Would You Like to Join Our
Pharmacovigilance Trainings?

Objective

A good pharmacovigilance system begins with a knowledgeable team.

This training ensures that your employees not only learn the adverse reaction reporting process but also realize why it is important.

🎯 Our Goal:
To create a structure that can report adverse reactions more effectively, accurately, and on time;

increasing pharmacovigilance awareness across your entire team.

• Content aimed at employees at all levels
• Practical instruction through real cases
• Presentations shaped with examples specific to your institution

We are here to embed a pharmacovigilance culture into your organization.

About Training Content

🎓 Our trainings are prepared in full compliance with current regulations and standards, taking into account TITCK interpretations and approvals.

🎥 Our presentations are supported by visuals, videos, and case studies, aiming for participants to truly grasp the subject rather than just hearing it.

💬 The foundations of pharmacovigilance are conveyed solidly with content that is clear, practice-oriented, and free from technical jargon.

Meet training content that is memorable, audit-ready, and far from boring slides.

Training Levels

Not every employee starts with the same knowledge — so we designed our trainings accordingly.

PharmaSoft pharmacovigilance trainings are offered at three separate levels based on your employees' area of duty and knowledge level:

Correct information makes a difference when given at the right level.

Training Language Options

Our pharmacovigilance trainings are prepared with multiple language options so they can be presented in the language your participants understand best:

🇹🇷 Turkish
🇬🇧 English
🇷🇺 Russian

We know the power of communication — choose the right language, increase the impact.

Assessment and Evaluation in Training

At the end of the training, a short evaluation exam is administered to see to what extent participants have understood the subject.

• An 80% success rate is expected for the participation to be considered valid.
• If this rate is not achieved, the training is offered again free of charge.

This evaluation is conducted both to measure the level of knowledge and to complete the learning process by identifying any points that remain missing.

Because a robust pharmacovigilance system begins with robust knowledge.

Certificate of Participation

Participants who successfully complete the training are issued a certificate of participation by PharmaSoft İlaç Bilişim Danışmanlık Hiz. Ltd. Şti.

This document shows that the relevant person participated in the training program and successfully completed its content.

Objective

This training is designed to increase the competence of pharmacovigilance teams in the detection and management of potential signals.

During the training, participants learn process steps such as:

🔍 Detection of potential signals
✅ Validation and confirmation
📊 Analysis and prioritization
📌 Creating and evaluating action recommendations

through practical examples.

The goal is to create strong teams that can handle potential signals correctly and feed decision mechanisms.

Training Content

📘 The training is prepared within the framework of current regulations and the Good Pharmacovigilance Practices (GVP) Guideline – Module VII: Signal Management.

🧠 Participants gain knowledge about all stages of signal management, such as identifying potential signals, validation, prioritization, evaluation, and creating action recommendations when necessary.

🔬 The content of the training also includes traditional and quantitative signal analysis methods, quality standards, and corporate responsibilities.

🎥 Presentations are enriched with visuals, videos, and case studies.

Participants don't just listen — they experience signal management both visually and practically.

Training Levels

Not every employee starts with the same knowledge — so we designed our trainings accordingly.

PharmaSoft pharmacovigilance trainings are offered at three separate levels based on your employees' area of duty and knowledge level:

Correct information makes a difference when given at the right level.

Training Language Options

Our pharmacovigilance trainings are prepared with multiple language options so they can be presented in the language your participants understand best:

🇹🇷 Turkish
🇬🇧 English

We know the power of communication — choose the right language, increase the impact.

Assessment and Evaluation in Training

At the end of the training, a short evaluation exam is administered to see to what extent participants have understood the subject.

• An 80% success rate is expected for the participation to be considered valid.
• If this rate is not achieved, the training is offered again free of charge.

This evaluation is conducted both to measure the knowledge level and to complete the learning process by identifying missing points.

Because a solid pharmacovigilance system starts with solid knowledge.

Certificate of Participation

Participants who successfully complete the training are issued a certificate of participation by PharmaSoft İlaç Bilişim Danışmanlık Hiz. Ltd. Şti.

This document indicates that the person attended the training program and successfully completed its content.

Objective

The aim of this training is to strengthen the competence of teams in identifying and managing drug-related risks.

Participants learn basic steps such as:

🔍 Detection and identification of risks
🛡️ Prevention and risk reduction strategies
📄 Preparation of the Risk Management Plan in line with current guidelines

both theoretically and practically.

The goal is not just to fill out the RMP; it is to understand the process and integrate it with correct risk management strategies.

Training Content

• The training is prepared based on the current regulation and Good Pharmacovigilance Practices (GVP) Guideline Module VI – Risk Management Systems.
• Participants learn the entire process step-by-step, from the structure of the RMP to the modular components of the safety specification, and from planning risk minimization activities to evaluating effectiveness.
• In the training, theoretical knowledge is reinforced with practical applications thanks to real-life examples, video lectures, and visual support.

💡 Because a Risk Management Plan should be created to actually work, not just to have prepared it.

Training Levels

Not every employee starts with the same knowledge — so we designed our trainings accordingly.

PharmaSoft pharmacovigilance trainings are offered at three separate levels based on your employees' area of duty and knowledge level:

Correct information makes a difference when given at the right level.

