Pharmacovigilance 

A partner that combines local expertise with a global reach to meet compliance requirements.

Safety doesn’t happen by chance. It happens by vigilance.

A solid extension of your pharma or biotech safety team for both full a PV system and a local safety network across Europe and emerging markets (CIS & EAEU). Our pharmacovigilance team combines modern technology with decades of experience to the highest compliance levels in the industry.

They anticipate your business growth and offer both local expertise as well as up-to-date knowledge of global regulations. The team is fit to handle large Post-Authorization projects and well-suited to tend to small and medium biopharma in clinical development. We often integrate our Pharmacovigilance services with our Medical Information and Regulatory Affairs services, working efficiently as a multi-disciplinary team.

Pharmacovigilance
QPPV Case Processing Safety Database Aggregate Reporting RMP Writing PV System Set-Up PSMF Creation Spontaneous Reports Literature Screening Regulatory Intelligence

QPPV

Many pharmaceutical firms with a non-EU basis, no in-house PV skills, or business choices to concentrate on key strategic competencies seek to externalize these vital tasks. Therefore, outsourcing QPPV in the EU/EEA has several benefits. Biomapas' QPPV solutions include these professionals in the EU and CIS/EAEU Region to manage and maximise PV outcomes effectively.

Case Processing

An effective pharmacovigilance (PV) program must ensure patient safety at all times. Defined as the identification, collection, and processing of Individual Case Safety Reports (ICSRs), all pharmaceutical and biotechnology firms are required to submit to regulatory authorities following stringent criteria and deadlines. With the help of our PV experts, we can guarantee that you meet your case processing needs.

Safety Database

Biomapas Pharmacovigilance specialists utilize Vault Safety powerful tool for collecting, managing, and providing real-time oversight of adverse events for more informed decisions and improved compliance. In addition, it features streamlined adverse event management with role-based assignment and routing of safety cases for follow-up and medical review.

Aggregate Reporting

Our staff at Biomapas works vigorously to guarantee accurate and compliant aggregate safety reports. As pharmacovigilance and aggregate safety report writers, we have a wealth of experience from pharma and biotech, authorities, and academics. We also provide you with guidance on aggregate safety data analysis and benefit-risk evaluations to ensure patient safety and well-being.

RMP Writing

The Risk Management Plan (RMP) addresses and summarizes a product's safety and efficacy concerns throughout its lifecycle.  Biomapas' clinical and quality professionals support you in developing and maintaining a high-quality, compliant RMP.

PV System Set-Up

Post-market monitoring is required in the EU/EEA, the US, and other large pharmaceutical markets (MAA). A comprehensive pharmacovigilance system includes a safety database, SOPs, and a network of trained, certified people working with local authorities in local languages. Thus, a PV system needs significant expenditure, which is not always desirable or practical for smaller pharma. Working together with Biomapas' experts allows you to outsource the complete set-up or individual parts efficiently. 

PSMF Creation

A thorough PSMF offers a critical first look into your company's PV system for EU regulatory inspectors. The Pharmacovigilance System Master File is a business-critical document that summarizes the Marketing Authorization Holder's (MAH) PV system. We develop and maintain a PSMF that correctly and completely defines your company's PV system. 

Spontaneous Reports

Spontaneous reporting is an important aspect to pharmacovigilance (PV), relying on the motivation of individuals to report suspected adverse drug reactions (ADRs) to a local or national pharmacovigilance centre. Biomapas' spontaneous reporting system handles Individual Case Study Reports (ICSRs)  helping you detect and confirm safety signals.

Literature Screening

To maintain compliance with regulatory laws throughout the globe, global and local literature screening is essential to discover reportable Individual Case Safety Reports (ICSRs) and detect new safety signals for developing safety concerns. To guarantee that your pharmacovigilance (PV) program complies with worldwide regulatory standards, our expert team at Biomapas can assist you with all of these tasks.

Regulatory Intelligence

The Regulatory Intelligence services provided by Biomapas may help you establish a sustainable drug development program, perform efficient clinical trials, and develop a solid commercialization strategy. A good plan will save you time and money by combining our expertise with publicly available data and data based on our own experience. We help you make strategic choices and get an advantage in a competitive market.

