSMF) is the document that summarizes the pharmacovigilance (PV) system. The PSMF is a critical document for any Marketing Authorization Holder (MAH.) Since July 2012, MAHs in the EU are responsible for submitting and maintaining information on all EU-approved medicinal products and clinical trials. To comply with EU PV legislation requirements, all MAHs and MAH applicants in the EU must develop and maintain a PSMF for their PV system. Beyond the EU, conditions for other local/regional PSMFs arise.
Metis’ experienced Consultants assist you in building and managing a PSMF that accurately and comprehensively describes your company’s PV system. They also help reduce the maintenance burden, especially when more PSMFs than the “basic” EU version are required.

Your PMSF is most important during the authorization phase as evidence of having an adequate PV system. It is a prerequisite for Marketing Authorization Approval.
Post-authorization, the PMSF is usually the starting point for regulators during inspections as it provides essential insights into your compliance regarding pharmacovigilance requirements. Metis’ consultants understand PSMF complexity and the nuances of applicable guidelines. We specialize in Good Pharmacovigilance Practice (GVP) and all the other relevant local/regional legislation, which is vital when your organization develops its PSMF.

Our PV experts can help ensure consistency throughout your clinical trials.

Metis’ consultants guide you through every step of the PV process and pivot to meet your developing needs. We operate globally and can support our clients throughout the complete product lifecycle. We are also in a great position to help you with Process Improvement and assistance with preparing Corrective Action and Preventive Action (CAPA) plans.

The requirement for a REMS program can generate various questions: How do REMS programs work? What are the implications? What responsibilities do sponsor organizations have when the FDA has assigned them a REMS? We can assist with developing solutions to answer those questions. As such, Metis has partnered with RIC (REMS Industry Consortium), which includes the foremost experts in the field.

Patient Support Programs (PSPs) is an umbrella term to describe initiatives led by pharmaceutical companies to improve access, usage, and adherence to prescription drugs. These programs can have a financial component, support clinical investments, focus purely on education, or a combination.

 The European Medicines Agency has set up patient registries as organized systems that collect standardized data on a specific population. Each of these populations is defined by a particular disease or condition. The EMA follows patient registry data over time. Patient registries can play an essential role in monitoring the safety of medications. The EMA has established an initiative to use existing registries better. And to facilitate the creation of high-quality new registries when a good source of post-authorization data is needed for regulatory decision-making.

Metis’ Consultants can help your organization navigate these registries and requirements throughout the EU.