Training Language Options

Our pharmacovigilance trainings are prepared with multiple language options so they can be presented in the language your participants understand best:

🇹🇷 Turkish
🇬🇧 English

We know the power of communication — choose the right language, increase the impact.

Assessment and Evaluation in Training

At the end of the training, a short evaluation exam is administered to see to what extent participants have understood the subject.

• An 80% success rate is expected for the participation to be considered valid.
• If this rate is not achieved, the training is offered again free of charge.

This evaluation is conducted both to measure the knowledge level and to complete the learning process by identifying missing points.

Because a solid pharmacovigilance system starts with solid knowledge.

Certificate of Participation

Participants who successfully complete the training are issued a certificate of participation by PharmaSoft İlaç Bilişim Danışmanlık Hiz. Ltd. Şti.

This document indicates that the person attended the training program and successfully completed its content.

Objective

The first thing looked at in every audit, carrying the trace of every responsibility: PSMF.

This training provides participants with both theoretical knowledge and practical application on the preparation of the Pharmacovigilance System Master File in accordance with legislation, keeping it constantly updated, and archiving it.

🔍 File structure and mandatory contents
📅 Update processes and version control
📂 Audit-compliant digital and physical archiving methods

PSMF is not just a file; it is the memory of your pharmacovigilance system.

Training Content

• Our training is prepared within the framework of current regulations and the Good Pharmacovigilance Practices (GVP) Guideline Module V – Pharmacovigilance System Master File.
• The training handles the processes of creating, keeping up-to-date, and managing the Pharmacovigilance System Master File (PSMF) in an audit-ready manner in detail.
• Our presentations are supported by videos and visuals, proceeding through sample files.
• Participants learn to step-by-step identify and evaluate the sections that must be in the PSMF (e.g., pharmacovigilance processes, quality system, organizational structure, computerized systems, change control, etc.).
• In addition, topics frequently questioned in audits, such as tracking change history under Annex-I, version control, and use of logbooks, are conveyed in a practical manner.

Because a well-prepared and sustainable PSMF is not only a legal requirement; it is the backbone of an effective pharmacovigilance system.

Training Levels

Not every employee starts with the same knowledge — so we designed our trainings accordingly.

PharmaSoft pharmacovigilance trainings are offered at three separate levels based on your employees' area of duty and knowledge level:

Correct information makes a difference when given at the right level.

Training Language Options

Our pharmacovigilance trainings are prepared with multiple language options so they can be presented in the language your participants understand best:

🇹🇷 Turkish
🇬🇧 English

We know the power of communication — choose the right language, increase the impact.

Assessment and Evaluation in Training

At the end of the training, a short evaluation exam is administered to see to what extent participants have understood the subject.

• An 80% success rate is expected for the participation to be considered valid.
• If this rate is not achieved, the training is offered again free of charge.

This evaluation is conducted both to measure the knowledge level and to complete the learning process by identifying missing points.

Because a solid pharmacovigilance system starts with solid knowledge.

Certificate of Participation

Participants who successfully complete the training are issued a certificate of participation by PharmaSoft İlaç Bilişim Danışmanlık Hiz. Ltd. Şti.

This document indicates that the person attended the training program and successfully completed its content.

Objective

This training aims to increase participants' competence in the processes of preparing periodic benefit/risk evaluation reports (PBRER), archiving them, and submitting them to the Authority.

📄 Content structure in line with current guidelines
📊 Scientific analysis of the benefit/risk balance
📂 Preparation / archiving standards and timely notification obligations

All these topics are supported by theoretical knowledge along with real examples and practical explanations.

Preparing PBRER is not just a reporting process; it is developing a strategic view of the drug's life cycle.

Training Content

• The training is designed in line with the structure, content, scope, and evaluation processes of the PBRER, based on the Good Pharmacovigilance Practices Guideline – Module III.
• Participants learn to:
  📌 Evaluate the post-approval benefit/risk profile of the drug in the light of scientific data,
  📌 Effectively create report sections (introduction, summary, safety data, analyses, results),
  📌 Submit / archive PBRER on time in accordance with obligations.
• The training content is supported by sample reports, video lectures, and visuals; theoretical knowledge has been transformed into practice.

Preparing PBRER is not only a reporting obligation, but a responsibility to manage safety throughout the drug's life cycle.

Training Levels

Not every employee starts with the same knowledge — so we designed our trainings accordingly.

PharmaSoft pharmacovigilance trainings are offered at three separate levels based on your employees' area of duty and knowledge level:

Correct information makes a difference when given at the right level.

Training Language Options

Our pharmacovigilance trainings are prepared with multiple language options so they can be presented in the language your participants understand best:

🇹🇷 Turkish
🇬🇧 English

We know the power of communication — choose the right language, increase the impact.

Assessment and Evaluation in Training

At the end of the training, a short evaluation exam is administered to see to what extent participants have understood the subject.

• An 80% success rate is expected for the participation to be considered valid.
• If this rate is not achieved, the training is offered again free of charge.

This evaluation is conducted both to measure the knowledge level and to complete the learning process by identifying missing points.

Because a solid pharmacovigilance system starts with solid knowledge.

Certificate of Participation

Participants who successfully complete the training are issued a certificate of participation by PharmaSoft İlaç Bilişim Danışmanlık Hiz. Ltd. Şti.

This document indicates that the person attended the training program and successfully completed its content.