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- Price: €699 gross / year / user -> ~€8 per course
- Number of courses: 80+
- Time to complete: 1 year
- Content Limit: Unlimited
- Job Search Support: Included
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COURSE LIBRARY
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Open a course to review its content, duration and learning outcomes. Every course below is included while your subscription is active.
Courses included in this subscription
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Additional risk minimization measures
PharmacovigilanceRegulatory AffairsKarolina Smyl, Karolina Wawrzyniak
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Assessment and Medical Evaluation of ICSR
PharmacovigilanceClinical TrialsAleksandra MalickaCertified by: -
Building an Effective SOP and Quality Management System (QMS) for Clinical Research Sites
Clinical TrialsLucas Dzioba -
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Cosmetic product safety report and the role of the responsible person
PharmacovigilanceEwelina DrelichCertified by: -
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CTD module 3 – Quality (EU). Active Pharmaceutical Ingredient (API) / Drug Substance in medicinal products for Human use
Regulatory AffairsPaweł Pawłowski -
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Dossier of authorized medicinal products in format of CTD, NeeS and eCTD
Regulatory AffairsKatarzyna Kopacz-Zakrzewska -
Effective collaboration between the Study Coordinator and the Clinical Research Monitor – Practical aspects of Monitoring Visits
Clinical TrialsErnest Szubert, Monika Czerwiński -
Entering data into the Pharmacovigilance database system
PharmacovigilanceAleksandra MalickaCertified by: -
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Fees payable to Regulatory Agencies on the example of EMA and URPL in Poland
Regulatory AffairsKatarzyna Kopacz-Zakrzewska -
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Guidelines, regulations, and tools related to Trial Master File
Clinical TrialsKatarzyna PieńczukCertified by: -
How to prepare case narrative and sender’s comment
PharmacovigilanceAleksandra MalickaCertified by: -
Introduction to audit and inspection report
PharmacovigilanceClinical TrialsAgnieszka SokółCertified by: -
Introduction to bioequivalence of medicinal products
Clinical TrialsRegulatory AffairsJoanna Kupidura -
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Introduction to electronic submission of documentation and Electronic Application Form
Regulatory AffairsJoanna Kupidura -
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Introduction to individual development plan
PharmacovigilanceClinical TrialsRegulatory AffairsMarcin Gołembski -
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Introduction to Module 5 of the registration dossier (Clinical study reports)
Regulatory AffairsJoanna Kupidura -
Introduction to organized post-marketing data collection systems
PharmacovigilanceClinical TrialsMonika Nowak, Marek HurdaCertified by: -
Introduction to Personal Data Protection in the pharmaceutical industry
PharmacovigilanceAnna Buczyńska-BorowyCertified by: -
Introduction to Pharmacovigilance Agreements and Service Provider Agreements
PharmacovigilanceKarolina Wawrzyniak, Anna KończakCertified by: -
Introduction to planning and performing monitoring visits
Clinical TrialsErnest SzubertCertified by: -
Introduction to Quality Management System
PharmacovigilanceClinical TrialsAgnieszka SokółCertified by: -
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Introduction to role of Qualified Person Responsible for Pharmacovigilance
PharmacovigilanceKatarzyna Baltyn, Anna KończakCertified by: -
Introduction to safety monitoring in clinical trials
PharmacovigilanceClinical TrialsMarek Hurda, Monika NowakCertified by: -
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Introduction to the activities performed by Regulatory Affairs Department
Regulatory AffairsJoanna Kupidura -
Introduction to the management of ICSRs
PharmacovigilanceClinical TrialsAleksandra MalickaCertified by: -
Introduction to the Marketing Authorisation application form and the basis for the eAF – Electronic Application Form
Regulatory AffairsJulita Wójcik -
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Introduction to types of the procedures for registration of medicinal products
Regulatory AffairsJoanna Kupidura -
