Check our tailor-made
online trainings on Pharmacovigilance

Pharmacovigilance Training
Signal Management Training
Risk Management Plan (RMP) Training
Pharmacovigilance System Master File (PSMF) Training
Periodic Benefit-Risk Evaluation Report (PBRER) Training

Pharmacovigilance
Training

  • OBJECTIVE
  • CONTENT
  • LEVELS
  • LANGUAGE
  • ASSESSMENT AND EVALUATION
  • CERTIFICATE OF PARTICIPATION

The aim of the training is

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.
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If you need any information or request a demo about our services and products, please contact us by following this link.

Contact Us

Fetih Mah. Tahralı Sk. Kavakyeli İş Merkezi No:7 A Blok Kat:10 D: 26
Ataşehir/İstanbul/Turkey

+90 216 326 77 12
📠 +90 216 428 39 71
📧 contact@pharmasoft.com.tr

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