to increase the quality of notifications and the awareness of all employees on pharmacovigilance by making the adverse reaction reporting process effective.
Content
✅ The training content has been prepared within the framework of up-to-date regulations and guidelines with the interpretation and approval of Turkish Medicines and Medical Devices Agency.
✅ Our training presentations were enriched with videos and images.
Training Levels
Our trainings have been prepared at three different levels according to the job positions of your employees:
🔵 Beginner
🟠 Intermediate
⚫ Advanced
The trainings are available in
🇹🇷 Turkish,
🇬🇧 English
🇷🇺 Russian
language options.
Assessment And Evaluation
✅ At the end of the training, an exam is hold for the assessment and evaluation of the trainees.
✅ Training of the participants who cannot meet the success criteria of 80% is repeated.
Certificate Of Participation
A certificate of participation will be given at the end of the training by the Contracted Pharmacovigilance Services Provider PharmaSoft İlaç Bilişim Danışmanlık Hiz. Ltd. Şti.
Signal Management Training
OBJECTIVE
CONTENT
LEVELS
LANGUAGE
ASSESSMENT AND EVALUATION
CERTIFICATE OF PARTICIPATION
The aim of the training is
to increase competency in the areas of signal detection, validation, confirmation, analysis, prioritization, action suggestion and evaluation.
Content
✅ The training content has been prepared within the framework of the current PV regulation and Good Pharmacovigilance Practices (GVP) Guideline Module VII – Signal Management.
✅ Our training presentations were enriched with videos and images.
Training Levels
Our trainings have been prepared at in accordance with the job positions of your employees.
The trainings are available in
🇹🇷 Turkish,
🇬🇧 English
language options.
Assessment And Evaluation
✅ At the end of the training, an exam is hold for the assessment and evaluation of the trainees.
✅ Training of the participants who cannot meet the success criteria of 80% is repeated.
Certificate Of Participation
A certificate of participation will be given at the end of the training by the Contracted Pharmacovigilance Services Provider PharmaSoft İlaç Bilişim Danışmanlık Hiz. Ltd. Şti.
Risk Management Plan (RMP) Training
OBJECTIVE
CONTENT
LEVELS
LANGUAGE
ASSESSMENT AND EVALUATION
CERTIFICATE OF PARTICIPATION
The aim of the training is
to increase competency in the preparation of Risk Management Plan which is designed to detect, define, prevent or minimize the risks related to the drug in the light of up-to-date guide and practical applications.
Content
✅ The training content has been prepared within the framework of the current PV regulation and Good Pharmacovigilance Practices (GVP) Guideline Module VI – Risk Management Systems.
✅ Our training presentations were enriched with videos and images.
Training Levels
Our trainings have been prepared at in accordance with the job positions of your employees.
The trainings are available in
🇹🇷 Turkish,
🇬🇧 English
language options.
Assessment And Evaluation
✅ At the end of the training, an exam is hold for the assessment and evaluation of the trainees.
✅ Training of the participants who cannot meet the success criteria of 80% is repeated.
Certificate Of Participation
A certificate of participation will be given at the end of the training by the Contracted Pharmacovigilance Services Provider PharmaSoft İlaç Bilişim Danışmanlık Hiz. Ltd. Şti.
Pharmacovigilance System Master File (PSMF) Training
OBJECTIVE
CONTENT
LEVELS
LANGUAGE
ASSESSMENT AND EVALUATION
CERTIFICATE OF PARTICIPATION
The aim of the training is
to increase competency in the creation, recording, updating and archiving the Pharmacovigilance System Master File.
Content
✅ The training content has been prepared within the framework of the current PV regulation and Good Pharmacovigilance Practices (GVP) Guideline Module V – Pharmacovigilance System Master File.
✅ Our training presentations were enriched with videos and images.
Training Levels
Our trainings have been prepared at in accordance with the job positions of your employees.
The trainings are available in
🇹🇷 Turkish,
🇬🇧 English
language options.
Assessment And Evaluation
✅ At the end of the training, an exam is hold for the assessment and evaluation of the trainees.
✅ Training of the participants who cannot meet the success criteria of 80% is repeated.
Certificate Of Participation
A certificate of participation will be given at the end of the training by the Contracted Pharmacovigilance Services Provider PharmaSoft İlaç Bilişim Danışmanlık Hiz. Ltd. Şti.
Periodic Benefit-Risk Evaluation Report (PBRER) Training
OBJECTIVE
CONTENT
LEVELS
LANGUAGE
ASSESSMENT AND EVALUATION
CERTIFICATE OF PARTICIPATION
The aim of the training is
to increase competency in the preparation and archiving the periodical benefit/risk evaluation reports, and submitting these to the Institution in the light of up-to-date guide and practical applications.
Content
✅ The training content has been prepared within the framework of the current PV regulation and Good Pharmacovigilance Practices (GVP) Guideline Module III – Periodic Benefit-Risk Evaluation Report.
✅ Our training presentations were enriched with videos and images.
Training Levels
Our trainings have been prepared at in accordance with the job positions of your employees.
The trainings are available in
🇹🇷 Turkish,
🇬🇧 English
language options.
Assessment And Evaluation
✅ At the end of the training, an exam is hold for the assessment and evaluation of the trainees.
✅ Training of the participants who cannot meet the success criteria of 80% is repeated.
Certificate Of Participation
A certificate of participation will be given at the end of the training by the Contracted Pharmacovigilance Services Provider PharmaSoft İlaç Bilişim Danışmanlık Hiz. Ltd. Şti.