Introduction to Vaccine Safety Surveillance in EU
PharmacovigilanceAnastazja MarkowskaCertified by: -
Key updates on GVP Module XVI Risk minimisation measures (Rev 3) and Module XVI Addendum II
PharmacovigilanceKarolina Wawrzyniak -
Legal Regulations and Guidelines concerning Pharmacovigilance
PharmacovigilanceMonika TrojanCertified by: -
Management of an Investigational Product at a clinical site
Clinical TrialsErnest SzubertCertified by: -
Management of Company Core Safety Information
PharmacovigilanceRegulatory AffairsJulita Wójcik, Anna Kończak -
Management of Periodic Safety Update Report
PharmacovigilanceKarolina Smyl, Karolina WawrzyniakCertified by: -
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Managing Product Information updates depending on the type of procedure
Regulatory AffairsKatarzyna Kopacz-Zakrzewska -
Medical Literature Monitoring based on journals review
PharmacovigilanceMarek Wykręt-BielskiCertified by: -
Medicines under additional monitoring, the black triangle
PharmacovigilanceRegulatory AffairsKatarzyna Kopacz-Zakrzewska -
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Moving from hype to reality: how AI can really help tackle pharma challenges
PharmacovigilanceJulia Matuszewska, Jerzy Biernacki +2 -
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Navigating EU CTR 536/2014 with transitioning from CTD
PharmacovigilanceClinical TrialsRegulatory AffairsKatarzyna Kopacz-Zakrzewska -
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PRAC, CHMP, CMDh – the role and responsibilities that impact on the PV activities performed by MAH
PharmacovigilanceRegulatory AffairsAndrzej CzesławskiCertified by: -
Practical aspects of Personal Data Protection in Pharmacovigilance and Clinical Trials
PharmacovigilanceClinical TrialsAnna Buczyńska-BorowyCertified by: -
Practical aspects of the review of the medical literature
PharmacovigilanceMarek Wykręt-BielskiCertified by: -
Preparation to audits and inspections in clinical trials
Clinical TrialsAgnieszka SokółCertified by: -
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PSUR single assessment procedure and informal Work-Sharing procedure for follow-up for PSUSA for NAPs
PharmacovigilanceAndrzej CzesławskiCertified by: -
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Requirements for Product Information of medicinal products
Regulatory AffairsKatarzyna Kopacz-Zakrzewska -
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The specifics of the Polish market in terms of the Risk Management Plan
PharmacovigilanceAndrzej CzesławskiCertified by: -
Transport of Biological Materials and IATA Rules in the Context of Clinical Research
Clinical TrialsMonika Czerwiński -
What is MedDRA and how is it used?
PharmacovigilanceRegulatory AffairsAleksandra MalickaCertified by: -
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Number of courses included: 36 -
Clinical Trials Subscription
399.00€ / YearLearning area: Clinical TrialsSubscribe
Number of courses included: 42 -
Pharmacovigilance Subscription
399.00€ / YearLearning area: PharmacovigilanceSubscribe
Number of courses included: 40
Courses included in this subscription
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-
-
-
Medical Literature Monitoring based on journals review
PharmacovigilanceMarek Wykręt-BielskiCertified by: -
Moving from hype to reality: how AI can really help tackle pharma challenges
PharmacovigilanceJulia Matuszewska, Jerzy Biernacki +2 -
-
Key updates on GVP Module XVI Risk minimisation measures (Rev 3) and Module XVI Addendum II
PharmacovigilanceKarolina Wawrzyniak -
Introduction to electronic submission of documentation and Electronic Application Form
Regulatory AffairsJoanna Kupidura -
Introduction to the activities performed by Regulatory Affairs Department
Regulatory AffairsJoanna Kupidura -
-
PRAC, CHMP, CMDh – the role and responsibilities that impact on the PV activities performed by MAH
PharmacovigilanceRegulatory AffairsAndrzej CzesławskiCertified by: -
-
Medicines under additional monitoring, the black triangle
PharmacovigilanceRegulatory AffairsKatarzyna Kopacz-Zakrzewska -
-
Effective collaboration between the Study Coordinator and the Clinical Research Monitor – Practical aspects of Monitoring Visits
Clinical TrialsErnest Szubert, Monika Czerwiński -
Introduction to organized post-marketing data collection systems
PharmacovigilanceClinical TrialsMonika Nowak, Marek HurdaCertified by: -
Introduction to Module 5 of the registration dossier (Clinical study reports)
