PVpharm

Hybrid face-to-face and remote training course in Madrid focused on pharmacovigilance, QPPV responsibilities, EMA updates, signal management, and artificial intelligence in drug safety.

Face-to-face professional training course in Madrid focused on pharmacovigilance updates, audits, inspections, QPPV role, Eudravigilance, signal detection, and GDPR.

GxP support and quality system setup including GMP specialized audits.

Quality management services and standard operating procedure (SOP) development for pharmacovigilance systems.

PVpharm supports organisations in building and maintaining robust quality systems aligned with international GxP standards, helping strengthen operational reliability.

Support services for Marketing Authorisation Holders to comply with the mandatory use of EudraVigilance Data Analysis System (EVDAS) for signal detection under Commission Implementing Regulation (EU) 2025/1466.

Specialized CTIS Portal Management services to support sponsors with clinical trial submissions and lifecycle management under EU CTR 536/2014.

Systematic screening of medical and scientific literature for safety data and adverse event reports.

Comprehensive Medical Literature Monitoring services to identify relevant safety information at both global and local levels, in line with GVP Module VI.

Virtual live training courses covering essential concepts and guidance about the Pharmacovigilance System Master File (PSMF) and the PSMF from a global context.

A virtual training course organized by DIA covering Pharmacovigilance and Quality Management Systems, delivered online from September 22 to 25, 2025.

Service assisting pharmaceutical companies with Organization Management Service (OMS) registration to comply with AEMPS requirements.

Support and troubleshooting services to resolve issues encountered during the OMS registration process.

Independent and comprehensive audit services offered by PVpharm to assess the quality and compliance of pharmacovigilance and clinical safety systems.

PVpharm provides EU Qualified Person for Pharmacovigilance (EU QPPV) and Deputy EU QPPV services with extensive knowledge and experience of the industry, including local contact persons for pharmacovigilance in several EU countries.

Pharmacovigilance and GCP audit services to ensure compliance and quality assurance.

Expert pharmacovigilance support to ensure timely and compliant submissions for Marketing Authorisation Applications, including MAA dossiers support, benefit-risk assessments management, RMP management, and Regulatory Authorities requests.

Individual Case Safety Report (ICSR) management and medical review services ensuring robust safety operations.

Specialised scientific and clinical expertise to support pharmacovigilance, clinical safety, and regulatory activities including medical information management and literature evaluation.

Flexible Safety Database Management services tailored to your needs from setup and configuration of validated safety databases to ongoing maintenance and regulatory submissions.

Comprehensive PSMF services provided by PVpharm, including creation, ongoing maintenance, audit-readiness support for regulatory inspections, and EU-based PSMF solutions for non-EU companies.

PVpharm provides reliable Legal Representation and Responsible Person services for pharmacovigilance purposes, ensuring compliance with EU legislation and maintaining effective communication with Regulatory Authorities.

Clinical safety services covering the collection, medical review, and regulatory reporting of Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) during clinical development.

Tailored Clinical Safety Training programs designed to strengthen your team’s knowledge of pharmacovigilance, adverse event reporting, and risk management in clinical development.

Expert services for the preparation, review, and maintenance of Safety Management Plans (SMPs) and Investigator Brochures (IBs) ensuring alignment with regulatory expectations and best practices.

Regulatory affairs support and consulting services for the pharmaceutical industry.

Support and training for sponsor staff on EudraVigilance processes, including profile management and safety report handling.

Provision of EU-QPPV and local contact persons for pharmacovigilance operations.

Expert safety input and protocol review services to optimize clinical trial design, anticipate potential risks, define safety monitoring measures, and protect participant safety.

Expert medical monitoring and evaluation services to support sponsors and CROs in ensuring subject safety and data integrity during clinical trials.

Safety Data Exchange Agreement (SDEA) management and expert regulatory consultancy services.

Design and execution of Post-Authorization Safety Studies (PASS) for medicinal products.

An introductory training course on pharmacovigilance offered by PVpharm.

Expert support in the preparation, review, and submission of Development Safety Update Reports (DSURs) to ensure ongoing safety monitoring and regulatory compliance during clinical development.

Preparation of Periodic Safety Update Reports (PSUR), Risk Management Plans (RMP), and other regulatory safety reports.

Includes safety summaries for regulatory queries, and safety sections for renewals or variations.

Integration of sponsor profile data with clinical trial safety reporting workflows to ensure timely and accurate ICSR submissions.

Registration and validation of sponsor profiles in the EudraVigilance Clinical Trial Module (EVCTM), ensuring compliance with EMA requirements.

Preparation, writing, and submission of Periodic Safety Update Reports (PSUR) and Development Safety Update Reports (DSUR).

Keeping track of EMA updates and ensuring sponsor profiles remain compliant with evolving regulations.

Risk Management Plan (RMP) writing and Pharmacovigilance System Master File (PSMF) management and creation.

Compilation of cumulative safety data, analysis of benefit-risk balance, and regulatory submissions in accordance with ICH E2C(R2).

Creation and updates of RMPs following GVP Module V, including safety specifications, pharmacovigilance plans, and risk minimization measures.

Expert support services to ensure compliance with XEVMPD (Article 57) and upcoming IDMP requirements, maintaining accurate product data and inspection readiness.

Prepared for EU marketing authorization applications when required.

Ongoing updates and verification of sponsor information to reflect organizational changes or new clinical trial portfolios.