Clinical Trials

 

Biomapas team experts are able to provide clinical safety service in a wide range of therapeutic areas and product classes, starting from clinical safety set-up, going to continuous surveillance of the study and finalizing with study closure activities. Our experienced team offers fast and reliable safety management plan development and smooth execution. We ensure efficient safety database set-up, including individual tenant environment set-up, specific case attributes and data migration. Clinical Safety

Medical Monitoring

 

 

 

PV System & QPPV

Biomapas supports Marketing Authorisation Holders and Applicants in the fulfillment of all pharmacovigilance obligations regarding medicinal products, including the establishment and maintenance of Pharmacovigilance System, and offers experienced EU Qualified Person for Pharmacovigilance to take responisiblity of your pharmacovigilance affairs.

 

 

 

 

 

 

Pharmacovigilance System set-up & QPPV

PSMF Development & Maintenance

RMP Development & Maintenance

EAEU-QPPV

National QPPV

Pharmacovigilance Database

Pharmacovigilance Auditing

Post-Authorization

We offer all necessary global, comprehensive drug safety services to complete or entirely outsource your pharmacovigilance activities. Our expert team members, who hold degrees in medicine and pharmacy, maintain consistent case processing according to all EMA requirements while recording cases in Safety Database with supreme at least four-eye quality check and assessment.

 

Local Pharmacovigilance Operations

Global and Local Literature Screening

 

 

 

Geographical Coverage

Veeva Safety Database

Clinical Trials

Biomapas team experts are able to provide clinical safety service in a wide range of therapeutic areas and product classes, starting from clinical safety set-up, going to continuous surveillance of the study and finalizing with study closure activities. Our experienced team offers fast and reliable safety management plan development and smooth execution. We ensure efficient safety database set-up, including individual tenant environment set-up, specific case attributes and data migration.

Clinical Safety

Medical Monitoring

PV System & QPPV

Biomapas supports Marketing Authorisation Holders and Applicants in the fulfillment of all pharmacovigilance obligations regarding medicinal products, including the establishment and maintenance of Pharmacovigilance System, and offers experienced EU Qualified Person for Pharmacovigilance to take responisiblity of your pharmacovigilance affairs.

Pharmacovigilance System set-up & QPPV

PSMF Development & Maintenance

RMP Development & Maintenance

EAEU-QPPV

National QPPV

Pharmacovigilance Database

Pharmacovigilance Auditing

Post-Authorization

We offer all necessary global, comprehensive drug safety services to complete or entirely outsource your pharmacovigilance activities. Our expert team members, who hold degrees in medicine and pharmacy, maintain consistent case processing according to all EMA requirements while recording cases in Safety Database with supreme at least four-eye quality check and assessment.

Local Pharmacovigilance Operations

Global and Local Literature Screening

Geographical Coverage

Veeva Safety Database

PV Professionals

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Medical Doctors

Countries covered

QPPV & LPPV Network

Inhouse experienced EU QPPVs and a network throughout Europe to comply with local requirements.

In-house Workforce

Not another middleman, working through own workforce across Europe and CIS

Integrated Solutions

We combine our Medical Information expertise with RA & PV in multi-disciplinary teams.

Blog

Setting Up A PV System

Setting up a pharmacovigilance system requires a great deal of expertise in risk management planning, data collection, analysis, and writing/reporting standards. Our experts wrote this article on setting up your pharmacovigilance system to help you on your way.

A Global Player That Understands Local Nuances In Hard-To-Reach Regions 

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Martijn van de Leur

Martijn van de Leur

Head of Global Pharmacovigilance

Martijn van de Leur has over 15 years of experience in pharmacovigilance. Throughout his career in big pharma, Martijn went from entry-level positions in safety data management to senior medical advisory roles within the Clinical Risk Management teams. He also helped his companies to develop their PV systems through multiple massive company merger integration projects. Before joining Biomapas, Martijn held several executive roles as (Deputy) EU QPPV, Global Head of PV Compliance and Global Head of PV Technologies.