Regulatory AffairsJoanna Kupidura -
-
-
-
Additional risk minimization measures
PharmacovigilanceRegulatory AffairsKarolina Smyl, Karolina Wawrzyniak -
Requirements for Product Information of medicinal products
Regulatory AffairsKatarzyna Kopacz-Zakrzewska -
Introduction to the Marketing Authorisation application form and the basis for the eAF – Electronic Application Form
Regulatory AffairsJulita Wójcik -
-
-
-
Dossier of authorized medicinal products in format of CTD, NeeS and eCTD
Regulatory AffairsKatarzyna Kopacz-Zakrzewska -
-
-
-
-
Navigating EU CTR 536/2014 with transitioning from CTD
PharmacovigilanceClinical TrialsRegulatory AffairsKatarzyna Kopacz-Zakrzewska -
-
-
The specifics of the Polish market in terms of the Risk Management Plan
PharmacovigilanceAndrzej CzesławskiCertified by: -
Entering data into the Pharmacovigilance database system
PharmacovigilanceAleksandra MalickaCertified by: -
-
Introduction to Vaccine Safety Surveillance in EU
PharmacovigilanceAnastazja MarkowskaCertified by: -
-
-
Practical aspects of Personal Data Protection in Pharmacovigilance and Clinical Trials
PharmacovigilanceClinical TrialsAnna Buczyńska-BorowyCertified by: -
Transport of Biological Materials and IATA Rules in the Context of Clinical Research
Clinical TrialsMonika Czerwiński -
Introduction to Pharmacovigilance Agreements and Service Provider Agreements
PharmacovigilanceKarolina Wawrzyniak, Anna KończakCertified by: -
-
Practical aspects of the review of the medical literature
PharmacovigilanceMarek Wykręt-BielskiCertified by: -
Management of Periodic Safety Update Report
PharmacovigilanceKarolina Smyl, Karolina WawrzyniakCertified by: -
-
-
Guidelines, regulations, and tools related to Trial Master File
Clinical TrialsKatarzyna PieńczukCertified by: -
-
Introduction to individual development plan
PharmacovigilanceClinical TrialsRegulatory AffairsMarcin Gołembski -
Introduction to safety monitoring in clinical trials
PharmacovigilanceClinical TrialsMarek Hurda, Monika NowakCertified by: -
-
Management of an Investigational Product at a clinical site
Clinical TrialsErnest SzubertCertified by: -
-
Preparation to audits and inspections in clinical trials
Clinical TrialsAgnieszka SokółCertified by: -
-
-
-
How to prepare case narrative and sender’s comment
PharmacovigilanceAleksandra MalickaCertified by: -
-
Cosmetic product safety report and the role of the responsible person
PharmacovigilanceEwelina DrelichCertified by: -
PSUR single assessment procedure and informal Work-Sharing procedure for follow-up for PSUSA for NAPs
PharmacovigilanceAndrzej CzesławskiCertified by: -
-
-
What is MedDRA and how is it used?
PharmacovigilanceRegulatory AffairsAleksandra MalickaCertified by: -
-
Introduction to types of the procedures for registration of medicinal products
Regulatory AffairsJoanna Kupidura -
-
Introduction to role of Qualified Person Responsible for Pharmacovigilance
PharmacovigilanceKatarzyna Baltyn, Anna KończakCertified by: -
Introduction to the management of ICSRs
PharmacovigilanceClinical TrialsAleksandra MalickaCertified by: -
Assessment and Medical Evaluation of ICSR
PharmacovigilanceClinical TrialsAleksandra MalickaCertified by: -
-
Introduction to planning and performing monitoring visits
Clinical TrialsErnest SzubertCertified by: -
-
-
-
-
-
Introduction to Personal Data Protection in the pharmaceutical industry
PharmacovigilanceAnna Buczyńska-BorowyCertified by: -
-
Introduction to audit and inspection report
PharmacovigilanceClinical TrialsAgnieszka SokółCertified by: -
-
Management of Company Core Safety Information
PharmacovigilanceRegulatory AffairsJulita Wójcik, Anna Kończak -
Fees payable to Regulatory Agencies on the example of EMA and URPL in Poland
Regulatory AffairsKatarzyna Kopacz-Zakrzewska -
CTD module 3 – Quality (EU). Active Pharmaceutical Ingredient (API) / Drug Substance in medicinal products for Human use
Regulatory AffairsPaweł Pawłowski -
-
-
-
Building an Effective SOP and Quality Management System (QMS) for Clinical Research Sites
Clinical TrialsLucas Dzioba -
Legal Regulations and Guidelines concerning Pharmacovigilance
PharmacovigilanceMonika TrojanCertified by: -
-
-
Managing Product Information updates depending on the type of procedure
Regulatory AffairsKatarzyna Kopacz-Zakrzewska -
Introduction to bioequivalence of medicinal products
Clinical TrialsRegulatory AffairsJoanna Kupidura -
Introduction to Quality Management System
PharmacovigilanceClinical TrialsAgnieszka SokółCertified by: